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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients in Module 2 Part B2 Study expansion must have advanced gastric adenocarcinoma (including GEJ) with ATM proficient tumours
Patients in Module 2 Part B4 Study expansion must have Second or third line triple negative breast cancer (TNBC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose to confirmed progressive disease (approximately 1 year)
Awards & highlights
Study Summary
This trial is testing the safety of a new drug, ceralasertib, when used in combination with other cancer treatments. The goal is to find the best dose of ceralasertib to use with other treatments.
Who is the study for?
This trial is for adults with advanced cancers, including specific types of lung, breast, ovarian cancer and other solid tumors. Eligibility varies by module: some require certain genetic mutations or prior treatments. Exclusions include previous ATR inhibitor exposure, contraindications to study drugs like olaparib and durvalumab, diabetes (in Module 4), and bad reactions to ceralasertib.Check my eligibility
What is being tested?
The trial tests ascending doses of ceralasertib alone or in combination with chemotherapy agents like carboplatin or novel anti-cancer agents such as olaparib and durvalumab. It aims to find the optimal dose combinations while monitoring safety closely. Effects on food absorption and ECG parameters are also studied.See study design
What are the potential side effects?
Potential side effects may include typical reactions from chemotherapy such as nausea, fatigue, blood count changes; immune-related issues from durvalumab; allergic reactions; plus any unique effects related to ceralasertib which could involve gastrointestinal symptoms or impact on liver function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced stomach cancer is ATM proficient.
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My breast cancer is triple negative and I am seeking second or third line treatment.
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My advanced stomach cancer lacks the ATM protein.
Select...
I am 18 years old or older.
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My solid tumor cannot be treated with standard methods anymore.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose to confirmed progressive disease (approximately 1 year)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to confirmed progressive disease (approximately 1 year)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Module 4 only: Effect of ceralasertib on ECG parameters (HR, PR, QRS and QTcF) by ECG recordings
Module 4 only: Effect of food on ceralasertib absorption by Intensive PK assessments after a single oral dose of ceralasertib (Part A)
The number of subjects with adverse events/serious adverse events
Secondary outcome measures
Area under the plasma concentration-time curve (AUC) for Carboplatin
Area under the plasma concentration-time curve (AUC) for Olaparib
Area under the plasma concentration-time curve (AUC) for ceralasertib
+26 moreTrial Design
14Treatment groups
Experimental Treatment
Group I: Module 5 Part BExperimental Treatment1 Intervention
Module 5 Part B: cohort expansions of ceralasertib in combination with AZD5305 in ovarian patients at dose, frequency and schedule from Module 5 Part A.
Group II: Module 5 Part AExperimental Treatment1 Intervention
Module 5 Part A: ascending doses of ceralasertib will be administered in combination with AZD5305 to patients to define the MTD, RP2D.
In case this first dose level is not tolerated, alternative schedules will be evaluated.
Group III: Module 4 (FE/QT)Experimental Treatment3 Interventions
Ceralasertib monotherapy will be administered on a number of days during Cycle 0 to assess the effect of food on ceralasertib absorption and effect of ceralasertib on ECG parameters under various conditions (fasted, fed, steady state). From C1 onwards, patients who participated in C0 will be allocated to either ceralasertib in combination with olaparib or durvalumab, or ceralasertib monotherapy and assessed for safety.
Group IV: Module 3 Part BExperimental Treatment1 Intervention
Module 3 Part B: cohort expansions of ceralasertib in combination with durvalumab in HNSCC or NSCLC patients at dose, frequency and schedule from Module 3 Part A.
Group V: Module 3 Part AExperimental Treatment1 Intervention
Module 3 Part A: cohort escalation of ceralasertib in combination with durvalumab in HNSCC or NSCLC patients to define the dose, frequency and schedule of ceralasertib and durvalumab to take into Module 3 Part B. Additionally, Module 3 Part A will include a serial tumour biopsy cohort to evaluate the Proof of Mechanism of ceralasertib in HNSCC and NSCLC patients.
Group VI: Module 2 Part B5Experimental Treatment1 Intervention
Patients with BRCA mutant or RAD51C/D mutant (either germline or somatic) or HRD-positive status epithelial ovarian, fallopian tube, or primary peritoneal cancer according to local testing. Patients must be platinum sensitive and previously progressed on a licensed PARPi. The cohort will be split into 2 groups: Cohort 1 - without intervening chemotherapy following progression on a PARPi, Cohort 2 - with intervening chemotherapy following progression on a PARPi. Patients will receive ceralasertib and olaparib, at the RP2D dose, frequency and schedule established from Module 2 Part A2.
Group VII: Module 2 Part B4Experimental Treatment1 Intervention
Module Part B4: Patients with second or third line triple negative breast cancer with no known BRCA mutations. This expansion will be enriched for patients with disease harbouring a HRR-related gene mutation (HRRm) will receive ceralasertib with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Group VIII: Module 2 Part B3Experimental Treatment1 Intervention
Module 2 Part B3: Patient with second or third line breast cancer with BRCA mutations (somatic or germline), excluding HER2 positive breast cancer will receive ceralasertib with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Group IX: Module 2 Part B2Experimental Treatment1 Intervention
Module 2 part B2: Patients with second line 'ATM proficient' gastric adenocarcinoma including GEJ adenocarcinoma will receive ceralasertib with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Group X: Module 2 Part B1Experimental Treatment1 Intervention
Module 2 Part B1: Patients with second line 'ATM deficient' gastric adenocarcinoma including GEJ adenocarcinoma will receive ceralasertib with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Group XI: Module 2 Part A2Experimental Treatment1 Intervention
Module 2 Part A2: ascending doses of ceralasertib will be administered in combination with olaparib to patients to define the dose, frequency and schedule of ceralasertib and olaparib to take into Module 2 Part B.
Group XII: Module 2 Part A1Experimental Treatment1 Intervention
Module 2 Part A1: ascending doses of ceralasertib will be administered alone to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD) to take into Module 2 Part A2.
Group XIII: Module 1 Part BExperimental Treatment1 Intervention
Module 1 Part B: patients with advanced lung adenocarcinoma with low expression of ATM will receive ceralasertib and carboplatin, at the dose, frequency and schedule recommended from Module 1 Part A.
Group XIV: Module 1 Part AExperimental Treatment1 Intervention
Module 1 Part A: ascending doses of ceralasertib in combination with carboplatin AUC5 will be administered to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD).
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,612,237 Total Patients Enrolled
3 Trials studying Solid Malignancies
229 Patients Enrolled for Solid Malignancies
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My advanced stomach cancer is ATM proficient.My breast cancer is triple negative and I am seeking second or third line treatment.My tumor is at least 1 cm big and can be seen on a CT or MRI scan.My ovarian cancer is sensitive to platinum, has specific genetic mutations, and I've previously not responded well to PARPi treatment.I cannot receive durvalumab due to health reasons.I have type I or type II diabetes.I am allergic to PARP inhibitors, including AZD5305.I have been treated with an ATR inhibitor before.I have advanced lung cancer or head and neck cancer that has come back or spread.I have ovarian, fallopian tube, or peritoneal cancer, previously treated with a PARP inhibitor and my cancer responded well to platinum-based therapy.I cannot take olaparib due to health reasons.My advanced stomach cancer lacks the ATM protein.I have a BRCA, PALB2, RAD51C/D mutation or am HRD positive.I am 18 years old or older.My heart's electrical activity (QTc) is over 470 msec or I have a family history of long QT syndrome.I have been diagnosed with ataxia telangiectasia.My solid tumor cannot be treated with standard methods anymore.My breast cancer is HER2 negative and I am seeking second or third line treatment.I have an advanced solid tumor but not in my stomach, esophagus, or colorectal area without small bowel surgery.You had a negative reaction to ceralasertib.
Research Study Groups:
This trial has the following groups:- Group 1: Module 2 Part B3
- Group 2: Module 1 Part B
- Group 3: Module 3 Part B
- Group 4: Module 3 Part A
- Group 5: Module 2 Part B4
- Group 6: Module 2 Part B5
- Group 7: Module 2 Part B2
- Group 8: Module 2 Part A1
- Group 9: Module 2 Part A2
- Group 10: Module 2 Part B1
- Group 11: Module 4 (FE/QT)
- Group 12: Module 5 Part A
- Group 13: Module 5 Part B
- Group 14: Module 1 Part A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it feasible for those over 65 to partake in this study?
"This research project is enlisting adults aged 18 and younger or below 130 years of age."
Answered by AI
How many medical facilities are currently conducting this clinical investigation?
"At present, 5 medical centres are running this clinical trial - those in Newport Beach, Los Angeles and New york City as well as a further five other sites. Participants should consider selecting the closest location to them so they don't have to travel vast distances."
Answered by AI
Is enrollment currently open for participation in this experiment?
"Affirmative. Clinicaltrials.gov indicates that this clinical trial, initially published on October 31 2014, is actively recruiting participants. In total, 330 patients are being recruited from 5 medical sites for the study."
Answered by AI
What is the sample size that this trial is aiming to recruit?
"Affirmative, clinicaltrials.gov records that this trial is now recruiting. The first posting was on October 31st 2014 and the most recent edit happened on September 20th 2022. To meet their goal of 330 participants, 5 medical centres are enrolling patients."
Answered by AI
What therapeutic applications is ceralasertib most frequently utilized for?
"Ceralasertib is commonly administered to patients who have gone through chemotherapy, as well as those suffering from advanced thymoma, testicular cancer, carcinoma and neuroendocrine."
Answered by AI
What prior trials have been conducted to assess the efficacy of ceralasertib?
"The initial testing of ceralasertib was done at Bristol Royal Hospital for Children back in 2002, with 995 studies now completed. At present, 1114 trials are ongoing; many taking place near Newport Beach, California."
Answered by AI
May I have the opportunity to enroll in this research study?
"This clinical trial is open to 330 people aged 18-130 suffering from breast cancer who meet the following parameters: Module 1 and 2 Part B study expansions, tumours that can be measured using CT/MRI scans of at least 1 cm in size, no other standard treatments suitable for their condition (Module 3), second line lung adenocarcinoma with ATM deficient tumors (Module 1 Part B Study Expansion), advanced gastric adenocarcinoma patients with either ATM proficient or deficient tumors (Module 2 Part B1 & B2 Study Expansions respectively) ,second or third line HER2 negative and triple negative breast cancers"
Answered by AI
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