Olaparib + Navitoclax for Breast Cancer

Recruiting at 2 trial locations

Overseen By Helen Mackay

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Anticoagulants, Ibuprofen

Disqualifiers: Active bleeding, Thrombocytopenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 42 days (14 days + 28 days)

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 on the Research Team?

Helen MacKay, MD

Principal Investigator

Sunnybrook Cancer Centre

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patients must have a life expectancy ≥16 weeks

I have had no more than two treatments for triple-negative breast cancer.

My triple-negative breast cancer has harmful mutations in BRCA1, BRCA2, or PALB2.

Exclusion Criteria

I haven't taken blood thinners or certain pain relievers in the last 14 days.

I haven't had major bleeding, stomach ulcers, severe esophagitis or gastritis, or blood disorders in the past year.

I haven't had cancer treatment or experimental drugs in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Olaparib is administered alone for 14 days, followed by continuous administration with escalating doses of navitoclax in 28-day cycles

42 days (14 days + 28 days)

Dose Escalation

Navitoclax dose is escalated with a fixed dose of olaparib to determine the recommended Phase II dose (RP2D)

28-day cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Navitoclax
• Olaparib

Trial Overview 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.

How Is the Trial Designed?

Group I: Single Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Princess Margaret Hospital, Canada

Collaborator

Trials

121

Recruited

40,000+

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Trials

389

Recruited

143,000+

Exactis Innovation

Collaborator

Trials

9

Recruited

10,700+