Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...