NCT03698825

TEW-7197 with Paclitaxel for the Treatment of Metastatic Gastric Cancer

An Open-label, Multicenter Phase Ib/2a Study of TEW-7197 (Vactosertib) Plus Weekly Paclitaxel As Second-line Treatment for Metastatic Gastric Adenocarcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: MedPacto, Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single arm study evaluating the safety and tolerability of TEW-7197 in combination with paclitaxel in metastatic gastric cancer patients.

Detailed description

In the dose escalation step (phase 1b), 3 subjects are registered for each dose step, and the DLT is evaluated by administering the investigational product for 1 cycle (28 days). However, for reasons other than toxicity related to the test drug, the patient was given a combination of Paclitaxel and TEW-7197 (Vactosertib) during the DLT evaluation period during the first cycle of the planned TEW-7197. If more than 80% of the administered dose of (Vactosertib) is not administered, the patient will be considered unevaluable for DLT and another patient will be enrolled. At the end of one cycle of each cohort, the SMC decides whether to proceed to the next cohort. After completing the DLT evaluation of the final phase 1 cohort, the recommended dose to proceed in the dose expansion phase (Phase 2a) is determined. For subjects who have completed one cycle (DLT evaluation period), administer the investigational drug at the same dose until disease progression or unacceptable toxicity occurs. Tumor imaging (CT or MRI) for tumor evaluation is performed after screening and C1D1. Assessment every 6 weeks (±2 weeks) and at the end of treatment (EOT/DC). As efficacy evaluation items, PFS, OS, ORR, and DCR are evaluated according to RECIST 1.1, and the amount of change in the biomarker is confirmed. In the dose expansion phase (phase 2a), 50 patients will be enrolled at the dose determined in the dose escalation phase. Tumor imaging (CT or MRI) for tumor evaluation is evaluated every 6 weeks (±2 weeks) after screening and C1D1, and at the end of treatment (EOT/DC). As validity evaluation items, PFS, OS, ORR, and DCR according to RECIST 1.1 are evaluated, and the amount of change in the biomarker is confirmed.

Conditions

• Metastatic Gastric Cancer

Interventions

Type	Name	Description
DRUG	TEW-7197	TEW-7197 50mg tablets + Paclitaxel 80 mg/m2 D1, 8, 15 q 4 weeks TEW-7197 dose will be determined through this dose escalation study

Timeline

• Start date: 2018-08-15
• Primary completion: 2022-01-03
• Completion: 2022-12-28
• First posted: 2018-10-09
• Last updated: 2024-12-09

Locations

6 sites across 1 country: South Korea