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

Study acronym: iNNOVATE
StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date changed from estimate of Aug 27, 2026 to Oct 30, 2024
    • Study completion date: May 31, 2029 to Oct 31, 2027
    v13
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 45 to confirmed 18
    • Site details revised
    v12
  3. Site contact updatedv11
  4. Primary completion date: Aug 27, 2024 to Aug 27, 2026v10
  5. Primary completion date changed from estimate of May 31, 2024 to Aug 27, 2024v9
Show 7 earlier versionsHide 7 earlier versions
  1. Re-verified, no change to tracked fieldsv8
  2. Eligibility criteria expanded, about 10 wordsv7
  3. Eligibility criteria revisedv6
  4. Eligibility criteria revised
    • Site contact updated
    v5
  5. Eligibility criteria expanded, about 23 wordsv4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 30, 2020 to Aug 24, 2020
    • Site details revised
    v3
  7. Collaborators: 1 to 2v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04502602
Lead Sponsor Virginia Commonwealth University
Collaborators: Puma Biotechnology, Inc., GlaxoSmithKline
Conditions
(from sponsor)		 Advanced Solid Tumor, Ovarian Cancer
Related terms Ovarian Neoplasms
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov