A Phase 1 interventional study of Adavosertib and Cisplatin in Cervical Carcinoma, Endometrioid Adenocarcinoma and Malignant Female Reproductive System Neoplasm, sponsored by National Cancer Institute (NCI). Terminated at 8 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
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Among 80 studies testing cisplatin in Uterine Cervical Neoplasms — 10 open to participants now, 11 under way, 3 of them phase 3. Cisplatin · Uterine Cervical Neoplasms.
Among the 80 studies testing cisplatin in Uterine Cervical Neoplasms, this one is the 67th largest by enrollment of the 73 interventional ones that give a count, is one of 2 that started in 2018, is one of 18 in phase 1, and was the 68th registered.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
Browse Uterine Cervical Neoplasms studies →10 of the 80 studies testing cisplatin in Uterine Cervical Neoplasms are open now, in 6 countries. Recruiting first, the newest first:
Denise Fabian · Sites in United States
Ages 18–120 · Women only
Hospital do Coracao · Sites in Brazil
Ages 18–70 · Women only
Tata Memorial Centre · Sites in India
Ages 18–80 · Women only
Chuangzhen Chen · Sites in China
Ages 18–70 · Women only
Chongqing University Cancer Hospital · Sites in China
Ages 18–75 · Women only
By country, each count listing its studies:
Cisplatin: first FDA approval 1978 (PLATINOL-AQ). What it is approved for, and how studies give it, is on its page →
Of the 474 Uterine Cervical Neoplasms studies recruiting now, 243 (51%) set no upper age limit and 191 (40%) stop at 75 or younger; 20 take children under 18; 69 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
80 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 24 · Phase 2 34 · Phase 3 21 · Phase 4 1
First in 1996; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 10 is below the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Median enrollment 50 across the 73 interventional studies. Of the 48 that completed or were terminated, 15 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 80 has an industry lead sponsor. The 10 most frequent:
National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
70 studies in Uterine Cervical Neoplasms by National Cancer Institute (NCI): 3 open now, 12 under way, 2 of them phase 3. Of 55 finished, 29 (53%) have results posted.
Among the 70 studies in Uterine Cervical Neoplasms by National Cancer Institute (NCI), this one is the 52nd largest by enrollment of the 57 interventional ones that give a count, is one of 2 that started in 2018, is one of 17 in phase 1, and was the 56th registered.
National Cancer Institute (NCI)’s Uterine Cervical Neoplasms studies by the year they started, since 1995.
3 of the studies testing cisplatin in Uterine Cervical Neoplasms that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05764044Phase 3Hospital do CoracaoAdjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer | 2026-12-31 |
| NCT04016389University Health Network, TorontoFIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery | 2026-12 |
| NCT04491942National Cancer Institute (NCI)Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer | 2027-06-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 80 studies testing cisplatin in Uterine Cervical Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among National Cancer Institute (NCI)’s 70 in Uterine Cervical Neoplasms:
This tab as a report to print or save as PDF → With an account.
This phase I trial studies the side effects and best dose of adavosertib when given together with external beam radiation therapy and cisplatin in treating patients with cervical, vaginal, or uterine cancer. Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. External beam radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving adavosertib, external beam radiation therapy, and cisplatin may work better in treating patients with cervical, vaginal, or uterine cancer.
PRIMARY OBJECTIVE:
I. To determine the recommended phase II dose (RP2D) and safety profile of adavosertib (AZD1775) in combination with radiotherapy and concurrent cisplatin in patients with gynecological cancers.
SECONDARY OBJECTIVES:
I. To determine the acute and late toxicity of AZD1775 when administered to patients with gynecological cancer in combination with standard radiotherapy and concurrent cisplatin.
II. To evaluate the pharmacodynamic effects of AZD1775 when administered in combination with radiotherapy and concurrent cisplatin (in particular, for the 15 patients treated in an expansion cohort at the RP2D).
III. To obtain preliminary information about the progression-free survival, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or clinical progression, of AZD1775 in combination with standard radiotherapy and concurrent cisplatin in women with gynecological cancer.
OUTLINE: This is a dose-escalation study of adavosertib.
Patients undergo external beam radiation therapy on days 1-5 and receive adavosertib orally (PO) on days 1, 3, and 5 or once daily (QD) on days 1-5 and cisplatin intravenously (IV) over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.
After completion of study treatment, patients are followed up at 28 days and then every 4 months for 2 years.
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.
Patients must have one of the following proven gynecological cancer and a decision to treat with radiotherapy and concurrent cisplatin chemotherapy (RT-CT)
Newly diagnosed epithelial carcinoma of the cervix, cT1B-3B, N0/1, M0/1
Newly diagnosed epithelial carcinoma of the upper 1/3 vagina, T1-3, N0/1, M0/1
>= 9 g/dL
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 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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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 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).
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.
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 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.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
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.
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.
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.
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.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
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.
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.
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.
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.
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.
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.
Patients undergo external beam radiation therapy on days 1-5 and receive adavosertib PO on days 1, 3, and 5 or QD on days 1-5 and cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.
Drug: Adavosertib · Drug: Cisplatin · Radiation: External Beam Radiation Therapy
Given PO
Also known as: AZD-1775, AZD1775, MK-1775, MK1775
Given IV
Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin
Undergo external beam radiation therapy
Also known as: Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam Radiotherapy (conventional), External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam, Teleradiotherapy, Teletherapy, Teletherapy Radiation
Recommended Phase 2 Dose Defined as the Dose Level With < 1/6 Patients With Dose Limiting Toxicities
To determine the recommended phase II dose (RP2D) and safety profile of AZD1775 in combination with radiotherapy and concurrent cisplatin in patients with gynecological cancers.
Time frame: Up to week 5
Frequency and Severity of AZD1775 Toxicity Events in Patients With Gynecological Cancer in Combination With Standard RT and Concurrent Cisplatin
To determine the acute and late toxicity of AZD1775 when administered to patients with gynecological cancer in combination with standard radiotherapy and concurrent cisplatin. Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest. Adverse events will be summarized using all adverse events experienced, although a subanalysis may be conducted including only those adverse events in which the treating physician deems possibly, probably or definitely attributable to one or both study treatments.
Time frame: Up to 2 years
Pharmacodynamic Effects of AZD1775 in Combination With RT and Concurrent Cisplatin
To evaluate the pharmacodynamic effects of AZD1775 drugs when administered in combination with radiotherapy and concurrent cisplatin. Pharmacodynamic biomarkers will include: pCDC2, Ki67, γH2AX, pH3, and CC3. Associations between pharmacokinetic data with toxicity profiles will be performed primarily using descriptive statistics; however, logistic regression may be used if warranted.
Time frame: Up to 2 years
Progression-free Survival
To obtain preliminary information about the progression-free survival of AZD1775 in combination with radiotherapy and concurrent cisplatin in women with locally advanced gynecological cancer. Progression is defined a clinical or radiological using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years
This study was performed at 5 academic centers in the United States (four sites) and Canada (one site). It enrolled participants from May 2018 to July 2020.
| Milestone | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 |
|---|---|---|
| Started | 5 | 5 |
| Completed | 3 | 4 |
| Not completed | 2 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
To determine the recommended phase II dose (RP2D) and safety profile of AZD1775 in combination with radiotherapy and concurrent cisplatin in patients with gynecological cancers.
| Participants | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 |
|---|---|---|
| Recommended Phase 2 Dose Defined as the Dose Level With < 1/6 Patients With Dose Limiting Toxicities | NA | NA |
To determine the acute and late toxicity of AZD1775 when administered to patients with gynecological cancer in combination with standard radiotherapy and concurrent cisplatin. Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest. Adverse events will be summarized using all adverse events experienced, although a subanalysis may be conducted including only those adverse events in which the treating physician deems possibly, probably or definitely attributable to one or both study treatments.
| events | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 |
|---|---|---|
| All Grade 1-2 Toxicities | 46 | 53 |
| Related Grade 1-2 Toxicities | 37 | 36 |
| All Grade 3-4 Toxicities | 8 | 3 |
| Related Grade 3-4 Toxicities | 8 | 3 |
To evaluate the pharmacodynamic effects of AZD1775 drugs when administered in combination with radiotherapy and concurrent cisplatin. Pharmacodynamic biomarkers will include: pCDC2, Ki67, γH2AX, pH3, and CC3. Associations between pharmacokinetic data with toxicity profiles will be performed primarily using descriptive statistics; however, logistic regression may be used if warranted.
No measurements were reported for this outcome.
To obtain preliminary information about the progression-free survival of AZD1775 in combination with radiotherapy and concurrent cisplatin in women with locally advanced gynecological cancer. Progression is defined a clinical or radiological using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
| Participants | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 |
|---|---|---|
| 4 Months Post Treatment — Alive and progression-free post-treatment | 3 | 4 |
| 4 Months Post Treatment — Lost to Follow-Up | 0 | 0 |
| 2 Years Post Treatment — Alive and progression-free post-treatment | 3 | 3 |
| 2 Years Post Treatment — Lost to Follow-Up | 0 | 1 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 0/4 (0%) | 1/4 (25%) | 4/4 (100%) |
| Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 0/5 (0%) | 1/5 (20%) | 5/5 (100%) |
| Event | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 |
|---|---|---|
| Grade 3 DiarrheaGastrointestinal disorders | 1/4 | 0/5 |
| Grade 3 Lymphocyte Count DecreasedBlood and lymphatic system disorders | 0/4 | 1/5 |
| Event | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 |
|---|---|---|
| NauseaGastrointestinal disorders | 4/4 | 5/5 |
| DiarrheaGastrointestinal disorders | 3/4 | 4/5 |
| VomitingGastrointestinal disorders | 1/4 | 4/5 |
| FatigueGeneral disorders | 3/4 | 3/5 |
| HypomagnesemiaMetabolism and nutrition disorders | 3/4 | 0/5 |
| ThrombocytopeniaInvestigations | 3/4 | 0/5 |
| AnemiaBlood and lymphatic system disorders | 3/4 | 0/5 |
| AnorexiaMetabolism and nutrition disorders | 3/4 | 1/5 |
| DermatitisInjury, poisoning and procedural complications | 0/4 | 3/5 |
| Abdominal painGastrointestinal disorders | 2/4 | 1/5 |
| Age, Continuous(years) | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | Total |
|---|---|---|---|
| Median | 48 (43 to 78) | 53 (35 to 63) | 50.5 (35 to 78) |
| Sex: Female, Male(Participants) | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | Total |
|---|---|---|---|
| Female | 5 | 5 | 10 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 4 | 5 | 9 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 3 | 5 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | Total |
|---|---|---|---|
| Canada | 2 | 1 | 3 |
| United States | 3 | 4 | 7 |
| ECOG Performance Status(Participants) | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | Total |
|---|---|---|---|
| 0 | 1 | 4 | 5 |
| 1 | 4 | 1 | 5 |
| Primary Site(Participants) | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | Total |
|---|---|---|---|
| Cervical | 4 | 5 | 9 |
| Uterine | 1 | 0 | 1 |
| Prior Therapy(Participants) | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | Total |
|---|---|---|---|
| Surgery | 5 | 5 | 10 |
| Radiation | 0 | 0 | 0 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2018 to primary completion in May 2022, 47 months.
Results were first posted in Jun 2023, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Adavosertib · Cisplatin
National Cancer Institute (NCI) →