LCI-BRE-MTN-NIR-001:Ph I Study of Niraparib in Combo With Standard Chemo in Metastatic Trip Neg Breast Cancer

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04762901
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Niraparib — DRUG
    Oral tablet
  • Doxorubicin — DRUG
    IV
  • Cyclophosphamide — DRUG
    IV
  • Paclitaxel — DRUG
    IV
  • Pegfilgrastim — DRUG
    Injection
  • Carboplatin — DRUG
    IV

Study Details

This is an open-label, two-stage, multi-arm Phase 1 study designed to evaluate the safety and preliminary efficacy of combining niraparib with four standard chemotherapy regimens used to treat TNBC.

Key Dates

Start date
Apr 1, 2021
Status verified
May 2021
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

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

Arms

  • Experimental: Stage 1 Arm 1
    Niraparib 100 mg orally once daily, Doxorubicin and Cyclophosphamide (AC) IV every 14 days with pegfilgrastim (or biosimilar) for 4 cycles, followed by AC IV every 21 days
  • Experimental: Stage 1 Arm 2
    Niraparib 100 mg orally once daily, Doxorubicin and Cyclophosphamide (AC) IV every 21 days
  • Experimental: Stage 1 Arm 3
    Niraparib 100 mg orally once daily, Paclitaxel IV Days 1, 8, 15, and 22 every 28 days
  • Experimental: Stage 1 Arm 4
    Niraparib 100 mg orally once daily, Paclitaxel IV Days 1, 8, and 15 every 21 days and carboplatin IV every 21 days
  • Experimental: Stage 2 Arm 1
    Niraparib 100 mg orally once daily, Doxorubicin and Cyclophosphamide (AC) IV every 14 days with pegfilgrastim (or biosimilar) for 4 cycles
  • Experimental: Stage 2 Arm 2
    Niraparib 100 mg orally once daily, Doxorubicin and Cyclophosphamide (AC) IV every 21 days

Primary Outcome Measure

Stage 1 - Evaluate dose-limiting toxicities (DLT) separately for Arms 1, 2, 3, and 4 and establish recommended Stage 2 dose of chemotherapy in combination with niraparib [ Time Frame: up to 28 days ]

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