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PARP Inhibitor

Genetic Profile-Guided Therapy for Ovarian Cancer

Phase 2

Recruiting

Led By Stephanie Lheureux, M.D.

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

Patients must have relapsed disease, either platinum-sensitive, resistant or refractory, with no limit to number of lines of prior systemic therapy

Progression on any prior Poly (ADP-ribose) polymerase (PARP) inhibitor therapy, with no limit to number of prior lines of PARP inhibitors

Must not have

Patients who have had recent (within 2 weeks of registration, or until any wound has completely healed) major thoracic or abdominal surgery prior to study start, or a surgical incision that is not fully healed

Patients with myelodysplastic syndrome/acute myeloid leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers learn if measuring biomarkers in blood and tumor tissue can help predict how well a patient will respond to PARP inhibitor treatment.

Who is the study for?

This trial is for patients with ovarian, fallopian tube, or primary peritoneal cancer who have relapsed after PARP inhibitor therapy. They must have a good heart function, measurable disease by RECIST 1.1 criteria, and proper organ function. Women of childbearing potential need to use effective contraception and not breastfeed during the study.

What is being tested?

The trial tests if using genetic markers from blood and tumor tissue can guide treatment choices post-PARP inhibitors in cancers like ovarian cancer. It involves drugs Niraparib, Dostarlimab, Bevacizumab, Paclitaxel to see which works best based on these biomarkers.

What are the potential side effects?

Potential side effects include high blood pressure from Bevacizumab; bone marrow suppression causing fatigue or infection risk from Niraparib; allergic reactions to Paclitaxel; and immune-related issues such as inflammation in organs due to Dostarlimab.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has returned after treatment, regardless of how many treatments I've had.

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My condition worsened despite previous PARP inhibitor treatments.

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I have a confirmed diagnosis of high-grade ovarian, fallopian tube, or primary peritoneal cancer.

Select...

I am able to care for myself and perform daily activities.

Select...

My cancer has worsened in the last 28 days as shown by scans.

Exclusion Criteria

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

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I have not had major chest or belly surgery in the last 2 weeks or any unhealed surgical cuts.

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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

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I don't have lasting side effects from cancer treatment worse than mild.

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My heart's electrical system has a specific irregularity.

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I do not have severe illnesses that would stop me from following the study's requirements.

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I have received PD-1 inhibitor treatment for ovarian cancer.

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I have a history of lung scarring or fibrosis.

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I have had weekly paclitaxel for recurrent ovarian cancer.

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I have not had any other major cancers besides skin cancer in the last 3 years.

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I have had a bone marrow transplant from a donor.

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I haven't had major surgery or any serious complications from one in the last 4 weeks.

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I haven't taken any experimental drugs or PARP inhibitors recently.

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I am at high risk or currently have a fistula or a digestive issue that could affect medication absorption.

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I have not had significant bleeding or coughed up a noticeable amount of blood recently.

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I am allergic to medications similar to bevacizumab, paclitaxel, dostarlimab, or niraparib.

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I have untreated brain metastases that are currently unstable.

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I have had a bowel obstruction in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424

22%

vitreous hemorrhage

17%

worsening of cataract

vitreous syneresis

posterior capsule opacification

cranial nerve VI palsy

pneumonia

pyelonephritis

colon cancer

bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab

Ozurdex

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Initial/Cohort CExperimental Treatment2 Interventions

Niraparib by mouth (orally), once a day, every day. Bevacizumab, by vein (intravenously), once every 3 weeks for up to 1 year, then every 6 weeks.

Group II: Cohort BExperimental Treatment3 Interventions

Paclitaxel, by vein (intravenously), once a week. Bevacizumab, by vein (intravenously), once every 3 weeks for up to 1 year, then every 6 weeks. Dostarlimab, by vein (intravenously), once every 3 weeks for 4 doses, then every 6 weeks afterwards.

Group III: Cohort AExperimental Treatment3 Interventions

Niraparib by mouth (orally), once a day, every day. Bevacizumab, by vein (intravenously), once every 3 weeks for up to 1 year, then every 6 weeks. Dostarlimab, by vein (intravenously), once every 3 weeks for 4 doses, then every 6 weeks afterwards.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Niraparib

2018

Completed Phase 4

~2400