Study on the Safety and Effectiveness of Vactosertib for Adolescents and Adults with Difficult-to-Treat Osteosarcoma

Sponsor: MedPacto, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05588648

Provider View

This clinical trial is testing a new drug called Vactosertib to see if it is safe and effective for treating osteosarcoma, a type of bone cancer, in patients aged 14 and older whose cancer has returned, not responded to treatment, or is getting worse.

Patient Parameters

Program Overview

This study is designed to test the safety and effectiveness of a new drug, Vactosertib, in adolescents and adults with osteosarcoma that has come back, not responded to treatment, or is getting worse. Vactosertib is taken by mouth twice a day by patients who are 14 years or older and meet the study's requirements. The study is divided into two phases: Phase I will determine the safest dose, and Phase II will evaluate how well the drug works at that dose.

Description

This clinical trial is divided into two phases to test Vactosertib, a new drug for treating osteosarcoma, a type of bone cancer.

In Phase I, the study will find the safest dose of Vactosertib by gradually increasing the dose given to patients and monitoring for any side effects. At least six patients will be enrolled to find the maximum dose that can be safely tolerated.

In Phase II, the study will enroll 42 patients to test how well Vactosertib works at the determined safe dose. This phase will look at how the drug affects the cancer and the overall response rate of patients.

Vactosertib is taken by mouth twice a day, five days a week, with a two-day break, in a four-week cycle. The study will monitor the drug's effects on the body and any changes in the cancer.

Participants must be 14 years or older and have a confirmed diagnosis of osteosarcoma that has not responded to previous treatments. They must also meet specific health criteria, including adequate organ function and recovery from previous treatments. The study will require participants to take the medication with food and attend regular follow-up visits to monitor their health and the drug's effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 14 years or older.
  • Have a confirmed diagnosis of osteosarcoma.
  • Cancer must be measurable and have not responded to previous treatments.
  • Must have recovered from previous treatment side effects, except for hair loss, appetite loss, bone pain, and tumor pain.
  • Must have adequate kidney function and no active infections.
  • Must have a performance status score indicating they are able to carry out daily activities.
  • Must have normal organ and bone marrow function, including specific blood cell counts and liver function tests.
  • Must be able to understand and sign a consent form if 18 or older, or an assent form if younger.
  • Must weigh more than 30 kg.

Exclusion Criteria

  • Have moderate or severe heart disease.
  • Have uncontrolled health issues, such as infections, heart failure, high blood pressure, or mental health conditions that could affect participation.
  • Have major abnormalities in heart tests.
  • Have a history of heart or aorta surgery.
  • Have significant gastrointestinal bleeding recently.
  • Have allergies to the study drug or its ingredients.
  • Have used certain medications that affect the study drug.
  • Are unable to swallow tablets.
  • Have a history of drug abuse.
  • Are pregnant or unable to use effective birth control.
  • Are considered unsuitable for the study by the investigator.
  • Have participated in another study recently.
  • Are taking prohibited medications.
  • Have severe allergies to Vactosertib.
  • Have conditions that could interfere with the study results.
  • Are HIV-positive and on antiretroviral therapy.

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