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Label indication 1. INDICATIONS AND USAGE FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy. FDA label
Also known as Fruzaqla, TAK-113, HMPL-013
fruquintinib · 2 trials · 5 indications
The primary endpoint is the Overall survival (OS) and is defined as the time between the date of randomization and the date of death caused by any reason or the date of last news if the patient is alive.
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 |
|---|---|---|
| Arm A (control arm): trifluridine/tipiracil | ACTIVE_COMPARATOR | Cycle of 28 days 35 mg/m2 by mouth twice daily on Days 1 to 5, 2 days of rest and 35 mg/m2 by mouth twice daily on days 8 to 12 |
| Arm B (experimental arm): trifluridine/tipiracil + fruquintinib | EXPERIMENTAL | Cycle of 28 days For trifluridine/tipiracil: 35 mg/m2 by mouth twice daily on Day 1 to 5, 2 days of rest and 35 mg/m2 by mouth twice daily on days 8 to 12 For fruquintinib: 5 mg by mouth once daily Day 1 to Day 21 (3 weeks) Treatment will be repeated every 4 weeks until radiological disease progression, unacceptable toxicity or patient's refusal. |
| 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 |
|---|---|---|
| trifluridine/tipiracil | DRUG | Cycle of 28 days 35 mg/m2 by mouth twice daily on Days 1 to 5, 2 days of rest and 35 mg/m2 by mouth twice daily on days 8 to 12 Treatment will be repeated every 4 weeks until radiological disease progression, unacceptable toxicity or patient's refusal. |
| fruquintinib | DRUG | For fruquintinib: 5 mg by mouth once daily Day 1 to Day 21 (3 weeks) Treatment will be repeated every 4 weeks until radiological disease progression, unacceptable toxicity or patient's refusal. |
| 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. |
Inclusion Criteria: 1. Age ≥ 18 years (patients enrolled gender independently). 2. Histologically proven metastatic adenocarcinoma of the stomach or the esophagogastric junction (GEJ) or esophagus. 3. Prior treatment by two or three lines of treatment for metastatic setting (patients who received a...
Fruquintinib is an investigational small molecule being studied in oncology for metastatic colorectal cancer and metastatic oesogastric adenocarcinoma. It is being evaluated as part of combination regimens, including with FOLFIRI in second-line metastatic colorectal cancer and with trifluridine/tipiracil in metastatic oesogastric adenocarcinoma.
Fruquintinib targets FLT1, FLT4, and KDR, which are receptor tyrosine kinases involved in angiogenesis. It acts as an inhibitor of these targets. By inhibiting FLT1, FLT4, and KDR, fruquintinib is designed to interfere with vascular signaling that supports tumor growth.
Fruquintinib is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the developer associated with the clinical trial program for fruquintinib in metastatic colorectal cancer and metastatic oesogastric adenocarcinoma.
Fruquintinib is in clinical development and is investigational. Its trials span Phase 2 and Phase 3. The Phase 2 study is evaluating fruquintinib plus FOLFIRI in second-line metastatic colorectal cancer, while the Phase 3 study is evaluating trifluridine/tipiracil plus fruquintinib versus trifluridine/tipiracil alone in metastatic oesogastric adenocarcinoma.
Fruquintinib is being studied in NCT07011576, a Phase 2 trial of fruquintinib plus FOLFIRI as second-line treatment for metastatic colorectal cancer in the United States, and NCT07270991, a Phase 3 trial comparing trifluridine/tipiracil plus fruquintinib versus trifluridine/tipiracil alone in metastatic oesogastric adenocarcinoma in France and Germany.