Olaparib + Sapacitabine in BRCA Mutant Breast Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03641755
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sapacitabine — DRUG
    Sapacitabine may help to stop the growth of some types of cancers
  • Olaparib — DRUG
    Olaparib is an inhibitor of PARP (poly \[adenosine diphosphate-ribose\] polymerase), which means that it stops PARP from working

Study Details

This research study is studying a combination of drugs as a possible treatment for breast cancer with a BRCA mutation. The interventions involved in this study are: * Sapacitabine (CYC682) * Olaparib (Lynparza™)

Key Dates

Start date
Oct 1, 2018
Status verified
Jan 2026
Primary completion
Apr 27, 2022
Completion
Oct 22, 2026

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level -1: Sapacitabine (100 mg) + Olaparib (300 mg)
    * Olaparib will be administered orally twice daily for each 28-day cycle * Sapacitabine will be administered orally once daily on days 1 - 5 and 8 - 12 of every 28-day cycle
  • Experimental: Dose Level 1: Sapacitabine (150 mg) + Olaparib (300 mg)
    * Olaparib will be administered orally twice daily for each 28-day cycle * Sapacitabine will be administered orally once daily on days 1 - 5 and 8 - 12 of every 28-day cycle
  • Experimental: Dose Level 2: Sapacitabine (200 mg) + Olaparib (300 mg)
    * Olaparib will be administered orally twice daily for each 28-day cycle * Sapacitabine will be administered orally once daily on days 1 - 5 and 8 - 12 of every 28-day cycle
  • Experimental: Dose Level 3: Sapacitabine (250 mg) + Olaparib (300 mg)
    * Olaparib will be administered orally twice daily for each 28-day cycle * Sapacitabine will be administered orally once daily on days 1 - 5 and 8 - 12 of every 28-day cycle

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Assessed from the time of the first patient registration to the time that the last patient comes off protocol therapy in the dose escalation phase, up to 41 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
Broad Institute of MITCambridgeMassachusetts02142-

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Dana Farber Cancer Institute· Boston, MABroad Institute of MIT· Cambridge, MA

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