Your session is about to expire
← Back to Search
Bcl-2/Bcl-XL Inhibitor
Olaparib + Navitoclax for Breast Cancer
Phase 1
Recruiting
Led By Helen MacKay, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No more than two (2) prior lines of treatment for TNBC
Metastatic TNBC with known deleterious somatic or germline mutations in BRCA1, BRCA2, or PALB2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trialwill test if combining an inhibitor of Bcl-2/Bcl-XL with an inhibitor of PARP in people with certain BRCA1/2 or PALB2 mutations can be safely used to treat certain types of breast cancer.
Who is the study for?
This trial is for women over 18 with certain types of advanced ovarian or breast cancer (HGSC, TNBC) who have specific genetic mutations (BRCA1/2, PALB2). They should not have had more than two treatments for TNBC and must be able to take oral medications. Women must not be pregnant and should have a life expectancy of at least 16 weeks.Check my eligibility
What is being tested?
The study tests combining Olaparib, a PARP inhibitor, with Navitoclax, which blocks proteins that prevent cell death in cancers like HGSC and TNBC. It aims to find the safest dose combination for future Phase II trials by observing side effects and determining the maximum tolerated dose.See study design
What are the potential side effects?
Possible side effects include nausea, fatigue, anemia (low red blood cells), risk of bleeding or bruising due to low platelets, gastrointestinal issues affecting absorption of the drugs, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had no more than two treatments for triple-negative breast cancer.
Select...
My triple-negative breast cancer has harmful mutations in BRCA1, BRCA2, or PALB2.
Select...
I am 18 years old or older.
Select...
I can swallow pills and don't have stomach issues affecting medicine absorption.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To define a dose and schedule of navitoclax (Recommended Phase II Dose, RP2D) that can be combined safely with Olaparib in women with metastatic recurrent high grade serous ovarian cancer (HGSC) and triple negative breast cancer (TNBC) for further study
Secondary outcome measures
Cmax: the maximum drug concentration.
Tmax: time to reach the maximum drug concentration.
Trial Design
1Treatment groups
Experimental Treatment
Group I: SingleExperimental Treatment2 Interventions
Olaparib tablet will be administered alone for 14 days at a starting dose of 200 mg twice daily (bid). Subsequently olaparib will be administered continuously over 28 days at a fixed dose and the dose of navitoclax will be escalated. Navitoclax will be administered daily. The initial dose of olaparib 200 mg has been selected after considering the single agent Phase I/II dose based and on ongoing combination studies on expected toxicity and evidence for reduced PARP inhibition
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Navitoclax
2012
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
Princess Margaret Hospital, CanadaOTHER
119 Previous Clinical Trials
39,023 Total Patients Enrolled
2 Trials studying Ovarian Cancer
800 Patients Enrolled for Ovarian Cancer
Centre hospitalier de l'Université de Montréal (CHUM)OTHER
366 Previous Clinical Trials
129,601 Total Patients Enrolled
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,272 Total Patients Enrolled
2 Trials studying Ovarian Cancer
240 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had no more than two treatments for triple-negative breast cancer.I haven't taken blood thinners or certain pain relievers in the last 14 days.My triple-negative breast cancer has harmful mutations in BRCA1, BRCA2, or PALB2.I've had PARP inhibitor treatment but my condition didn't worsen within 6 months after stopping it.I have had any number of treatments for high-grade serous ovarian cancer.I haven't had major bleeding, stomach ulcers, severe esophagitis or gastritis, or blood disorders in the past year.My cancer has returned, is spreading, and it's been over 6 months since my last platinum treatment.I am deemed fit to undergo treatment with olaparib according to this study's guidelines.Patients must have a way to measure their disease according to RECIST 1.1.My organ and bone marrow function are within healthy ranges as tested within the last 28 days.I haven't had cancer treatment or experimental drugs in the last 30 days.I am 18 years old or older.I've been mostly active and able to care for myself within the last week.I can swallow pills and don't have stomach issues affecting medicine absorption.
Research Study Groups:
This trial has the following groups:- Group 1: Single
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.
Has the FDA sanctioned Single as a viable treatment?
"The team at Power evaluated the safety of Single to be a 1 on a scale from 1 to 3, since it is currently in Phase 1 and there is limited evidence for both safety and efficacy."
Answered by AI
Can people still enroll in this medical experiment?
"Affirmative, according to clinicaltrials.gov the trial is still recruiting and has been since November 9th 2022 when it was first uploaded. The most recent update occurred on November 28th of the same year, looking for 36 subjects between 3 distinct sites."
Answered by AI
What is the sample size for this experimental investigation?
"Affirmative. According to clinicaltrials.gov, this research initiative was first made available on November 9th 2022 and has since been updated in late November of the same year. 36 participants are required from 3 sites for successful completion of the trial."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger