Study on Revumenib for Patients with Colorectal Cancer and Other Solid Tumors

Sponsor: Syndax Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05731947

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, revumenib, in adults with colorectal cancer or other solid tumors who have not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how safe and effective the drug revumenib is for treating colorectal cancer and other solid tumors in adults who have already tried at least one other treatment. The study will be conducted in two phases. In Phase 1, researchers will test different doses of revumenib to find the safest and most effective amount. In Phase 2, they will further investigate how well the drug works in shrinking tumors.

Description

The study is divided into two parts. In Phase 1, researchers will test different doses of revumenib to find the safest and most effective amount. This phase will also look for early signs that the drug is working against tumors. In Phase 2, the study will focus on confirming these early results and further evaluating the drug's ability to shrink tumors in patients with colorectal cancer and other solid tumors.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Have colorectal cancer or another type of solid tumor that has spread or come back after treatment.
  • Have had at least one standard treatment for colorectal cancer and cannot take or did not respond to certain drugs like oxaliplatin, irinotecan, and bevacizumab.
  • For other solid tumors, have tried all available standard treatments unless they were not suitable or caused severe side effects.
  • Have evidence of cancer that has returned or spread, confirmed by scans within 28 days before starting the study.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • If previously treated with radiation, must have a 2-week break before starting the study and still have at least one measurable tumor.
  • Have not received immunotherapy or certain other treatments for at least 42 days before starting the study.
  • Have adequate bone marrow, kidney, heart, and liver function as shown by specific medical tests.

Exclusion Criteria

  • Have had a bowel blockage requiring hospitalization in the past 6 months.
  • Have uncontrolled fluid buildup in the abdomen needing frequent drainage in the past 3 months.
  • Have a detectable HIV viral load in the past 6 months.
  • Have hepatitis B or C.
  • Have had a heart attack, unstable chest pain, heart failure, severe heart rhythm problems, or stroke in the past 6 months.
  • Have a prolonged QT interval on an ECG (greater than 450 milliseconds).
  • Have gastrointestinal issues that affect drug absorption, like gastric bypass or slow stomach emptying.
  • Have severe liver disease (Child-Pugh score B or C).
  • Have brain metastases unless treated and stable for at least 4 weeks without steroids.
  • Have any condition or allergy that might interfere with the study or not be in the participant's best interest.
  • Have received chemotherapy, targeted therapy, or radiation within 2 weeks before starting the study and not recovered from side effects.
  • Have participated in another clinical trial with an investigational drug within 30 days before starting revumenib.
  • Have received a blood transfusion or growth factors within 4 weeks before the first dose of the study drug.
  • Have had another cancer in the past 5 years, except for certain skin cancers or early-stage cervical or breast cancer.

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