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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

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

Study 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.Check my eligibility

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.See study design

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

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I have been diagnosed with serous ovarian cancer.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS)

Secondary outcome measures

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

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

Completed Phase 3

~690

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,259 Previous Clinical Trials

288,593,740 Total Patients Enrolled

47 Trials studying Ovarian Cancer

23,688 Patients Enrolled for Ovarian Cancer

Amit Oza, MDPrincipal InvestigatorPrincess Margaret Hospital, Canada

4 Previous Clinical Trials

724 Total Patients Enrolled

1 Trials studying Ovarian Cancer

44 Patients Enrolled for Ovarian Cancer

Jane Robertson, BSc, MBCHB, MDStudy DirectorAstraZeneca

11 Previous Clinical Trials

1,304 Total Patients Enrolled

Media Library

Carboplatin (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01081951 — Phase 2

Ovarian Cancer Research Study Groups: 2, 1

Ovarian Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT01081951 — Phase 2

Carboplatin (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01081951 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has olaparib attained regulatory consent from the FDA?

"There is evidence of olaparib's safety, but not yet efficacy, so its rating on the Power scale was a 2."

Answered by AI

How many establishments are currently conducting the clinical trial across North America?

"This clinical research is taking place at 12 distinct facilities, ranging from Sherbrooke and Vancouver to Stanford. To simplify your participation if you decide to join the trial, make sure to pick the location closest to you."

Answered by AI

How many people have enrolled in the trial thus far?

"This clinical trial has ceased its recruitment process. Initially posted on February 12th 2010 and last edited October 4th 2022, there are currently 677 trials that accept ovarian cancer patients, and 1326 involving olaparib actively recruiting new participants."

Answered by AI

Are there currently opportunities for individuals to take part in this medical trial?

"The present recruitment for this medical trial has been completed. This study was first posted on February 12th 2010 and underwent a revision dated October 4th 2022. In case you are seeking out other clinical trials, 677 studies recruiting participants with ovarian cancer remain active alongside 1326 olaparib-related investigations accepting enrolment."

Answered by AI

Are there any antecedent studies involving olaparib?

"A full two decades ago, the City of Hope Comprehensive Cancer Center first initiated research into olaparib. Since then, 1610 trials have been completed and an additional 1326 are still ongoing in a variety of locations including Sherbrooke, Quebec."

Answered by AI

Is this trial open to participants of advanced age?

"According to the prerequisites for enrolment into this trial, participants must be between 18 and 125 years old."

Answered by AI

What are the primary applications of olaparib in therapeutic treatment?

"For treating esophageal neoplasms malignant, olaparib is often prescribed. Additionally, this therapy can be beneficial for those receiving palliative care and suffering from advanced endometrial cancer or malignant peritoneal neoplasm."

Answered by AI