Phase 2 Study of AMG 337 in MET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Phase 2, Single Arm, Two Cohort Study Evaluating the Efficacy, Safety, and Pharmacokinetics of AMG337 in Subjects With MET Amplified Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma or Other MET Amplified Solid Tumors|
- Objective Response Rate (RECIST v1.1) in subjects with MET Amplified measurable G/GEJ/E adenocarcinoma (Cohort 1) [ Time Frame: 2.5 years ]Determine antitumor activity of AMG 337 in subjects with MET amplified G/GEJ/E adenocarcinoma
- Duration of response (cohort 1 and subjects with measurable disease at baseline in cohort 2) [ Time Frame: 2.5 years ]
- Time to response (Cohort 1 and subjects with measurable disease at baseline in cohort 2) [ Time Frame: 2.5 years ]
- Progression free survival [ Time Frame: 2.5 years ]
- Overall survival [ Time Frame: 2.5 years ]
- Incidence and severity of adverse events and significant laboratory abnormalities [ Time Frame: 2.5 years ]
- AMG 337 exposure and dose intensity [ Time Frame: 2.5 years ]
- Pharmacokinetic parameters [ Time Frame: 2.5 years ]Including, but not limited to, minimum (trough) concentrations at pre-dose times, maximum concentrations (C max), the time of C max (t max), and area under the plasma concentration - time curve (AUC).
- Objective Response Rate (per RECIST v1.1) in subjects with other MET amplified solid tumors (subjects with measurable disease in cohort 2). [ Time Frame: 2.5 years ]Determine antitumor activity of AMG 337 in subjects with other MET amplified solid tumors.
- Patient Reported Outcomes (PRO) Health related quality of life (HRQoL) [ Time Frame: 3 years ]To evaluate the impact of AMG 337 on health-related quality of life (HRQoL) in subjects with MET amplified G/GEJ/E adenocarcinoma (Cohort 1 only).
- Tumor tissue and circulating serum biomarkers [ Time Frame: 3 years ]assessed at baseline. Circulating tumor cells (CTC) and circulating serum biomarkers will also be assessed at baseline and during study treatment
- Prediction of response rates to AMG 337 by analysing tumor DNA for MET pathway-related genes [ Time Frame: 3 years ]To analyse tumor DNA samples for MET pathway-related genes (and other genes based on emerging data) that may predict response to AMG 337
- Response to AMG 337 and MET amplification, expression or presence of mutation in tumor specimens [ Time Frame: 3 years ]Explore whether the level of MET amplification, expression, or presence of mutation in tumor specimens correlates with response to AMG 337.
|Study Start Date:||February 2014|
|Study Completion Date:||October 2016|
|Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: Single arm
AMG 337 Monotherapy
Drug: AMG 337
AMG 337 300mg orally daily.
This is a phase 2, multicenter, single arm, 2 cohort study to assess the safety, efficacy and pharmacokinetics of AMG 337 in MET amplified Gastric/esophageal adenocarcinoma or other solid tumors. Approximately 140 subjects will be enrolled to either Cohort 1 (subjects with MET amplified G/E adenocarcinoma with measurable tumor) or Cohort 2 (subjects with MET amplified solid tumors with measurable tumor/up to 10 subjects with MET amplified G/E adenocarcinoma with non-measurable tumor/up to 10 subjects who have received prior MET antibody therapy). All subjects will self-administer AMG 337 300 mg daily until disease progression or other protocol specified end of treatment criteria is met.
Tumor tissue, biomarkers, Pharmacokinetics and Patient reported Outcomes will all be assessed.
Tumor assessment by RECIST 1.1 will be followed during study treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02016534
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