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HDM201 and Pazopanib in Patients With P53 Wild-type Advanced/Metastatic Soft Tissue Sarcomas

Study acronym: AMPHISARC
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Re-verified, no change to tracked fieldsv7
  2. Primary completion date: Jan 2026 to Feb 2027v6 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 58 to confirmed 47
    • Study completion date: Jul 2026 to Feb 2027
    • Site details revised at 5 of 5 sites
  3. Primary completion date: Jan 2025 to Jan 2026
    • Study completion date: Jul 2025 to Jul 2026
    • Eligibility criteria expanded, about 136 words
    v5
  4. Site details revised at 2 of 5 sitesv4
  5. Study sites revised (5)v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2022 to Apr 15, 2022
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Centre Leon Berard
70 trials monitored
See 2 trials at risk
Sarcoma
1,026 trials monitored
See 67 trials at risk
This trial is a two-step Phase I/II study comprising: Part 1: A dose escalation part with the aim to assess the safety of the proposed combination (N= up to 30 patients). In the dose escalation part, eligible patients will be treated with a fixed dose of pazopanib and escalating doses of HDM201. Part 2: An extension part to collect preliminary data about the clinical activity of the proposed combination according to the 6M-PFR.
Trial Details
NCT Number NCT05180695
Lead Sponsor Centre Leon Berard
Collaborators: Novartis, National Cancer Institute, France
Conditions
(from sponsor)		 Advanced Soft-tissue Sarcoma, Metastatic Soft-tissue Sarcoma
Related terms Sarcoma
Enrollment 47 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov