Expanded Access to TAK-113 for Adults With Metastatic Colorectal Cancer (mCRC)

NCT06195514 | Unknown

• 1 other identifier: TAK-113 EAP
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The expanded access program allows people to gain access to an unlicensed treatment on compassionate grounds. This expanded access program provides adults with refractory metastatic colorectal cancer (mCRC) and who cannot neither adequately be treated by current standard of care nor participate in a clinical study access to TAK-113 until TAK-113 becomes commercially available in the respective country or the adult does no longer seem to benefit from treatment with TAK-113.

Conditions

Colorectal Cancer

Keywords

Drug Therapy

Interventions

TAK-113 DRUG

Description: TAK-113 5 mg capsules, orally, once daily, in a 3 weeks on/1 week off schedule for each 4-week cycle per treatment guidelines.

Also known as: Fruquintinib, HMPL-013

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Ineligible for other clinical trials of investigational drugs for refractory mCRC, if available.

You may not qualify if:

• 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.
• Uncontrolled hypertension as defined per local institution.
• 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).
• 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.

Sponsors & Collaborators

• Takeda: lead

Related Links

• To obtain more information on the study, click this link.

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

HMPL-013

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Last Updated: January 30, 2026

Record last verified: 2026-01