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

First listed
Aug 22, 2018
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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