Study to Assess Safety and Efficacy of Vactosertib in Adolescents and Adults With Recurrent, Refractory or Progressive Osteosarcoma

StatusRecruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years 2 months later Sep 2025 → Dec 2027
See other at-risk trials from MedPacto, Inc.

Record History

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  1. Primary completion pushed from Sep 2025 to Dec 2027 Show 6 more changesShow less
    • Enrollment increased: 48 → 78 participants
    • Trial sites expanded: 3 → 7 locations
    • Study completion pushed from Dec 2025 to Feb 2028
    • Eligibility criteria expanded, about 90 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
  2. Site contacts updated at 3 of 3 sitesv7
  3. Start date: Mar 31, 2023 to May 1, 2023v6 Show 5 more changesShow less
    • Study sites: 6 to 3
    • Primary completion date: Jul 2025 to Sep 2025
    • Study completion date: Nov 2025 to Dec 2025
    • Eligibility criteria expanded, about 88 words
    • Study description shortened, about 142 words
  4. Study sites: 4 to 6v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 4
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Feb 2023 to Mar 31, 2023
    • Study sites: 0 to 1
    v3
  2. Start date: Jan 2023 to Feb 2023
    • Study title expanded, about 4 words
    v2
  1. Study First Submitted
  • 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.
MedPacto, Inc.
2 trials monitored
See 1 trial at risk
Sarcoma
1,027 trials monitored
See 70 trials at risk
MP-VAC-209 is a Phase I/II, open label, single arm, multi-center study to assess safety, tolerability, and antitumor activity of vactosertib as a single agent in adolescents and adults with recurrent, refractory, or progressive osteosarcoma. Vactosertib is given orally, twice a day, to people 12 years of age and older who meet the criteria for study enrollment.
Trial Details
NCT Number NCT05588648
Lead Sponsor MedPacto, Inc.
Conditions
(from sponsor)		 Osteosarcoma
Related terms Osteosarcoma
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov