Study on CA-4948 as a Single Treatment for Patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Sponsor: Curis, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04278768

Provider View

This clinical trial is testing a new drug, CA-4948, to see if it is safe and effective for treating adults with certain types of blood cancers, specifically AML and higher-risk MDS. The study involves taking the drug by mouth and is divided into two phases to find the best dose and to see how well it works.

Patient Parameters

Program Overview

This study is exploring the use of a new oral medication, CA-4948, for adults with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The trial is divided into two parts: Phase 1, which aims to find the safest dose, and Phase 2a, which looks at how well the drug works in shrinking cancer. Participants will take the medication in cycles of 28 days, and the study will monitor their health and any side effects. The goal is to determine the best dose that balances effectiveness and safety.

Description

The study is testing a new drug called CA-4948, taken as a pill, to treat adults with certain blood cancers like AML and high-risk MDS. The trial is in two parts: Phase 1 focuses on finding the safest dose, while Phase 2a looks at how well the drug works in treating the cancer. Participants will take the drug in 28-day cycles, and the study will monitor their health and any side effects. The aim is to find a dose that is both effective and safe.

In Phase 1, the study will determine the maximum dose that patients can tolerate without severe side effects. In Phase 2a, the study will assess the drug's ability to reduce cancer in patients with specific genetic mutations. The drug is taken twice daily, and participants can continue treatment as long as it is beneficial and side effects are manageable.

The study will also explore how the drug interacts with the body and its effects on cancer cells. Participants will be closely monitored for any adverse reactions, and the study will adjust doses as needed to ensure safety. The ultimate goal is to find a dose that provides the most benefit with the least risk of side effects.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older.
  • Life expectancy of at least 3 months.
  • Good overall health, able to perform daily activities with minimal assistance.
  • Diagnosed with AML or high-risk MDS that has not responded to previous treatments.
  • Acceptable organ function based on medical tests.
  • Able to swallow pills.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 90 days after.
  • Men must agree to use effective birth control if their partner is a woman of childbearing potential.
  • Willing to provide informed consent and follow study procedures.
  • Able to undergo blood and bone marrow tests as required by the study.

Exclusion Criteria

  • Diagnosed with a specific type of leukemia called acute promyelocytic leukemia (APL).
  • Active leukemia in the central nervous system.
  • Recent stem cell transplant or significant complications from a transplant.
  • Diagnosed with chronic myeloid leukemia (CML).
  • Recent cancer treatments or investigational drugs within a specified time before starting the study.
  • Unresolved side effects from previous cancer treatments.
  • Known allergy to the study drug.
  • Recent major surgery.
  • Active advanced solid tumors.
  • HIV positive or have certain viral infections unless controlled.
  • Uncontrolled heart disease or other serious medical conditions.
  • Gastrointestinal issues that affect drug absorption.
  • Pregnant or breastfeeding.
  • Active infections that are not controlled.
  • Any other condition that may increase the risk of participating in the study.

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