Combination ATR and PARP Inhibitor (CAPRI) Trial With AZD6738 and Olaparib in Recurrent Ovarian Cancer (CAPRI)
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|ClinicalTrials.gov Identifier: NCT03462342|
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : January 27, 2021
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 AZD 6738 and Olaparib in women with recurrent ovarian cancer in distinct Pt-sensitive and Pt-resistant cohorts.
|Condition or disease||Intervention/treatment||Phase|
|High Grade Serous Carcinoma||Drug: Olaparib Pill||Phase 2|
Women 18 years or older, who have recurrent ovarian cancer will be enrolled in this study. After consenting to participate in this trial, they will undergo screening process which will involve medical exam and blood work. If found eligible to participate in the trial, they will be given olaparib to be taken on all 28 days of the cycle and investigational AZD 6738 from days 1-7. For the first cycle, the subject will need to come in every week for lab tests and physical exam - this will help the treating physician determine an adverse event as soon as it happens. After that, patients are expected to come in every month at the end of each cycle (each cycle is 28 days).
Patients will undergo scans for tumor assessments every 2 cycles and if stable disease or response to therapy is documented after cycle 4, imaging will continue every 3 cycles thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Each cycle is 28 days. Patient will take Olaparib daily for all 28 days of the cycle and patient will take the investigational AZD6738 from days 1-7 of the cycle. Patient will visit the care provider to assess the treatment effects.|
|Masking:||None (Open Label)|
|Official Title:||Combination ATR and PARP Inhibitor (CAPRI) Trial With AZD 6738 and Olaparib in Recurrent Ovarian Cancer|
|Actual Study Start Date :||March 9, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: 1- Olaparib Pill + AZD6738.
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
For Cohorts A, B, and C:
Olaparib is prescribed at 300 mg twice daily by mouth (taken as two 150 mg tablets 12 hours apart) which is taken continuously for 28 days, which is one cycle. The tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water.
AZD6738 is prescribed at 160 mg orally once daily for first 7 days of every cycle (Days 1-7 of each 28-day cycle). You will take one 100 mg tablet and three 20mg tablets (for a total of 160mg) once daily after taking your olaparib tablets in the morning.
Cohort D: a lower dose of olaparib (100-200mg 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.
Other Name: investigational AZD6738
- Incidence of treatment-emergent adverse events [ Time Frame: 2 years ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
- Progression free survival [ Time Frame: 2 years ]Clinical anti-tumor effect by standard criteria (RECIST)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462342
|Contact: Diego Rodriguezfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins University School of Medicine||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Mary Kate Jones email@example.com|
|Principal Investigator: Stephanie L Wethington, MD|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Kim MacNeill kimberley_Macneill@dfci.harvard.edu|
|Principal Investigator: Jennifer Veneris, MD|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Diego Rodriguez 215-614-0234 firstname.lastname@example.org|
|Contact: Fiona Simpkins, MD 215-662-7336 email@example.com|
|Principal Investigator: Fiona Simpkins, MD|
|Principal Investigator:||Fiona Simpkins, MD||University of Pennsylvania|