Trials / Recruiting
RecruitingNCT05439993
Tepotinib Plus Paclitaxel in MET Amplified or MET Exon 14 Alterated Gastric and GEJ Carcinoma
A Phase 1b/2 Study of Tepotinib in Combination With Paclitaxel in Patients With MET Amplified or MET Exon 14 Alterated Advanced Gastric and Gastroesophageal Junction Carcinoma
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- Sponsor
- Hallym University Medical Center · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Purpose of this study is to define the maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of paclitaxel and tepotinib combination therapy in patients with advanced tumors and to evaluate the efficacy of paclitaxel and tepotinib combination treatment as second-line therapy in patients with advanced gastric and gastroesophageal junction carcinomas (AGC/GEJCs) with MET amplification or MET exon 14 alterations. This study is devided into Phase 1b and Phase 2 study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tepotinib plus paclitaxel | Paclitaxel 80mg/m2 on D1, 8, 15 tepotinib 250mg or 500mg daily on D1-28 Q 4weeks |
Timeline
- Start date
- 2022-03-01
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2022-06-30
- Last updated
- 2022-07-05
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05439993. Inclusion in this directory is not an endorsement.