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Angiogenesis Inhibitor
Durvalumab + Olaparib + Cediranib for Ovarian Cancer
Phase 1 & 2
Recruiting
Led By Jung-Min Lee, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have adequately controlled blood pressure on a maximum of three antihypertensive medications
Patients must have metastatic, progressive, castrate resistant prostate cancer (mCRPC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 days 1 and 15; cycles 2 and beyond day 1
Awards & highlights
Study Summary
This trial is testing the combination of Durvalumab, Olaparib, and Cediranib in adults with advanced or recurrent ovarian cancer to see how well they tolerate it and if it is effective in treating the cancer.
Who is the study for?
Adults with certain advanced cancers (ovarian, triple negative breast, lung, prostate and colorectal) that have progressed despite previous treatments. Participants must be over 18 years old with controlled blood pressure and no history of autoimmune diseases requiring steroids or primary immunodeficiency. They should not have had prior treatment with the drugs being tested in this trial or other similar immune therapies.Check my eligibility
What is being tested?
The study is testing a combination of Durvalumab (an immune system booster), Olaparib (a DNA damage inhibitor), and Cediranib (a drug that halts blood vessel growth in cancer cells). The Phase I part checks for safety and tolerability while Phase II assesses effectiveness against ovarian cancer specifically.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, high blood pressure from Cediranib, fatigue, nausea from Olaparib, as well as risks associated with taking Durvalumab such as infusion reactions. Regular monitoring through visits and diaries will help manage these.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood pressure is under control with up to three medications.
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My prostate cancer has spread and is not responding to hormone therapy.
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My ovarian, fallopian tube, or peritoneal cancer has come back or didn't respond to treatment, including at least two prior treatments or resistance to platinum-based therapy.
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My breast cancer is triple-negative and has come back or not gone away.
Select...
I have advanced NSCLC and received platinum-based chemo or specific inhibitors due to my tumor's genetic features.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1 days 1 and 15; cycles 2 and beyond day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 days 1 and 15; cycles 2 and beyond day 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ph I Determine the recommended phase II dose (RP2D) and the safety of doublet therapies of Durvalumab/olaparib (Durvalumab-O) and Durvalumab/cediranib (Durvalumab-C) in patients with advanced solid tumors
Ph II Determine overall response rate of Durvalumab-O and Durvalumab-C in patients with recurrent ovarian cancer
Secondary outcome measures
Therapeutic procedure
Ph I doublet tx: determine the safety of the doublets, Durvalumab+O and Durvalumab+C
Ph I doublet tx: explore changes in peripheral immune subsets, plasma cytokines and circulating endothelial cells with safety and/or clinical outcome of Durvalumab+C
+12 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: P2 Durvalumab+O+CExperimental Treatment3 Interventions
Ph II Durvalumab + olaparib + cediranib at RP2D
Group II: P2 Durvalumab+OExperimental Treatment2 Interventions
Ph II Durvalumab + olaparib at RP2D
Group III: P2 Durvalumab+CExperimental Treatment2 Interventions
Ph II Durvalumab + cediranib at RP2D
Group IV: P1 Durvalumab+O+CExperimental Treatment3 Interventions
Ph I Durvalumab + olaparib + cediranib dose escalation
Group V: P1 Durvalumab+OExperimental Treatment2 Interventions
Ph I Durvalumab + olaparib dose escalation
Group VI: P1 Durvalumab+CExperimental Treatment2 Interventions
Ph I Durvalumab + cediranib dose escalation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140
Cediranib
2016
Completed Phase 3
~4030
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,470 Total Patients Enrolled
Jung-Min Lee, M.D.Principal InvestigatorNational Cancer Institute (NCI)
6 Previous Clinical Trials
856 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with PARP inhibitors.My blood pressure is under control with up to three medications.I have previously received treatments like MEDI4736 or other therapies targeting PD1, PD-L1, or CTLA4.My prostate cancer has spread and is not responding to hormone therapy.I have had a stroke or a mini-stroke in the last year.I have had pneumonitis or interstitial lung disease before.I haven't had radionuclide treatment in the last 6 weeks.I have been diagnosed with tuberculosis in the past.I have had brain metastasis or leptomeningeal disease in the last year.I have had heart problems in the last year.I have been treated with both olaparib and cediranib.My ovarian, fallopian tube, or peritoneal cancer has come back or didn't respond to treatment, including at least two prior treatments or resistance to platinum-based therapy.My breast cancer is triple-negative and has come back or not gone away.I have an autoimmune disease and need steroids to manage it, or I have a primary immunodeficiency.I have advanced NSCLC and received platinum-based chemo or specific inhibitors due to my tumor's genetic features.I have had other types of cancer besides the one I am seeking treatment for.I am HIV-positive and currently on antiretroviral therapy.You have hepatitis B or C.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: P2 Durvalumab+O
- Group 2: P2 Durvalumab+C
- Group 3: P2 Durvalumab+O+C
- Group 4: P1 Durvalumab+O+C
- Group 5: P1 Durvalumab+O
- Group 6: P1 Durvalumab+C
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.
What investigations have been conducted to evaluate the efficacy of Olaparib?
"Currently, 489 clinical trials for Olaparib are active with 75 in phase 3. Houston, Texas hosts many of these studies while a total of 20211 locations across the globe have research initiatives involving Olaparib."
Answered by AI
What is the primary purpose of Olaparib in a therapeutic setting?
"Olaparib is generally used to treat diseases; however, this medication has also been effectively utilized as a pharmacotherapeutic agent for primary peritoneal cancer and advanced directives."
Answered by AI
What goals is this clinical examination hoping to achieve?
"This clinical trial aims to evaluate the recommended phase 2 dose and safety of a combination therapy involving MEDI4736/olaparib (MEDI-O) and MEDI4736/cediranib (MEDI-C). Secondary objectives include determining preliminary response rates, overall response rate along with adverse events, duration of response and PSA responses for Phase II Cohort 4 mCRPC; Durvalumab+O arm, as well as progression free survival, safety by CTCAE v4.0 in Phase II Cohort 5 TNBC; MEDI+O arm. Additionally, this study will investigate any"
Answered by AI
Is this an innovative research study?
"Olaparib has been investigated since 2005 and a first trial was conducted under the auspices of AstraZeneca that year. After its Phase 1 drug approval, 489 trials related to Olaparib can be found in 65 countries across 1856 cities worldwide."
Answered by AI
Are enrollment opportunities still available for this clinical trial?
"Data hosted on clinicaltrials.gov confirms that this medical study, which was initially posted on June 29th 2015, is actively recruiting potential candidates."
Answered by AI
How many participants are taking part in this research endeavor?
"Affirmative. According to clinicaltrials.gov, this research is still seeking participants; it was posted on June 29th 2015 and recently updated on October 31st 2022 . A total of 384 patients from 2 locations must be recruited for the study."
Answered by AI
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