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Bcl-2/Bcl-XL Inhibitor
Olaparib + Navitoclax for Breast Cancer
Phase 1
Waitlist Available
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
No Placebo-Only Group
Summary
This trial tests a combination of two drugs, olaparib and navitoclax, in women with specific genetic mutations in aggressive breast and ovarian cancers. Olaparib weakens the cancer cells, and navitoclax helps kill them. The goal is to find a safe and effective dose for future studies. Olaparib has been approved for use in patients with advanced ovarian 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.
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.
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.
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My triple-negative breast cancer has harmful mutations in BRCA1, BRCA2, or PALB2.
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I am 18 years old or older.
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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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Cmax: the maximum drug concentration.
Tmax: time to reach the maximum drug concentration.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2015
Completed Phase 2
~150
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
PARP inhibitors, such as Olaparib, work by blocking the PARP enzyme, which is crucial for repairing single-strand DNA breaks. In cancer cells with BRCA1/2 mutations, this leads to the accumulation of DNA damage and ultimately cell death, a concept known as synthetic lethality.
Bcl-2/Bcl-XL inhibitors like Navitoclax promote cancer cell death by inhibiting proteins that prevent apoptosis, the programmed cell death process. Combining these treatments can enhance the effectiveness of inducing cancer cell death, offering a promising approach for patients with ovarian cancer, particularly those with specific genetic mutations.
Systematic Review of Olaparib in the Treatment of Recurrent Platinum Sensitive Ovarian Cancer.PARP Inhibition Elicits STING-Dependent Antitumor Immunity in Brca1-Deficient Ovarian Cancer.
Systematic Review of Olaparib in the Treatment of Recurrent Platinum Sensitive Ovarian Cancer.PARP Inhibition Elicits STING-Dependent Antitumor Immunity in Brca1-Deficient Ovarian Cancer.
Find a Location
Who is running the clinical trial?
Princess Margaret Hospital, CanadaOTHER
120 Previous Clinical Trials
39,916 Total Patients Enrolled
12 Trials studying Breast Cancer
22,847 Patients Enrolled for Breast Cancer
Centre hospitalier de l'Université de Montréal (CHUM)OTHER
380 Previous Clinical Trials
131,553 Total Patients Enrolled
5 Trials studying Breast Cancer
784 Patients Enrolled for Breast Cancer
Sunnybrook Health Sciences CentreLead Sponsor
681 Previous Clinical Trials
1,565,722 Total Patients Enrolled
33 Trials studying Breast Cancer
17,172 Patients Enrolled for Breast Cancer
Exactis InnovationOTHER
8 Previous Clinical Trials
10,648 Total Patients Enrolled
1 Trials studying Breast Cancer
130 Patients Enrolled for Breast Cancer
Helen MacKay, MDPrincipal InvestigatorSunnybrook Cancer Centre
2 Previous Clinical Trials
9 Total Patients Enrolled
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.