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Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jun 2026 → Jun 2027
See other at-risk trials from Fox Chase Cancer Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 2026 to Jun 2027
    • Study completion pushed from Jun 2027 to Jun 2028
    • Eligibility criteria expanded, about 9 words
    • Study description revised
  2. Primary completion date: Jun 2025 to Jun 2026v9
  3. Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description expanded, about 301 words
    • Site details revised at 2 of 3 sites
    v8
  4. Trial status: Suspended to Recruiting
    • Site details revised at 3 of 3 sites
    v7
  5. Trial status: Recruiting to Suspended Sponsor's reason: Pending cohort review meeting
    • Site details revised at 3 of 3 sites
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Jun 2024 to Jun 2025
    • Study sites: 1 to 3
    • Study completion date: Jun 2026 to Jun 2027
    v5
  2. Trial status: Suspended to Recruiting
    • Site details revised
    v4
  3. Trial status: Not Yet Recruiting to Suspended Sponsor's reason: Waiting on lab kits for correlative studies
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2022 to Jun 24, 2022
    v3
  4. Lead sponsor: Namrata Vijayvergia to Fox Chase Cancer Centerv2 Show 4 more changesShow less
    • Start date: Apr 2022 to Jun 2022
    • Primary completion date: Feb 2024 to Jun 2024
    • Study completion date: Feb 2026 to Jun 2026
    • Collaborators expanded, about 7 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is Phase 1 dose finding trial with potential dose expansion to evaluate the safety, toxicity, recommended phase 2 dose (RP2D), and maximum tolerated dose (MTD) of Neratinib plus TDxD using a standard 3+3 dose escalation design in patients with metastatic or unresectable gastro-esophageal cancer that are HER2-overexpressing (IHC 3+ or IHC2+/ISH+) and any other gastrointestinal cancer with HER2 expression with IHC3+. Patients must have progressed or been intolerant of at least one prior line of chemotherapy + HER2 directed therapy.
Trial Details
NCT Number NCT05274048
Lead Sponsor Fox Chase Cancer Center
Collaborators: National Comprehensive Cancer Network, Puma Biotechnology, Inc.
Conditions
(from sponsor)		 Gastric Cancer, Gastrointestinal Cancer, HER2 Gene Mutation
Related terms Gastrointestinal Neoplasms, Stomach Neoplasms
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov