NCT05171530

Lenvatinib With Taxane Drugs Treatment for Advanced Gastric Cancer

An Exploratory Clinical Study of Lenvatinib Combined With Single-agent Taxanes as Second-line Therapy for the Treatment of HER2-negative Advanced Gastric Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to study the safety and efficacy of lenvatinib combined with single-agent taxanes therapy in patients with HER2-negative advanced gastric cancer that have failed at the standard first-line therapy.

Detailed description

This study is being conducted to establish safety and preliminary efficacy of Lenvatinib plus taxane drugs treatment for HER2-negative advanced gastric cancer after failure of first-line treatment. The study will adopt the "3+3" dose escalation design. All patients received a standard dose of chemotherapy: paclitaxel 135mg/m2 every 3 weeks or docetaxel 75mg/m2 every 3 weeks. Lenvatinib is exploring four doses of 4mg, 8mg, 12mg, and 16mg, orally once a day every 3 weeks. In the first cycle, lenvatinib was administered 5 days before chemotherapy，once a day. Chemotherapy lasts up to 6 cycles, and lenvatinib continues to be administered until the disease progresses, intolerable side effects, or death. In order to avoid the possible ineffectiveness caused by the patient being exposed to low doses, the initial dose of 4 mg was enrolled in 1 patient. If there is no obvious dose-limiting toxicity (DLT) after the first dose, the dose escalation adopts a "3+3" method from the 8mg dose: if none of the 3 subjects in the previous dose group has a DLT within 21 days, the next dose study will be carried out; if one subject in the group has DLT occurs, then 3 additional subjects should be added to the dose group; if the 3 subjects have 1 or more DLTs, the trial terminated and the previous dose was regarded as the maximum tolerated dose (MTD).

Conditions

• HER2-negative Advanced Gastric Cancer

Interventions

Type	Name	Description
DRUG	Lenvatinib plus taxane drugs	* Drug: Paclitaxel Dose: 135mg/m2 Other Name: PTX * Drug: Docetaxel Dose: 75mg/m2 Other Name: FA * Drug: Lenvatinib Dose: 4mg, 8mg, 12mg,16mg Other Name: FA

Timeline

• Start date: 2022-01-05
• Primary completion: 2022-12-31
• Completion: 2023-06-30
• First posted: 2021-12-29
• Last updated: 2021-12-29

Locations

1 site across 1 country: China