A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer

Part of paid clinical trials in New York, New York.

Sponsor
AstraZeneca
Study ID
NCT02561832
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    tablets taken orally twice daily
  • Carboplatin — DRUG
    intravenous injections on day one of each cycle
  • Anthracycline — DRUG
    The choice of anthracycline and cyclophosphamide (AC) regimen in Part B will be up to local Investigator following international guidelines
  • Cyclophosphamide — DRUG
    The choice of anthracycline and cyclophosphamide (AC) regimen in Part B will be up to local Investigator following international guidelines

Study Details

This is an open-label study to assess the safety, tolerability and efficacy of olaparib in combination with carboplatin. There are two parts in this study: Part A, a dose escalation in patients with advanced Human Epidermal Growth Factor 2 (HER-2) negative breast cancer and Part B, a dose expansion in the neoadjuvant treatment of HER-2 negative breast cancer patients with germline Breast Cancer Susceptibility Gene (BRCA)1/2 mutations.

Key Dates

Start date
Nov 6, 2015
Status verified
Oct 2018
Primary completion
Sep 30, 2016
Completion
Feb 1, 2017

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Part A: ascending doses of olaparib in combination with carboplatin will be administered to investigate safety and tolerability and to define the MTD and/or RD for part B. Patients will be treated with this combination up to cycle 4, after cycle 4 they can continue with combination or monotherapy (carboplatin or olaparib). Cohorts will be started sequentially, based on SRC recommendation. Part B will start after MTD/RD identification in part A. Patients will receive olaparib and carboplatin combination for first 4 cycles (21 days per cycle), at the dose, frequency and schedule recommended from Part A. This will be followed by another 4 cycles of standard cancer therapy consisting of anthracycline and cyclophosphamide regimen. Total of 8 treatment cycles will be given before final surgery

Primary Outcome Measure

Part A: Number of Subjects Reporting Adverse Events (AEs) [ Time Frame: From day 1 cycle 1, up to and including 30 days after last dose ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteNew YorkNew York10065-
Research SiteStony BrookNew York11794-

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Research Site· New York, NYResearch Site· Stony Brook, NY

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