Brief Summary
This is a multi-centre Phase 2 study. The study will evaluate the activity and safety of AMG 337 in patients who have MET amplified gastric, gastroesophageal junction or esophageal adenocarcinoma or other MET amplified solid tumors. The study is designed to estimate the objective response rate of AMG 337 by tumor type.
Brief Title
Phase 2 Study of AMG 337 in MET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors
Detailed Description
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.
Tumor tissue, biomarkers, Pharmacokinetics and Patient reported Outcomes will all be assessed.
Tumor assessment by RECIST 1.1 will be followed during study treatment.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Stomach Neoplasms
Eligibility Criteria
Inclusion Criteria:
* Able to daily self-administer AMG 337 orally as a whole capsule
* Male or female 18 years of age or over.
* Pathologically confirmed advanced G/GEJ/E adenocarcinoma (Cohort 1) or other solid tumor (Cohort 2) for which subject has received prior therapy for advanced disease, for which no standard therapy exists, or subject refuses standard therapy
* Tumor MET amplified by protocol-specified centralized testing.
* Measurable disease per RECIST 1.1 guidelines. Cohort 2 may include up to 10 subjects with advanced MET amplified, G/GEJ/E adenocarcinoma with non-measurable tumor per RECIST v1.1
* (ECOG) Performance Status of 0, 1 or 2
Exclusion Criteria:
* Known central nervous system metastases
* Candidate for curative surgery or definitive chemoradiation
* Peripheral edema \> grade 1
* Persistent gastric outlet obstruction, complete dysphagia or are dependent upon jejunostomy for feeding. Significant gastrointestinal disorder(s) that in the opinion of the Investigator may influence drug absorption
* Acute Hepatitis B. Chronic Hepatitis B eligible if condition is stable and, in the opinion of the investigator or Amgen physician, if consulted, would not pose a risk to subject safety
* Detectable Hepatitis C virus (indicative of active Hepatitis C)
* Currently receiving any anti-tumor treatments, or less than 14 days prior to enrollment since ending anti-tumor treatment
* Prior treatment with small molecule inhibitors of the MET pathway.
Other protocol defined inclusion criteria may apply.
* Able to daily self-administer AMG 337 orally as a whole capsule
* Male or female 18 years of age or over.
* Pathologically confirmed advanced G/GEJ/E adenocarcinoma (Cohort 1) or other solid tumor (Cohort 2) for which subject has received prior therapy for advanced disease, for which no standard therapy exists, or subject refuses standard therapy
* Tumor MET amplified by protocol-specified centralized testing.
* Measurable disease per RECIST 1.1 guidelines. Cohort 2 may include up to 10 subjects with advanced MET amplified, G/GEJ/E adenocarcinoma with non-measurable tumor per RECIST v1.1
* (ECOG) Performance Status of 0, 1 or 2
Exclusion Criteria:
* Known central nervous system metastases
* Candidate for curative surgery or definitive chemoradiation
* Peripheral edema \> grade 1
* Persistent gastric outlet obstruction, complete dysphagia or are dependent upon jejunostomy for feeding. Significant gastrointestinal disorder(s) that in the opinion of the Investigator may influence drug absorption
* Acute Hepatitis B. Chronic Hepatitis B eligible if condition is stable and, in the opinion of the investigator or Amgen physician, if consulted, would not pose a risk to subject safety
* Detectable Hepatitis C virus (indicative of active Hepatitis C)
* Currently receiving any anti-tumor treatments, or less than 14 days prior to enrollment since ending anti-tumor treatment
* Prior treatment with small molecule inhibitors of the MET pathway.
Other protocol defined inclusion criteria may apply.
Inclusion Criteria
Inclusion Criteria:
* Able to daily self-administer AMG 337 orally as a whole capsule
* Male or female 18 years of age or over.
* Pathologically confirmed advanced G/GEJ/E adenocarcinoma (Cohort 1) or other solid tumor (Cohort 2) for which subject has received prior therapy for advanced disease, for which no standard therapy exists, or subject refuses standard therapy
* Tumor MET amplified by protocol-specified centralized testing.
* Measurable disease per RECIST 1.1 guidelines. Cohort 2 may include up to 10 subjects with advanced MET amplified, G/GEJ/E adenocarcinoma with non-measurable tumor per RECIST v1.1
* (ECOG) Performance Status of 0, 1 or 2
* Able to daily self-administer AMG 337 orally as a whole capsule
* Male or female 18 years of age or over.
* Pathologically confirmed advanced G/GEJ/E adenocarcinoma (Cohort 1) or other solid tumor (Cohort 2) for which subject has received prior therapy for advanced disease, for which no standard therapy exists, or subject refuses standard therapy
* Tumor MET amplified by protocol-specified centralized testing.
* Measurable disease per RECIST 1.1 guidelines. Cohort 2 may include up to 10 subjects with advanced MET amplified, G/GEJ/E adenocarcinoma with non-measurable tumor per RECIST v1.1
* (ECOG) Performance Status of 0, 1 or 2
Gender
All
Gender Based
false
Keywords
MET Amplified Gastric / Gastroesophageal Junction / Esophageal Adenocarcinoma, or other solid tumors.
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02016534
Org Class
Industry
Org Full Name
Amgen
Org Study Id
20130111
Overall Status
Terminated
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Determine antitumor activity of AMG 337 in subjects with MET amplified G/GEJ/E adenocarcinoma
Outcome Measure
Objective Response Rate (RECIST v1.1) in subjects with MET Amplified measurable G/GEJ/E adenocarcinoma (Cohort 1)
Outcome Time Frame
2.5 years
Secondary Ids
Secondary Id
2013-001277-24
Secondary Outcomes
Outcome Time Frame
2.5 years
Outcome Measure
Duration of response (cohort 1 and subjects with measurable disease at baseline in cohort 2)
Outcome Time Frame
2.5 years
Outcome Measure
Time to response (Cohort 1 and subjects with measurable disease at baseline in cohort 2)
Outcome Time Frame
2.5 years
Outcome Measure
Progression free survival
Outcome Time Frame
2.5 years
Outcome Measure
Overall survival
Outcome Time Frame
2.5 years
Outcome Measure
Incidence and severity of adverse events and significant laboratory abnormalities
Outcome Time Frame
2.5 years
Outcome Measure
AMG 337 exposure and dose intensity
Outcome Description
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).
Outcome Time Frame
2.5 years
Outcome Measure
Pharmacokinetic parameters
Outcome Description
Determine antitumor activity of AMG 337 in subjects with other MET amplified solid tumors.
Outcome Time Frame
2.5 years
Outcome Measure
Objective Response Rate (per RECIST v1.1) in subjects with other MET amplified solid tumors (subjects with measurable disease in cohort 2).
See Also Links
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Bilal Piperdi
Investigator Email
bpiperdi@montefiore.org
Investigator Phone
BPIPERDI
Categories Mesh Debug
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL DISEASES
Digestive System --- GASTROINTESTINAL DISEASES
Gastrointestinal (GI) Cancers --- STOMACH DISEASES
MeSH Terms
STOMACH NEOPLASMS
ADENOCARCINOMA OF ESOPHAGUS
GASTROINTESTINAL NEOPLASMS
DIGESTIVE SYSTEM NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
DIGESTIVE SYSTEM DISEASES
GASTROINTESTINAL DISEASES
STOMACH DISEASES
AMG 337