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Olaparib for Ovarian Cancer
Phase 3
Waitlist Available
Led By Professor E Pujade-Lauraine, MD, PhD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be ≥ 18 years of age.
Patient must have received a platinum based chemotherapy regimen (e.g. carboplatin or cisplatin) and have received at least 4 cycles of treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pharmacokinetics sampling to be performed in a subset of patients. sampling times: day 1 pre-dose & 1 hour; day 15 pre-dose & 1 hour; day 29 pre-dose. assessed until 19 sep 2016 dco.
Awards & highlights
Study Summary
This trial is testing a new cancer treatment in patients who have responded to standard platinum-based chemotherapy.
Who is the study for?
This trial is for women over 18 with high-grade serous ovarian cancer or endometrioid cancer, who have a harmful BRCA mutation. They should have had at least two platinum-based chemotherapies and be in partial or complete response to the last one without CA-125 increase. They can't join if they've been involved in study planning/conduct or have non-detrimental BRCA mutations.Check my eligibility
What is being tested?
The study tests Olaparib tablets (300mg) against a placebo in patients with certain types of ovarian cancer who responded to previous chemotherapy. It's a Phase III trial where participants are randomly assigned to either the drug or placebo, and neither they nor the doctors know which one they're getting.See study design
What are the potential side effects?
While not specified here, common side effects of Olaparib may include nausea, fatigue, anemia, low blood cell counts leading to increased infection risk, vomiting, diarrhea, loss of appetite and taste changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have completed at least 4 cycles of platinum-based chemotherapy.
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I am a woman with a specific type of ovarian, peritoneal, or fallopian tube cancer that has come back.
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I have a harmful BRCA1 or BRCA2 mutation.
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I have had at least 2 treatments with platinum-based drugs before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ scans at baseline then every 12 wks for 72 wks, then every 24 wks until first progression. assessments then per local practice every 12 wks until second progression. assessed until 19sep2016 dco (16jan2017 dco for china cohort); up to a max of 36 mths
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~scans at baseline then every 12 wks for 72 wks, then every 24 wks until first progression. assessments then per local practice every 12 wks until second progression. assessed until 19sep2016 dco (16jan2017 dco for china cohort); up to a max of 36 mths
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)
Secondary outcome measures
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
Pharmacotherapy
Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Olaparib 300mg tabletsExperimental Treatment1 Intervention
Taken orally twice daily
Group II: Placebo tabletsPlacebo Group1 Intervention
Taken orally twice daily
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Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,244 Total Patients Enrolled
42 Trials studying Ovarian Cancer
6,600 Patients Enrolled for Ovarian Cancer
AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,459 Total Patients Enrolled
48 Trials studying Ovarian Cancer
23,850 Patients Enrolled for Ovarian Cancer
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
35 Previous Clinical Trials
16,312 Total Patients Enrolled
10 Trials studying Ovarian Cancer
4,791 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I had fluid drained from my abdomen during my last two chemotherapy cycles.I have had at least 2 treatments with platinum-based drugs before.I have a harmful BRCA1 or BRCA2 mutation.I finished my chemotherapy less than 8 weeks ago.My cancer is responding to treatment or I have no signs of cancer after surgery and chemotherapy.I have completed at least 4 cycles of platinum-based chemotherapy.I am a woman with a specific type of ovarian, peritoneal, or fallopian tube cancer that has come back.My cancer returned more than 6 months after my last platinum chemotherapy.My BRCA1 or BRCA2 mutation is not considered harmful.I am on maintenance therapy after my second-to-last platinum-based treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Olaparib 300mg tablets
- Group 2: Placebo tablets
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 conditions is Olaparib 300mg tablets meant to treat?
"Olaparib 300mg tablets can be used to treat primary peritoneal cancer, malignant neoplasm of ovary, and other conditions as specified in advance directives."
Answered by AI
Which type of person is eligible to join this clinical trial?
"This clinical trial is looking for 327 participants who have ovarian cancer and meet the following criteria: they must be between 18 and 130 years old, female, have a documented mutation in BRCA1 or BRCA2, have received at least 2 previous lines of platinum-containing therapy, be in response (partial or complete radiological response) or may have no evidence of disease, and have received a platinum-based chemotherapy regimen. Maintenance treatment is allowed."
Answered by AI
Is the age limit for participants in this research younger than seventy years old?
"The age range for this study starts at 18 years old and goes up to 130 years old."
Answered by AI
Are there any other similar cases in which Olaparib 300mg tablets have been used?
"Currently, there are 26 Olaparib 300mg tablet trials in Phase 3 out of the 195 active clinical trials. Most of these studies are based in Houston, Texas, but Olaparib 300mg tablet trials are running in 8903 locations globally."
Answered by AI
Can you tell me how many research centers are conducting this experiment?
"In total, there are 26 enrolment centres for this clinical trial. They are located in London, Quebec, Toronto, California, Sherbrooke, Colorado, as well as 23 other states."
Answered by AI
Did the FDA clear Olaparib 300mg tablets for public use?
"This medication has been studied in clinical trials and shown to be effective in treating certain conditions. Additionally, there is data supporting its safety, so it received a score of 3."
Answered by AI
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