A Phase 2 interventional study of Olaparib Pill and AZD6738 in High Grade Serous Carcinoma, sponsored by University of Pennsylvania. Completed at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of Pennsylvania · Phase 2, Interventional, and Treatment
Investigational agent, AZD6738 will be given in combination with Olaparib to women with recurrent ovarian cancer (platinum-sensitive or platinum-resistant).
This study will determine if using Olaparib in combination with AZD6738 is safe and tolerable and also determine the objective response rate and progression free survival of combination of AZD6738 and Olaparib in women with recurrent ovarian cancer in distinct platinum-sensitive and platinum-resistant cohorts.
University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For inclusion in the study, patients must fulfill the following criteria:
Germline BRCA mutation status:
Platinum-sensitive is defined as recurrence >6 months by RECIST 1.1 imaging from last platinum. Platinum-resistant is defined as recurrence ≤ 6 months by RECIST 1.1 imaging from last platinum regimen).
Prior treatment with a PARPi is permitted but not mandatory for Cohorts A and B and Cohort D Part I. Prior treatment with PARPi is mandatory for Cohort C and D Part II. If a patient has received a prior PARPi, then the patient must have demonstrated a clinical benefit of PARPi treatment by an initial response (by CA-125 or imaging) to PARPi treatment or clinical benefit from PARPi treatment as maintenance therapy followed by disease progression for enrollment onto Cohort C and D Part II. Clinical benefit for maintenance is defined as:
If the prior PARP inhibitor used was olaparib, it must have been tolerated without dose reduction for hematological toxicities. Olaparib must have been tolerated at a dose of 300mg twice daily for Arms A, B, \& C. Olaparib must have been tolerated at a dose of 200 mg twice daily or higher for Arm D.
For Cohort C and D Part II, patients may not have received cytotoxic chemotherapy in the interval between PARPi monotherapy and enrollment.
defined as:
Exclusion criteria:
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.
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 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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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 number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
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.
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).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
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.
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.
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.
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
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.
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.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (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.
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.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
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.
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.
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.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
Cohort A: Recurrent platinum-sensitive ovarian cancer (progression greater than 6 months from last receipt of platinum-based chemotherapy), approximately 37 patients could be treated with an interim analysis after 17 subjects. All patients will receive the combination of AZD6738 and olaparib. Patients will be administered olaparib orally twice daily at 300 mg BD. Patients will be administered AZD6738 orally once daily at 160 mg on days 1 to 7. For ease of administration, the AZD6738 should be administered at the same time as one of the olaparib doses and thus with one glass of water.
Drug: Olaparib Pill · Drug: AZD6738
Cohort B: Recurrent platinum-resistant ovarian cancer (progression less than or equal to 6 months of the last receipt), approximately 37 patients could be treated with an interim analysis after 12 subjects. All patients will receive the combination of AZD6738 and olaparib. Patients will be administered olaparib orally twice daily at 300 mg BD. Patients will be administered AZD6738 orally once daily at 160 mg on days 1 to 7. For ease of administration, the AZD6738 should be administered at the same time as one of the olaparib doses and thus with one glass of water.
Drug: Olaparib Pill · Drug: AZD6738
Cohort C: PARP inhibitor (PARPi) resistant (subjects who have progressed on a PARPi), patients must be platinum-sensitive, and have a germline or somatic BRCA mutation or an HRD mutation. Approximately 12 subjects could be treated. All patients will receive the combination of AZD6738 and olaparib. Patients will be administered olaparib orally twice daily at 300 mg BD. Patients will be administered AZD6738 orally once daily at 160 mg on days 1 to 7. For ease of administration, the AZD6738 should be administered at the same time as one of the olaparib doses and thus with one glass of water.
Drug: Olaparib Pill · Drug: AZD6738
Cohort D Part I: Patients will be platinum sensitive/platinum resistant ovarian cancer. Patient may or may not have received prior PARPi and will be enrolled irrespective of their BRCA status. The number of subjects treated will depend on the number of dose levels explored with a minimum of 12 subjects up to 30 subjects. All patients will receive the combination of AZD6738 and olaparib. Cohort D will take a lower dose of olaparib (100-200 mg daily for a 28-day cycle) and a higher dose of AZD6738 (160-320 mg daily for about 14 days). Three to five dosing schedules will be evaluated.
Drug: Olaparib Pill · Drug: AZD6738
Cohort D Part II: Patients with ovarian cancer who are PARP inhibitor (PARPi) resistant (patients who have progressed on a PARPi). Patients must be platinum-sensitive and have a germline or somatic BRCA mutation or an HRD mutation. Approximately 12 patients will be treated. All patients will receive the combination of AZD6738 and olaparib. Cohort D will take a lower dose of olaparib (100-200 mg daily for a 28-day cycle) and a higher dose of AZD6738 (160-320 mg daily for about 14 days). Three to five dosing schedules will be evaluated.
Drug: Olaparib Pill · Drug: AZD6738
For Cohorts A, B, and C: 300 mg twice daily by mouth which is taken continuously for 28 days, which is one cycle. Cohort D 1-2: prescribed lower dose of olaparib (100-200mg daily for a 28-day cycle). Three to five dosing schedules will be evaluated. Dose Levels 1-3: olaparib 100 mg twice daily, Days 1-28. For Dose Levels 4-5: 100-200 mg twice daily, Days 1-28. Other dose levels may be considered and will not exceed AZD6738 160mg twice daily by mouth and olaparib 150mg twice daily by mouth.
Also known as: Lynparza
For Cohorts A, B, and C: 160 mg orally once daily for first 7 days of every cycle (Days 1-7 of each 28-day cycle). Cohort D 1-2: Prescribed higher dose of AZD6738 (120-320 mg daily for about 14 days). Three to five dosing schedules will be evaluated. Dose Levels 1-3: 120-160 mg twice daily, Days 1-14, in combination with olaparib twice daily, Days 1-28. Alternatively, AZD6738 at 160 mg once daily Days 1-14 with olaparib at 100-150 mg Days 1-28 may be evaluated. Dose Levels 4-5: Alternative dosing schedule of AZD6738 at 80-160 mg once or twice daily, weekly intermittent schedule (Days 1-5, 8-12, 15-19) in combination with olaparib 100-200 mg twice daily, Days 1-28 may be evaluated. AZD6738 at 160 mg twice daily, Days 1-7 or 240 mg once daily Days 1-14 with olaparib 100-200 mg twice daily Days 1-28 may be evaluated. Other dose levels may be considered and will not exceed AZD6738 160mg twice daily by mouth and olaparib 150mg twice daily by mouth.
Incidence of Treatment-emergent Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 for all cohorts.
Time frame: 2 years
Response Rate
Objective response rate (CR+PR) of the combination of AZD6738 and olaparib in women with recurrent ovarian cancer in platinum-sensitive and resistant, and PARP inhibitor resistant cohorts (e.g. Cohorts A, B, C, and D). Response to treatment will be measured according to RECIST 1.1 criteria. Complete response will be defined as the disappearance of all target lesions. All lymph nodes must be less than 10mm in short axis. Partial response will be defined as a 30% decrease in the sum of the diameters of the target lesions. Stable disease will be defined as a change in sum of the diameters that does not meet criteria for progressive disease or partial response.
Time frame: 2 years
Maximum Tolerated Dose Response Rate
The target DLT (dose level toxicity) rate for the MTD (maximum tolerated dose) is set at 30% and two alternatives; the highest DLT rate that deemed as sub-therapeutic is 25% and the lowest DLT rate that deemed as overly toxic is 35%.
Time frame: 2 years
Progression Free Survival
Clinical anti-tumor effect by standard criteria (RECIST v 1.1) Complete response will be defined as the disappearance of all target lesions. All lymph nodes mustbe less than 10mm in short axis. Partial response will be defined as a 30% decrease in the sum of the diameters of the target lesions. Stable disease will be defined as a change in sum of the diameters that does not meet criteria for progressive disease or partial response. Progressive disease will be defined as either: * An increase in the sum of diameters of target lesions of at least 20%; * The comparison will be made to the smallest sum while the patient was on study; * The absolute increase must be at least 5mm or; * The appearance of new target lesion(s).
Time frame: 2 years
Participants were recruited based on physician referral at 3 academic medical centers between March 2018 and July 2025. The first participant was enrolled on March 9, 2018 and the last participant was enrolled July 21, 2025.
| Milestone | Cohort A | Cohort B | Cohort C | Cohort D Part I Dose Level 1 | Cohort D Part I Dose Level 1.5 | Cohort D Part I Dose Level 2 | Cohort D Part I Dose Level 4 | Cohort D Part II Dose Level 1.5 |
|---|---|---|---|---|---|---|---|---|
| Started | 37 | 14 | 14 | 3 | 3 | 6 | 8 | 12 |
| Completed | 37 | 14 | 14 | 3 | 3 | 6 | 8 | 12 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 for all cohorts.
| Participants | Cohort A | Cohort B | Cohort C | Cohort D Part I Dose Level 1 | Cohort D Part I Dose Level 1.5 | Cohort D Part I Dose Level 2 | Cohort D Part I Part Dose Level 4 | Cohort D Part II Dose Level 1.5 |
|---|---|---|---|---|---|---|---|---|
| Incidence of Treatment-emergent Adverse Events | 37 | 13 | 14 | 3 | 1 | 6 | 8 | 12 |
Objective response rate (CR+PR) of the combination of AZD6738 and olaparib in women with recurrent ovarian cancer in platinum-sensitive and resistant, and PARP inhibitor resistant cohorts (e.g. Cohorts A, B, C, and D). Response to treatment will be measured according to RECIST 1.1 criteria. Complete response will be defined as the disappearance of all target lesions. All lymph nodes must be less than 10mm in short axis. Partial response will be defined as a 30% decrease in the sum of the diameters of the target lesions. Stable disease will be defined as a change in sum of the diameters that does not meet criteria for progressive disease or partial response.
| Participants | Cohort A | Cohort B | Cohort C | Cohort D Part I Dose Level 1 | Cohort D Part I Dose Level 1.5 | Cohort D Part I Dose Level 2 | Cohort D Part I Dose Level 4 | Cohort D Part II Dose Level 1.5 |
|---|---|---|---|---|---|---|---|---|
| Response Rate | 17 | 0 | 6 | 0 | 0 | 3 | 1 | 3 |
The target DLT (dose level toxicity) rate for the MTD (maximum tolerated dose) is set at 30% and two alternatives; the highest DLT rate that deemed as sub-therapeutic is 25% and the lowest DLT rate that deemed as overly toxic is 35%.
| Participants | Cohort D Part I Dose Level 1 | Cohort D Part I Dose Level 1.5 | Cohort D Part I Dose Level 2 | Cohort D Part I Dose Level 4 |
|---|---|---|---|---|
| Maximum Tolerated Dose Response Rate | 0 | 0 | 2 | 0 |
Clinical anti-tumor effect by standard criteria (RECIST v 1.1) Complete response will be defined as the disappearance of all target lesions. All lymph nodes mustbe less than 10mm in short axis. Partial response will be defined as a 30% decrease in the sum of the diameters of the target lesions. Stable disease will be defined as a change in sum of the diameters that does not meet criteria for progressive disease or partial response. Progressive disease will be defined as either: * An increase in the sum of diameters of target lesions of at least 20%; * The comparison will be made to the smallest sum while the patient was on study; * The absolute increase must be at least 5mm or; * The appearance of new target lesion(s).
| days | Cohort A | Cohort B | Cohort C | Cohort D Part I Dose Level 1 | Cohort D Part I Dose Level 1.5 | Cohort D Part I Dose Level 2 | Cohort D Part I Dose Level 4 | Cohort D Part II Dose Level 1.5 |
|---|---|---|---|---|---|---|---|---|
| Progression Free Survival | 462 (113 to 1569) | — | 374 (155 to 652) | — | — | 213 (173 to 275) | 280 (280 to 280) | 203 (89 to 299) |
Collected over Participants were monitored/assessed from enrollment to 30 calendar days after the last dose of study drug for up to 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A | 0/37 (0%) | 6/37 (16.2%) | 37/37 (100%) |
| Cohort B | 0/14 (0%) | 1/14 (7.1%) | 14/14 (100%) |
| Cohort C | 0/14 (0%) | 1/14 (7.1%) | 14/14 (100%) |
| Cohort D Part I Dose Level 1 | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Cohort D Part I Dose Level 1.5 | 0/3 (0%) | 2/3 (66.7%) | 3/3 (100%) |
| Cohort D Part I Dose Level 2 | 0/6 (0%) | 2/6 (33.3%) | 6/6 (100%) |
| Cohort D Part I Dose Level 4 | 0/8 (0%) | 1/8 (12.5%) | 8/8 (100%) |
| Cohort D Part II Dose Level 1.5 | 0/12 (0%) | 6/12 (50%) | 12/12 (100%) |
| Event | Cohort A | Cohort B | Cohort C | Cohort D Part I Dose Level 1 | Cohort D Part I Dose Level 1.5 | Cohort D Part I Dose Level 2 | Cohort D Part I Dose Level 4 | Cohort D Part II Dose Level 1.5 |
|---|---|---|---|---|---|---|---|---|
| HypomagnesemiaMetabolism and nutrition disorders | 0/37 | 0/14 | 0/14 | 0/3 | 2/3 | 1/6 | 0/8 | 1/12 |
| Abdominal PainGastrointestinal disorders | 0/37 | 0/14 | 0/14 | 0/3 | 1/3 | 0/6 | 0/8 | 0/12 |
| Stomach PainGastrointestinal disorders | 0/37 | 0/14 | 0/14 | 0/3 | 1/3 | 0/6 | 0/8 | 1/12 |
| Platelet Count DecreasedInvestigations | 1/37 | 0/14 | 0/14 | 0/3 | 0/3 | 1/6 | 0/8 | 1/12 |
| Other, specifyVascular disorders | 0/37 | 0/14 | 0/14 | 0/3 | 0/3 | 0/6 | 1/8 | 0/12 |
| Non cardiac chest painGeneral disorders | 0/37 | 0/14 | 0/14 | 0/3 | 0/3 | 0/6 | 1/8 | 0/12 |
| Other, specifyHepatobiliary disorders | 1/37 | 0/14 | 0/14 | 0/3 | 0/3 | 0/6 | 0/8 | 1/12 |
| HyponatremiaMetabolism and nutrition disorders | 0/37 | 0/14 | 0/14 | 0/3 | 0/3 | 0/6 | 0/8 | 1/12 |
| Other, specifyNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/37 | 0/14 | 0/14 | 0/3 | 0/3 | 0/6 | 0/8 | 1/12 |
| HematomaVascular disorders | 0/37 | 0/14 | 0/14 | 0/3 | 0/3 | 0/6 | 0/8 | 1/12 |
| Event | Cohort A | Cohort B | Cohort C | Cohort D Part I Dose Level 1 | Cohort D Part I Dose Level 1.5 | Cohort D Part I Dose Level 2 | Cohort D Part I Dose Level 4 | Cohort D Part II Dose Level 1.5 |
|---|---|---|---|---|---|---|---|---|
| AnemiaBlood and lymphatic system disorders | 23/37 | 4/14 | 6/14 | 0/3 | 0/3 | 6/6 | 6/8 | 3/12 |
| FatigueGeneral disorders | 32/37 | 12/14 | 11/14 | 2/3 | 1/3 | 5/6 | 5/8 | 11/12 |
| NauseaGastrointestinal disorders | 33/37 | 10/14 | 10/14 | 2/3 | 1/3 | 3/6 | 3/8 | 4/12 |
| DizzinessNervous system disorders | 7/37 | 6/14 | 4/14 | 0/3 | 2/3 | 1/6 | 1/8 | 1/12 |
| Platelet Count DecreasedInvestigations | 9/37 | 1/14 | 7/14 | 0/3 | 0/3 | 4/6 | 2/8 | 2/12 |
| Stomach PainGastrointestinal disorders | 6/37 | 3/14 | 2/14 | 2/3 | 1/3 | 1/6 | 1/8 | 4/12 |
| DiarrheaGastrointestinal disorders | 20/37 | 2/14 | 7/14 | 0/3 | 0/3 | 3/6 | 5/8 | 1/12 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 8/37 | 6/14 | 3/14 | 1/3 | 0/3 | 2/6 | 5/8 | 2/12 |
| AnorexiaMetabolism and nutrition disorders | 10/37 | 8/14 | 6/14 | 0/3 | 0/3 | 2/6 | 1/8 | 1/12 |
| DysgeusiaNervous system disorders | 11/37 | 7/14 | 7/14 | 0/3 | 0/3 | 1/6 | 2/8 | 1/12 |
| Age, Categorical(Participants) | Cohort A | Cohort B | Cohort C | Cohort D Part I Dose Level 1 | Cohort D Part I Dose Level 1.5 | Cohort D Part I Dose Level 2 | Cohort D Part I Dose Level 4 | Cohort D Part II Dose Level 1.5 | Total |
|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 8 | 11 | 2 | 3 | 3 | 5 | 7 | 49 |
| >=65 years | 27 | 6 | 3 | 1 | 0 | 3 | 3 | 5 | 48 |
| Sex: Female, Male(Participants) | Cohort A | Cohort B | Cohort C | Cohort D Part I Dose Level 1 | Cohort D Part I Dose Level 1.5 | Cohort D Part I Dose Level 2 | Cohort D Part I Dose Level 4 | Cohort D Part II Dose Level 1.5 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 37 | 14 | 14 | 3 | 3 | 6 | 8 | 12 | 97 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Cohort A | Cohort B | Cohort C | Cohort D Part I Dose Level 1 | Cohort D Part I Dose Level 1.5 | Cohort D Part I Dose Level 2 | Cohort D Part I Dose Level 4 | Cohort D Part II Dose Level 1.5 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Caucasian/White | 34 | 12 | 10 | 3 | 2 | 6 | 7 | 10 | 84 |
| African American/Black | 2 | 2 | 1 | 0 | 1 | 0 | 1 | 0 | 7 |
| Asian | 1 | 0 | 3 | 0 | 0 | 0 | 0 | 2 | 6 |
| Native American or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hispanic Latino | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Non Hispanic Latino | 37 | 14 | 14 | 3 | 3 | 6 | 8 | 11 | 96 |
| Ethnicity Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Region of Enrollment(participants) | Cohort A | Cohort B | Cohort C | Cohort D Part I Dose Level 1 | Cohort D Part I Dose Level 1.5 | Cohort D Part I Dose Level 2 | Cohort D Part I Dose Level 4 | Cohort D Part II Dose Level 1.5 | Total |
|---|---|---|---|---|---|---|---|---|---|
| United States | 37 | 14 | 14 | 3 | 3 | 6 | 8 | 12 | 97 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Mar 2018 to primary completion in Jul 2025, 88 months.
Results were first posted in Nov 2026, 1 year 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Ceralasertib