← Back to Search

Alkylating Agent

Olaparib + Chemotherapy for Advanced Ovarian Cancer

Phase 2

Waitlist Available

Led By Amit Oza, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with serous ovarian cancer

Patients who have received no more than 3 previous platinum containing treatments and were progression free for at least 6 months following the end of the last platinum treatment

Must not have

Hypersensitivity to pre medications required for treatment with paclitaxel/carboplatin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether adding olaparib to standard chemotherapy (carboplatin and paclitaxel) is more effective in treating advanced ovarian cancer than chemotherapy alone.

Who is the study for?

This trial is for patients with advanced ovarian cancer who have had no more than three prior platinum treatments and were progression-free for at least six months after the last one. They must have at least one measurable lesion and be diagnosed with serous ovarian cancer. Those with recent chemotherapy, radiotherapy, or hypersensitivity to related medications cannot participate.

What is being tested?

The study compares the effectiveness of Olaparib combined with Carboplatin and Paclitaxel versus just Carboplatin and Paclitaxel in treating advanced ovarian cancer. The goal is to see if adding Olaparib improves patient outcomes.

What are the potential side effects?

Olaparib may cause nausea, fatigue, blood cell count issues, respiratory problems, gastrointestinal symptoms, and potential allergic reactions. Carboplatin can lead to kidney problems, hearing damage, nerve issues while Paclitaxel might cause joint pain and hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with serous ovarian cancer.

Select...

I've had up to 3 platinum treatments and was stable for 6+ months after.

Exclusion Criteria

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

Select...

I am allergic to the medications given before paclitaxel/carboplatin treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months) 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)

Secondary study objectives

Overall Survival (OS)

Percentage Change in Tumour Size

Side effects data

From 2023 Phase 3 trial • 387 Patients • NCT02987543

43%

Anaemia

43%

Nausea

30%

Decreased appetite

27%

Fatigue

21%

Diarrhoea

19%

Constipation

19%

Vomiting

14%

Asthenia

14%

Back pain

13%

Oedema peripheral

11%

Cough

10%

Arthralgia

Dyspnoea

Dyspepsia

Weight decreased

Dysgeusia

Thrombocytopenia

Musculoskeletal pain

Dizziness

Urinary tract infection

Headache

Pyrexia

Neutropenia

Musculoskeletal chest pain

Lymphopenia

Insomnia

Stomatitis

Pain in extremity

Pneumonia

Haematuria

Pulmonary embolism

Sepsis

Femur fracture

Hyponatraemia

Muscular weakness

Pneumonia aspiration

Pneumothorax

Cardiopulmonary failure

Urinary retention

Bone pain

Cerebrovascular accident

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A+B Olaparib 300mg bd

Cohort A+B Investigators Choice of NHA

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 1Experimental Treatment3 Interventions

Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions.

Group II: 2Active Control2 Interventions

paclitaxel iv and carboplatin iv

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

paclitaxel

1996

Completed Phase 3

~4310

olaparib

2009