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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. assessed until 19 sep 2016 dco (16 jan 2017 dco for china cohort); up to a maximum of 36 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. assessed until 19 sep 2016 dco (16 jan 2017 dco for china cohort); up to a maximum of 36 months. for reporting.

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 more

Trial 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
3,907 Previous Clinical Trials
5,065,769 Total Patients Enrolled
42 Trials studying Ovarian Cancer
6,600 Patients Enrolled for Ovarian Cancer
AstraZenecaLead Sponsor
4,287 Previous Clinical Trials
288,619,823 Total Patients Enrolled
48 Trials studying Ovarian Cancer
23,711 Patients Enrolled for Ovarian Cancer
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
36 Previous Clinical Trials
16,536 Total Patients Enrolled
11 Trials studying Ovarian Cancer
5,017 Patients Enrolled for Ovarian Cancer

Media Library

Olaparib 300mg tablets Clinical Trial Eligibility Overview. Trial Name: NCT01874353 — Phase 3
Ovarian Cancer Research Study Groups: Olaparib 300mg tablets, Placebo tablets
Ovarian Cancer Clinical Trial 2023: Olaparib 300mg tablets Highlights & Side Effects. Trial Name: NCT01874353 — Phase 3
Olaparib 300mg tablets 2023 Treatment Timeline for Medical Study. Trial Name: NCT01874353 — Phase 3
~28 spots leftby Jun 2025
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