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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
MedPacto, Inc.
Study ID
NCT05588648
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Osteosarcoma

Eligibility Criteria

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

Interventions

  • Vactosertib — DRUG
    Vactosertib is given twice a day, five days on and two days off in four-week cycles. Vactosertib is a transforming growth factor-beta (TGF-β) type 1 receptor inhibitor.

Study Details

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.

Key Dates

Start date
May 1, 2023
Status verified
Apr 2025
Primary completion
Sep 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Single arm, open-label, no blinding or randomization procedure will be involved.

Primary Outcome Measure

Dose finding associated with the overall nature and severity of AEs associated with treatment. [ Time Frame: Assessment of adverse events and laboratory abnormalities. through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UH Rainbow Babies & Children's HospitalClevelandOhio44106
Kristen VanHeyst, DO
[email protected]
(216) 844-3345
Kristen VanHeyst, DO (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By research site
UH Rainbow Babies & Children's Hospital· Cleveland, OH

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