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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My cancer has returned after treatment, regardless of how many treatments I've had.
Select...
My condition worsened despite previous PARP inhibitor treatments.
Select...
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.
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My cancer has worsened in the last 28 days as shown by scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants that achieve biomarker-guided treatment
Response rate percentage
Secondary outcome measures
CA125 response rate for Cohort A
CA125 response rate for Cohort B
CA125 response rate for initial cohort/Cohort C
+12 moreSide effects data
From 2015 Phase 4 trial • 45 Patients • NCT0203642422%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex
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
Niraparib
2018
Completed Phase 4
~1540
Dostarlimab
2020
Completed Phase 2
~1000
Bevacizumab
2013
Completed Phase 4
~5280
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,471 Previous Clinical Trials
484,930 Total Patients Enrolled
14 Trials studying Ovarian Cancer
3,443 Patients Enrolled for Ovarian Cancer
GlaxoSmithKlineIndustry Sponsor
4,751 Previous Clinical Trials
8,067,432 Total Patients Enrolled
23 Trials studying Ovarian Cancer
16,410 Patients Enrolled for Ovarian Cancer
Stephanie Lheureux, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
4 Previous Clinical Trials
186 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree not to donate blood during and for 3 months after the study.My cancer has returned after treatment, regardless of how many treatments I've had.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.My condition worsened despite previous PARP inhibitor treatments.My blood, kidney, and liver tests are all within normal ranges.I have a confirmed diagnosis of high-grade ovarian, fallopian tube, or primary peritoneal cancer.I am willing to use effective birth control and can provide a negative pregnancy test before starting therapy.My heart's pumping ability is good, confirmed by a recent heart scan.I am able to care for myself and perform daily activities.I have not had major chest or belly surgery in the last 2 weeks or any unhealed surgical cuts.I don't have lasting side effects from cancer treatment worse than mild.My heart's electrical system has a specific irregularity.I do not have severe illnesses that would stop me from following the study's requirements.You have a tumor that can be measured using specific guidelines for evaluating cancer.I have received PD-1 inhibitor treatment for ovarian cancer.I have an autoimmune disease treated with medication in the last 2 years.I have a history of lung scarring or fibrosis.I am not on any cancer treatment except for a PARP inhibitor.My cancer has worsened in the last 28 days as shown by scans.I have tissue samples from before my PARP inhibitor treatment.I have had a stroke or a mini-stroke in the last six months.I have had weekly paclitaxel for recurrent ovarian cancer.I have not had any other major cancers besides skin cancer in the last 3 years.You have a weakened immune system due to conditions like HIV or active hepatitis B or C.My blood pressure is higher than 140/90 mmHg, even with medication.I have had a bone marrow transplant from a donor.I haven't had major surgery or any serious complications from one in the last 4 weeks.I haven't taken any experimental drugs or PARP inhibitors recently.I am at high risk or currently have a fistula or a digestive issue that could affect medication absorption.I have not had significant bleeding or coughed up a noticeable amount of blood recently.I am allergic to medications similar to bevacizumab, paclitaxel, dostarlimab, or niraparib.I am willing to have a tumor biopsy before treatment.I have untreated brain metastases that are currently unstable.You have high levels of protein in your urine on two separate tests within 14 days.I have had a bowel obstruction in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Initial/Cohort C
- Group 2: Cohort A
- Group 3: Cohort B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what ways is Bevacizumab ordinarily applied?
"The medication Bevacizumab is prescribed to manage recurrent platinum-sensitive epithelial ovarian cancer, malignant tumours, and persistent cervical neoplasms."
Answered by AI
What perils have been linked to Bevacizumab usage?
"Our team at Power presents bevacizumab with a 2 on the safety scale due to evidence-based research which has established its relative security, yet no available proof of effectiveness."
Answered by AI
Could you elucidate on previous researches involving Bevacizumab?
"Currently, this biologic agent is being studied for various medical applications in 1228 live clinical trials with 303 of them reaching Phase 3. Of the 59975 sites running studies on Bevacizumab, several are based in Shanghai."
Answered by AI
How many participants are projected to take part in this scientific investigation?
"This research project is not currently enrolling participants. Initially posted on June 6th 2022 and last updated May 2nd 2022, if you are looking for alternative trials there are presently 693 clinical trials recruiting patients with malignant neoplasms and 1,228 active studies that use Bevacizumab as a treatment."
Answered by AI
Is there currently an opportunity to join this research endeavor?
"The clinicaltrial.gov website reports that this trial is not actively seeking participants, despite the fact it was initially posted on June 6th 2022 and last updated on May 2nd 2022. Fortunately, there are over 1,900 other medical trials accepting applications from potential candidates."
Answered by AI
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