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Also known as fruquintinib
fruquintinib+paclitaxel · 2 trials · 2 indications
every two months follow up after EOT observation period at 30 days after the last medication
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause.
using RECIST v1.1 progressive disease (PD), using RECIST v 1.1
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 4.0.
| Arm | Type | Description |
|---|---|---|
| fruquintinib+paclitaxel | ACTIVE_COMPARATOR | treatment arm (fruquintinib+paclitaxel) : Fruquintinib once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/㎡ day1, 8, 15 of 4 weeks cycle. |
| placebo+paclitaxel | PLACEBO_COMPARATOR | control arm (placebo+paclitaxel): Fruquintinib placebo once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/㎡ day1, 8, 15 of 4 weeks cycle. |
| Name | Type | Description |
|---|---|---|
| fruquintinib +paclitaxel | COMBINATION_PRODUCT | treatment arm(fruquintinib +paclitaxel)- subjects will receive Fruquintinib orally, once daily for 3 wks on/ 1 wk off combined with paclitaxel 80mg/㎡ at day 1,8,15 of 4-week cycle. Patients will receive a cycles of 4 weeks of study treatment or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. |
| fruquintinib placebo + paclitaxel | COMBINATION_PRODUCT | control arm(fruquintinib placebo + paclitaxel)- subjects will receive Fruquintinib placebo orally, once daily for 3 wks on/ 1 wk off combined with paclitaxel 80mg/㎡ at day 1,8,15 of 4-week cycle. Patients will receive a cycles of 4 weeks of study treatment or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. |
| fruquintinib+paclitaxel | DRUG | 28-day cycle of fruquintinib qd for 3 weeks followed by 1-week break combined with paclitaxel 80 mg/m2 |
Inclusion Criteria: * Signed informed consent * Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma * Metastatic disease or locally advanced, unresectable disease * Disease progression during or within 4 months after the last dose of the first-line therapy ...
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Fruquintinib is an investigational small molecule kinase inhibitor being developed for oncology indications including colorectal cancer, gastric cancer, advanced renal cell carcinoma, and metastatic colorectal cancer. It is also being studied for drug-drug interactions and food effects in healthy subjects. The drug is not FDA approved and remains in clinical development.
Fruquintinib is a small molecule kinase inhibitor, belonging to the -tinib class of targeted therapies. It works by inhibiting kinase enzymes involved in tumor growth and angiogenesis. The drug is being studied across multiple cancer types, including colorectal and gastric cancers, where kinase signaling pathways are frequently dysregulated.
Fruquintinib is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed under the ticker HCM. The company is conducting clinical trials of the drug primarily in China across multiple oncology indications, including colorectal cancer and gastric cancer.
Fruquintinib is in Phase 1 clinical development, though completed trials have included Phase 2 and Phase 3 studies. The drug has received FDA designations of Priority Review and Breakthrough Therapy. It remains investigational and is not yet FDA approved for any indication.
Fruquintinib has been studied in several clinical trials, including NCT01975077 (Phase Ib in 3rd line metastatic colorectal cancer), NCT02196688 (Phase 2 in metastatic colorectal cancer), NCT02314819 (Phase 3 FRESCO trial in 3+ line colorectal cancer), and NCT03223376 (Phase 3 FRUTIGA trial in second line gastric cancer). These trials have been completed.
Fruquintinib is known by its generic name and does not have alternative names listed in the available data. It is a distinct small molecule kinase inhibitor being developed by HUTCHMED for multiple oncology indications, including colorectal cancer and gastric cancer.