Suspended

Fruquintinib for Refractory Metastatic Colorectal Cancer in Expanded Access Program

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Study Aim

This study aims to provide access to Fruquintinib for individuals with refractory metastatic colorectal cancer, observing its effects and responses in this specific patient population.

What is being tested

Data Collection

Who is eligible

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is it accessible

Suspended

Available upon a request by a licensed MD
Expanded Access
See protocol details

Summary

Principal SponsorTakeda
Last updated: January 31, 2026
Sourced from a government-validated database.Claim as a partner

The study focuses on a drug called TAK-113, also known as Fruquintinib, for patients with metastatic colorectal cancer who have not responded to standard therapy. This program aims to provide early access to TAK-113 for eligible individuals who cannot be adequately treated by current standards and cannot participate in a clinical trial. The goal is to offer a potential treatment option until it becomes commercially available in their respective countries. This study is important as it addresses an unmet need for patients with refractory metastatic colorectal cancer, potentially improving their care and treatment outcomes. All participants in the study will receive TAK-113 in the form of 5 mg oral capsules, following a schedule of three weeks on and one week off for each four-week cycle. The study also includes a voluntary, non-interventional collection of real-world data as part of the expanded access program. Participants will continue with the treatment until their disease progresses, they experience unacceptable toxicity, they withdraw their consent, the treatment becomes commercially available, or the product development is halted.

Official TitleExpanded Access Program: Fruquintinib for Patients With Metastatic Colorectal Cancer Who Progressed After Standard Therapy
NCT06195514
Principal SponsorTakeda
Last updated: January 31, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms

Criteria

5 inclusion criteria required to participate
Eastern Cooperative Oncology Group (ECOG) physical status of 0-2.
Histologically and/or cytologically documented metastatic colorectal adenocarcinoma.
Received all locally available and appropriate prior standard therapies and no other satisfactory treatment option is available for this condition. Participants may have received either prior TAS-102 or regorafenib. Must have progressed on or intolerant to fluoropyrimidine-, oxaliplatin-, and irinotecan- based chemotherapies, anti-vascular endothelial growth factor (VEGF) therapy, and, if rat sarcoma (RAS) wild-type, an anti- epidermal growth factor receptor (EGFR) therapy if available locally for this condition.
Adequate bone marrow and organ function as defined by the following: Absolute neutrophil count of ≥1.5×10^9 per liter, platelet count of ≥75×10^9 per liter, and hemoglobin ≥8 grams per deciliter (g/dL). Serum total bilirubin ≤1.5 times the upper limit of normal (ULN). Urine dipstick ≤1+ for proteinuria or ≤30 milligrams per deciliter (mg/dL) in urinalysis, unless quantitative protein is <1000 milligram (mg) in a 24-hour urine sample or urine protein: creatinine ratio on spot urine testing is ≤1.9. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase levels ≤2.5 times the ULN (participants with liver metastases must have ALT and AST levels ≤5 times the ULN). Serum creatinine ≤1.5 times the ULN or creatinine clearance ≥60 milliliters per minute (mL/min).
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5 exclusion criteria prevent from participating
Any unresolved toxicities from a previous antitumor treatment greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 grade 1 (except for alopecia or neurotoxicity grade≤2).
Received systemic anticancer therapies [including chemotherapy, tyrosine-kinase inhibitors (TKIs) and endocrine therapy] within 2 weeks prior to the first dose of study drug. NOTE: If participant is currently receiving TAK-113 outside of a clinical trial and benefitting from treatment, they may still be considered provided they meet all other criteria.
Major surgery within the last 60 days or have had any other minor surgery or invasive procedure within the last 4 weeks.
Any thromboembolic events (including deep vein thrombosis, and pulmonary embolism) within the past 6 months, or history of stroke and/or transient ischemic attack within the last 12 months.
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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SuspendedNo study centers