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fruquintinib · 1 trial · 4 indications
Progression-Free Survival (PFS) rate at 6 months, defined as the percentage of participants at 6 months who have not experienced disease progression as defined by the RECIST Version 1.1 criteria or death on study. Participants who are alive and free from disease progression will be censored at the date of last tumor assessment.
| Arm | Type | Description |
|---|---|---|
| Fruquinitinib + FOLFIRI | EXPERIMENTAL | Participants will receive an assigned dose level of fruquintinib in combination with FOLFIRI. Cycles will be 28 days, where participants will take fruquinitinib orally on Days 1 through 21 in combination with FOLFIRI intravenous infusion (IV) every 2 weeks. Up to 60 participants will be enrolled. |
| Name | Type | Description |
|---|---|---|
| fruquintinib | DRUG | Participants will receive oral fruquintinib, with or without food, for the first 21 days of each 28-day cycle. |
| FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) | DRUG | Participants will receive FOLFIRI once every 2 weeks on day 1 of every 28-day cycle (twice in each cycle). The FOLFIRI regimen consists of irinotecan given 180 mg/m2 intravenous infusion (IV), leucovorin 400 mg/m2 (or 200 mg/m2 levoleucovorin) IV, followed by 5-fluorouracil (5-FU) 400 mg/m2 bolus injection and 5-FU continuous IV infusion of 2400 mg/m2 over 46 to 48 hours. |
Key Inclusion Criteria: * Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1. * Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600 * Participants must have receive...
Fruquintinib is an investigational small molecule being studied for the treatment of colon cancer, specifically as a second-line treatment for participants with metastatic colorectal cancer (mCRC). It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Fruquintinib targets and inhibits FLT1, FLT4, and KDR, which are vascular endothelial growth factor receptors involved in tumor angiogenesis. By blocking these targets, fruquintinib is designed to interfere with the blood supply that tumors need to grow and spread.
Fruquintinib is being developed by Takeda Pharmaceutical Company Limited, a company listed on the stock exchange under the ticker symbol TAK. The drug is currently in Phase 2 clinical trials for the treatment of metastatic colorectal cancer.
Fruquintinib is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 2 trial is recruiting participants to evaluate its safety and efficacy.
Fruquintinib is being studied in a Phase 2 clinical trial with the identifier NCT07011576. This trial is titled 'A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)' and is currently recruiting participants in the United States.
Fruquintinib is a distinct small molecule drug and is not known by any alternative names. It is being investigated as a monotherapy or in combination with other agents, such as FOLFIRI, for the treatment of metastatic colorectal cancer.