Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT04502602
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Neratinib 160 mg — DRUG
    Escalating doses to determine recommended phase 2 dose (RP2D)
  • Neratinib 200 mg — DRUG
    Determined RP2D dose
  • Neratinib 240 mg — DRUG
    Escalating doses to determine recommended phase 2 dose (RP2D)
  • Niraparib 100 mg — DRUG
    Escalating doses to determine recommended phase 2 dose (RP2D)
  • Niraparib 200 mg — DRUG
    Escalating doses to determine recommended phase 2 dose (RP2D)
  • Niraparib 300 mg — DRUG
    Phase 1: Escalating doses to determine recommended phase 2 dose (RP2D)
  • Niraparib at RP2D — DRUG
    Phase 1b: Determined dose
  • Neratinib at RP2D — DRUG
    Phase 1b: Determined dose

Study Details

To determine the recommended phase 2 dose (RP2D) of niraparib and neratinib in combination in patients with advanced solid tumors during Phase 1. To evaluate clinical benefit (≥4-month progression-free survival \[PFS\]) of niraparib and neratinib in patients with platinum-resistant ovarian cancer in Phase 1b.

Key Dates

Start date
Aug 24, 2020
Status verified
May 2026
Primary completion
Oct 30, 2024
Completion
Oct 31, 2027

Study Design

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

Arms

  • Experimental: Dose Level -1
    Neratinib 160 mg and Niraparib 100 mg by mouth once daily for 28 day cycles.
  • Experimental: Dose Level 1
    Neratinib 160 mg and Niraparib 200 mg by mouth once daily for 28 day cycles.
  • Experimental: Dose Level 2
    Neratinib 200 mg and Niraparib 200 mg by mouth once daily for 28 day cycles.
  • Experimental: Dose Level 3
    Neratinib 240 mg and Niraparib 200 mg by mouth once daily for 28 day cycles.
  • Experimental: Dose Level 4
    Neratinib 240 mg and Niraparib 300 mg by mouth once daily for 28 day cycles.
  • Experimental: Phase 1b: Platinum Resistant Expansion Cohort
    This portion of the study provides for cohort expansion to observe for 4 month or greater progression-free survival in patients with platinum resistant ovarian cancer treated at the recommended phase 2 dose (RP2D) determined in Phase I.

Primary Outcome Measure

Phase 1: To determine the Recommended phase 2 dose (RP2D) of niraparib and neratinib in patients with advanced solid tumors [ Time Frame: 4 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298-

Find similar trials in Richmond, VA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Virginia Commonwealth University· Richmond, VA

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