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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

Must not have

Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study.

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

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had fluid drained from my abdomen during my last two chemotherapy cycles.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)

Secondary study objectives

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

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