A Phase 2 interventional study of Cediranib in Bowel Obstruction, Ovarian Cancer and Fallopian Tube Cancer, sponsored by Prof Gordon Jayson. Completed at 1 site in United Kingdom. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Prof Gordon Jayson · Phase 2, Interventional, and Treatment
Ovarian cancer can often grow and cause obstructions in the bowel. These obstructions usually cannot be removed with surgery and can be fatal. This trial is testing whether a drug called cediranib can be used safely together with paclitaxel chemotherapy to treat ovarian cancer in women at risk of bowel obstructions. All participants will receive the cediranib/paclitaxel combination, and if the cancer worsens the participant will stop receiving paclitaxel and may receive an additional drug, olaparib, together with cediranib.
Ovarian cancer is the fourth most common cause of female cancer death and the commonest cause of gynaecological cancer death, accounting for 4,000 lives a year in the UK and 22,000 in the United States (1,2). The most common cause of death is malignant bowel obstruction, which occurs because of tumour physically and neurologically arresting bowel function (3).
New treatment strategies are required to address malignant bowel obstruction, which usually occurs in patients whose disease has become resistant to platinum-based chemotherapy. Several studies have reported higher response rates and increased PFS when a VEGF pathway inhibitor is combined with cytotoxic therapy in the first line (4,5), platinum-sensitive (6,7) and platinum-resistant recurrent disease settings (8). In the AURELIA study, the addition of the anti-angiogenic, monoclonal anti-VEGF antibody, bevacizumab, to physician's choice of cytotoxic agent significantly improved PFS. However, this study excluded patients who had received more than three previous regimens of treatment and those with clinical or radiological features of bowel obstruction on the basis that previous data had shown that the administration of bevacizumab to patients with prior bowel surgery, pelvic disease involving the recto sigmoid or symptoms of bowel obstruction would significantly increase the risk of bowel perforation(9), which can be fatal.
The above data demonstrate that there is an unmet need for a VEGF inhibitor that can be safely combined with cytotoxic therapy, which would increase the response rate and PFS in this population. The MITO-11 study demonstrated the safety and potential efficacy of the combination of pazopanib with weekly paclitaxel in platinum resistant disease (11) and the investigators have demonstrated in the in-house trial of cediranib with radiotherapy in colorectal cancer (DREAM trial; manuscript in preparation) that cediranib is effective and safe in the context of significant bowel wall disease, where bevacizumab has been previously reported to induce significant toxicity (12,13).
Taking these findings together, there is a strong rationale to develop a safe VEGF inhibitor-combination regimen in the setting of patients at risk of subacute bowel obstruction from ovarian cancer. Here, the investigators will evaluate the safety and efficacy of the potent VEGF receptor tyrosine kinase inhibitors (RTKi), cediranib, with weekly paclitaxel/nab-paclitaxel in women who are at risk of developing malignant bowel obstruction from ovarian cancer; a population in which bevacizumab is contra-indicated. Any risk to the patient's bowel will be minimized by bringing the abdominal disease under control with weekly paclitaxel /nab-paclitaxel for 1-3 cycles (3-9 weeks) before introducing the combination of paclitaxel/nab-paclitaxel with cediranib.
There is a critical need to develop effective and safe treatment regimens for patients with subacute bowel obstruction from ovarian cancer. Several trials have demonstrated the clinical benefit of adding bevacizumab to cytotoxic therapy in various settings in the disease yet in sub-acute bowel obstruction or in moderately heavily pre-treated patients, the antibody is contra-indicated due to the risk of bowel perforation or fistula.
Several findings suggest that VEGF RTKi are safer than antibodies in the presence of bowel dysfunction while preserving the efficacy advantage of the combination regimen. Here, we will evaluate the safety of the potent VEGF RTKi, cediranib, in combination with weekly paclitaxel in a cohort of patients at risk of developing malignant bowel obstruction, for whom bevacizumab is contraindicated.
Paclitaxel will be administered in CEBOC at 80mg/m2/week on days 1, 8 and 15 of a 3 week schedule, where the plan will be for patients to receive 6 cycles of treatment. The treatment is being given on a continuous weekly schedule in the same way that paclitaxel was prescribed in two large randomised trials of paclitaxel with a VEGF inhibitor. In one trial the VEGF inhibitor was the monoclonal anti-VEGF antibody, bevacizumab (14) and in the other, the VEGF receptor tyrosine kinase inhibitor, pazopanib was used (15). These two trials demonstrated that weekly paclitaxel can be safely and effectively combined with a VEGF inhibitor. However, the pazopanib trial, which involved administration of a VEGF inhibitor of the same class as cediranib, reported that 30% of patients incurred grade 3 or 4 neutropenia yet the investigators had restricted entry to the study to patients who had only received up to 3 previous lines of treatment. In CEBOC, patients can have received any number of previous lines of treatment and therefore to mitigate the risk of neutropenia, the trial involves the prescription of paclitaxel (16) at 70mg/m2/week rather than the slightly higher dose used in these two trials. As there is no evidence of a dose-response effect beyond standard doses of paclitaxel, the proposed regimen of 70mg/m2/week remains a standard of care.
The dose of cediranib selected for CEBOC is 20mg/day, which was biologically and clinically active in early phase clinical trials (17). Early attempts to combine cediranib with cytotoxic chemotherapy using a dose of the former at 30mg/day proved intolerable and therefore the standard combination dose of cediranib in recurrent ovarian cancer was 20mg/day.
Once patients in CEBOC have completed a maximum of 18 weeks of treatment with paclitaxel, those who have stable disease or better can continue taking cediranib alone at 20mg/day; again a dose that was used as maintenance therapy in ICON6 (18). At the point of developing progressive disease in CEBOC patients will need to fulfil another set of eligibility criteria but if they remain eligible, they can then supplement the cediranib with olaparib. The reason that the cediranib dose will remain 20mg/day in this component of CEBOC is because the phase II trial that described the activity of the combination (19) initially involved administration of a dose of cediranib 30mg/day but this had to be reduced in 77% of patients to 20mg/day. Given the amount of previous treatment the patients will have received at this point in CEBOC it is appropriate to use the more tolerable dose of cediranib, namely 20mg/day.
In CEBOC, patients who develop progressive disease while taking cediranib and who remain eligible to continue in the trial, will be prescribed olaparib tablets 300mg bd in addition to cediranib 20mg/day. The original formulation of olaparib was as 50mg capsules and the dose of capsules was 400mg bd. As the capsules only contained 50mg olaparib, the number of capsules patients had to take was considerable. Because of this, a tablet formulation of olaparib was developed, which resulted in the same exposure to olaparib when 300mg tablets twice daily were compared with capsules at 400mg twice daily, yielding similar clinical efficacy and toxicity while reducing the pill burden to four 150mg tablets per day (20).
The recommended monotherapy tablet dose of 300mg bd has now been evaluated as maintenance therapy in BRCA-mutation associated platinum-sensitive ovarian cancer in a placebo-controlled randomised phase 3 trial (21) where it demonstrated similar efficacy to that reported for the capsule formulation in the initial seminal randomised phase II trial which resulted in EMEA approval for olaparib (7,18).
A further phase II trial confirmed that the all-tablet cediranib-olaparib combination was associated with toxicities consistent with those observed when olaparib capsules were given in combination with cediranib (22). This study established two acceptable options for phase II dosing; either cediranib 20 mg once daily and olaparib 300 mg twice daily, or cediranib 30 mg once daily and olaparib 200 mg twice daily. Based on the earlier combination study showing that a high proportion of cediranib dose reductions were required from a starting dose of 30 mg once daily (19), therefore for the purpose of this trial, participants will receive cediranib 20 mg once daily and olaparib tablets 300 mg twice daily. Intensive symptom management guidelines will also be applied within this trial.
104 studies on the registry are indexed under Intestinal Obstruction; 15 are open to participants now.
This study's enrollment of 30 is below the median of 62 across 54 interventional studies indexed under Intestinal Obstruction.
Browse Intestinal Obstruction studies →This is the only study on the registry with Prof Gordon Jayson as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Prior to paclitaxel and cediranib
Inclusion Criteria: Prior to switching to olaparib and cediranib
Exclusion Criteria: Prior to paclitaxel and cediranib
Uncontrolled or seizures. A scan to confirm the absence of brain metastases is not required. Central nervous system :
Pregnant or lactating. Pregnancy status in women of child bearing potential will be confirmed via a serum or urine pregnancy test prior to randomisation, monthly during the treatment period, and at the end of treatment assessment. In addition, women of child bearing potential MUST be willing to ensure they use effective for four weeks before entering the trial, throughout the treatment period and for six months following the end of treatment. Acceptable methods of contraception are:
i. true sexual abstinence (when this is in line with the preferred and usual lifestyle of the participant) ii. a combination of male condom plus one of:
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, unstable angina, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, resting ECG with clinically significant abnormal findings, grade III/IV cardiac failure, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent. (LVEF) \< lower limit of normal (LLN) per institutional guidelines, or \<55%, if threshold for normal not otherwise specified by institutional guidelines, for patients with the following risk factors:
Exclusion Criteria: Prior to switching to olaparib and cediranib
1. Meet exclusion criteria listed previously as points: 1-7, 9-11, 13-18, 20-21.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cediranib 20mg/day with weekly paclitaxel 70mg/m2/week. At the point of developing progressive disease (PD), patients will have the option of ceasing paclitaxel and continuing cediranib 20mg/day with olaparib 300mg bd continuously until further PD occurs.
Drug: Cediranib
Cediranib in combination with weekly paclitaxel
Also known as: AZD-2171, cediranib maleate
This study also gives Olaparib. No intervention listed here names it: that was found by reading the record.
The number of patients free of grade III-V gastrointestinal perforation or fistula causally related to cediranib.
The number of patients free of grade III-V gastrointestinal perforation or fistula during cediranib treatment. This is causally related to cediranib or the cediranib olaparib combination, during cediranib treatment until patient withdraws, dies or has been treated with cediranib for at least 18 weeks, and for 28 days following the last dose. The proportion will be calculated with an exact 95% confidence interval (CI) calculated using the Clopper-Pearson method.
Time frame: From date of registration until 28 days after the last dose of cediranib, or until death, whichever occurs first. Minimum assessment period: 18 weeks of cediranib treatment or until prior withdrawal/death.
Proportion of participants hospitalised for bowel obstruction
Analyses will consist of the proportion of patients developing bowel obstruction (including hospital admission for bowel obstruction reported as an SAE).
Time frame: From date of registration until patient withdraws from/stops cediranib treatment, dies or has been treated with cediranib for at least 18 weeks. All patients will be followed up for 28 days after the last dose of study drug.
The number of grade III or more toxicities excluding gastrointestinal perforation/ fistula as assessed by CTCAE 4.03.
Adverse events will be coded using CTCAE version 4.03 terminology, which maps directly to the Medical Dictionary for Regulatory Activities (MedDRA). All AEs will be summarised by severity (grade 1/2, grade 3 and grade 4+), toxicity and timing (baseline and worst toxicity reported overall for cediranib and by treatment regimen in Component 1).
Time frame: From date of registration until patient withdraws from/stops cediranib treatment, dies or has been treated with cediranib for at least 18 weeks. All patients will be followed up for 28 days after the last dose of study drug.
Total dose of paclitaxel delivered in Component 1
Total cumulative dose of paclitaxel administered during Component 1. Summarized as median with interquartile range.
Time frame: From first dose of paclitaxel to last dose of paclitaxel, up to 18 weeks
Relative dose intensity of paclitaxel in Component 1
Median relative dose intensity of paclitaxel, calculated as (delivered dose intensity / standard dose intensity) × 100%. Delivered dose intensity = total dose administered (mg/m²) divided by actual treatment duration (weeks). Standard dose intensity = 70 mg/m²/week. Summarized as median with interquartile range.
Time frame: From first dose of paclitaxel to last dose of paclitaxel, up to 18 weeks
Total dose of cediranib delivered in Component 1
Total cumulative dose of cediranib administered during Component 1. Summarized as median with interquartile range.
Time frame: From first dose of cediranib to last dose of cediranib or data cutoff, up to 18 weeks
Relative dose intensity of cediranib in Component 1
Median relative dose intensity of cediranib, calculated as (delivered dose intensity / standard dose intensity) × 100%. Delivered dose intensity = total dose administered (mg) divided by actual treatment duration (days). Standard dose intensity = 20 mg/day. Summarized as median with interquartile range.
Time frame: From first dose of cediranib to last dose of cediranib or data cutoff, up to 18 weeks
Investigator-determined ORR assessed by RECIST 1.1 within 18 weeks of starting paclitaxel
The Intention-to-Treat (ITT) population will constitute all registered subjects. All participants who start cediranib and receive at least 5 days' treatment will be included in the per protocol (PP) population. The ORR (participants demonstrating either complete response or partial response within the first 18 weeks) will be summarised as the proportion of patients with objective response with an exact 95% confidence interval in the ITT and PP populations. Response of target lesions, non-target lesions and overall response at each RECIST assessment will also be summarised. Investigator-determined ORR assessed by RECIST 1.1 within 18 weeks of starting paclitaxel or nab-paclitaxel.
Time frame: Within 18 weeks of starting paclitaxel.
Progression-Free Survival (PFS) to First Progression
Time from date of registration to the date of investigator-assessed objective disease progression per RECIST version 1.1, or death from any cause in the absence of radiologic progression. Progression is defined as either radiologic progression (per RECIST 1.1) or clinical progression as reported on the RECIST case report form.
Time frame: From date of registration until first documented disease progression or death, whichever occurs first, assessed up to 36 months
Overall survival (OS) defined as the time from date of registration to date of death
Overall survival (OS) defined as the time from date of registration to date of death
Time frame: From date of registration until patient dies or completes follow up. Patients will be followed up on protocol until death has occurred or the patient withdraws permission, assessed up to 36 months.
Treatment compliance of component 2
Assessed by the median relative dose intensity of olaparib and cediranib in Component 2 (calculated as below), total dose delivered and dose dose intensity summarised with the interquartile range (IQR).The median relative dose intensity + (DDI/SDI)×100%, where DDI=Delivered dose intensity and SDI=Standard dose intensity: DDI=(Delivered total dose, in relevant units)/(actual time to complete chemotherapy). Delivered total dose=Total amount of drug actually administered over chemotherapy course. Actual time to complete chemotherapy= Observed number of days between initiation and final receipt of chemotherapy plus expected number of days for missing cycles. SDI= (Standard total dose, in relevant units)/(standard time to complete chemotherapy, in days). Standard total dose= Total standard amount of drug for administration over chemotherapy course. Standard time to complete chemotherapy= Standard number of days between initiation and final receipt of chemotherapy.
Time frame: During the duration of treatment, up to 36 months. Treatment on component 2 will continue until second PD unless one of the following occurs: • patient withdrawal of consent. • unacceptable toxicity. • intolerance to treatment.
Association of prior bevacizumab exposure with treatment-related toxicities, objective response rate, progression free survival, and overall survival
This outcome will summarize adverse events (graded using NCI Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.03), objective response rate (ORR; determined by RECIST version 1.1 criteria), progression free survival (PFS; time from registration to radiologic or clinical progression, or death from any cause), and overall survival (OS; time from registration to death from any cause) according to prior bevacizumab exposure status (yes/no). The proportion of participants with prior bevacizumab treatment will be calculated, and toxicities, ORR, PFS, and OS will be summarized descriptively (no formal statistical tests performed).
Time frame: From date of registration until death, withdrawal, or database lock, assessed up to 36 months
The number of grade III or more toxicities when on olaparib/cediranib treatment
To determine the toxicities, after switching to olaparib/cediranib (with or without concurrent paclitaxel/ nab-paclitaxel) at first point of disease progression. Adverse events will be coded using CTCAE version 4.03 terminology, which maps directly to the Medical Dictionary for Regulatory Activities (MedDRA). All AEs will be summarised by severity (grade 1/2, grade 3 and grade 4+), toxicity and timing (baseline and worst toxicity reported overall in component 2).
Time frame: For the duration of treatment, up to 36 months. Treatment on component 2 will continue until second PD unless one of the following occurs: • patient withdrawal. • unacceptable toxicity. • intolerance to treatment.
Association of BRCA1/2 mutation status with treatment related toxicities, objective response rate, progression free survival, and overall survival in patients receiving olaparib plus cediranib
This outcome will summarize adverse events (graded using the NCI Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.03), objective response rate (ORR; determined by Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1), progression free survival (PFS; time from registration to radiologic or clinical progression or death from any cause, whichever occurs first), and overall survival (OS; time from registration to death from any cause) according to germline BRCA1/2 mutation status (pathogenic mutation vs wild type). The proportion of participants with pathogenic germline BRCA1/2 mutations will be calculated. Toxicities, ORR, PFS, and OS will be summarized descriptively by BRCA status; no formal significance testing will be performed.
Time frame: From date of registration until death, withdrawal, or database lock, assessed up to 36 months
ORR and time to further progression from the dates of switching to olaparib.
To determine the Objective Response Rate and time to further progression after switching to olaparib/cediranib (with or without concurrent paclitaxel/ nab-paclitaxel) at first point of disease progression. The ORR (participants demonstrating either complete response or partial response within the first 18 weeks) will be summarised as the proportion of patients with objective response with an exact 95% confidence interval in the population that switches. Response of target lesions, non-target lesions and overall response at each RECIST assessment will be summarised. PFS measured as the time from date of switching to date of investigator-assessed objective progression via RECIST v1.1 or death from any cause in the absence of progression. Progression will be defined as radiological progression as determined by RECIST 1.1 or clinical progression if this is reported on a RECIST CRF. OS defined as the time from date of registration to date of death.
Time frame: ORR and PFS from date of switching until patient withdraws, dies or completes follow up, assessed up to 36 months. OS defined as the time from date of switching to date of death.
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Studies of the drug tested here: Cediranib