Access to TAK-113 for Adults with Advanced Colorectal Cancer

Sponsor: Takeda

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06195514

Provider View

This program offers access to TAK-113, a treatment not yet approved, for adults with advanced colorectal cancer who have no other treatment options and cannot join a clinical trial.

Patient Parameters

Program Overview

This program allows adults with advanced colorectal cancer, who have not responded to standard treatments and cannot join a clinical trial, to access TAK-113. Participants will receive TAK-113 until it becomes available in their country or until it no longer benefits them.

Description

This program provides early access to TAK-113 for adults with advanced colorectal cancer who have exhausted other treatment options and cannot join a clinical trial. Participants will take TAK-113 in the form of 5 mg oral capsules, following a schedule of three weeks on and one week off, in four-week cycles. The program includes optional data collection to understand real-world use. Participants will continue treatment until their cancer progresses, they experience unacceptable side effects, they choose to stop, the drug becomes available commercially, or the drug's development is halted. This is an international program involving multiple centers.

Eligibility Criteria

Inclusion Criteria

  • Have a physical status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a confirmed diagnosis of metastatic colorectal cancer.
  • Have tried all available standard treatments without success, including specific chemotherapy and targeted therapies.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1.5 billion per liter.
    • Platelet count of at least 75 billion per liter.
    • Hemoglobin level of at least 8 g/dL.
    • Normal liver and kidney function as indicated by specific blood tests.
  • Cannot join other clinical trials for advanced colorectal cancer.

Exclusion Criteria

  • Have received cancer treatments, including chemotherapy or targeted therapies, within two weeks before starting TAK-113.
  • Have uncontrolled high blood pressure.
  • Have unresolved side effects from previous cancer treatments, except for mild hair loss or nerve damage.
  • Have had major surgery in the last 60 days or minor surgery in the last four weeks.
  • Have had blood clots, such as deep vein thrombosis or pulmonary embolism, in the last six months, or a stroke in the last year.

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