Trials / Completed
CompletedNCT02096666
A Phase 1/2 Study Evaluating AMG 337 in Asian Subjects
A Multicenter, Phase 1/2, Open-Label Study Evaluating the Tolerability, Safety, Pharmacokinetics, and Efficacy of AMG 337 in Asian Subjects
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, Phase 1/2 study. The study will evaluate the tolerability, safety and activity of AMG 337 in Asian subjects who have advanced solid tumors (Phase 1) or subjects with MET amplified tumors with a focus on gastric/gastroesophageal junction/esophageal adenocarcinoma (Phase 2).
Detailed description
This is a Phase 1/2, multicenter, single arm, open-label study to assess the safety, efficacy and pharmacokinetics of AMG 337 in solid tumors. In the Phase 1, approximately 3 to 45 subjects enrolled in a 3+3+3 dose escalation scheme evaluating two dose levels. In the Phase 2, approximately 140 subjects will be enrolled to either Cohort 1 (subjects with MET amplified /gastroesophageal junction/esophageal (G/GEJ/E) adenocarcinoma with measurable tumor) or Cohort 2 (subjects with MET amplified solid tumors with measurable tumor and subjects with MET amplified G/GEJ/E adenocarcinoma with non-measurable tumor). All subjects will self-administer AMG 337 daily until disease progression or other protocol specified end of treatment criteria are met. Tumor assessment by RECIST 1.1 will be followed during study treatment. Tumor tissue, biomarkers, pharmacokinetics and Patient Reported Outcomes will be assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 337 | Phase 1- AMG 337 150 mg, 200mg and 300 mg orally daily. Additional 150 mg and 200 mg orally twice daily. Phase 2- AMG 337 (dose determined by Phase 1) |
Timeline
- Start date
- 2014-04-15
- Primary completion
- 2015-11-05
- Completion
- 2018-12-07
- First posted
- 2014-03-26
- Last updated
- 2021-12-28
Locations
4 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02096666. Inclusion in this directory is not an endorsement.