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

Colorectal Cancer Clinical Trial

Official title: Expanded Access Program: Fruquintinib for Patients With Metastatic Colorectal Cancer Who Progressed After Standard Therapy

Status Available

Clinical Trial 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.

Clinical Trial Description

This is an expanded access program in which the drug being given is called TAK-113. This study will provide early access to TAK-113 until commercial availability in the respective country, for eligible participants with refractory mCRC who cannot adequately be treated by current standard of care and who cannot enter a clinical trial. All participants will receive TAK-113 5 mg oral capsules in a 3 weeks on/1 week off schedule for each 4-week cycle. As a part of the expanded access program, there will be a voluntary non-interventional real-world data collection of information. This is a multi-center international program. Participants will continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, the treatment becomes commercially available, or halting of product development. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT06195514
• Study type: Expanded Access
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS@takeda.com
• Status: Available