A MULTICENTER, PHASE 2, SINGLE ARM, TWO COHORT STUDY EVALUATING THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF AMG 337 IN SUBJECTS WITH MET AMPLIFIED GASTRIC/GASTROESOPHAGEAL JUNCTION/ESOPHAGEAL ADENOCARCINOMA OR OTHER MET AMPLIFIED SOLID TUMORS

Not Applicable

• Conditions: -D001 Oesophagus-D002 Stomach; Oesophagus; Stomach; D001; D002

• Registration Number: PER-080-13
• Lead Sponsor: AMGEN INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-27
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Informed consent/assent provided prior to initiation of any study-specific activities/procedures. Subjects have agreed to and are able to daily self-administer AMG 337 orally as a whole capsule. Male or female subjects ≥ 18 years of age. Subjects must have a pathologically confirmed advanced G/GEJ/E adenocarcinoma (Cohort 1) or other solid tumor (Cohort 2) for which the subject has received prior therapy for advanced disease, or for which no standard therapy exists, or the subject refuses standard therapy. Tumor MET amplified by protocol-specified centralized testing. Availability of recent (preferred) or archival tumor tissue. 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. Eastern Cooperative
Oncology Group (ECOG) Performance Status of 0 or 1. Adequate organ function as evidenced
by the following laboratory studies within 28 days prior to enrollment: - Hemoglobin ≥ 9 g/dL. - Absolute neutrophil count ≥ 1.5 x 109/L. - Platelet count ≥ 100 x 109/L. - Creatinine clearance ≥ 50 mL/minute (calculated or measured). - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) or AST and ALT ≤ 5.0 x ULN if liver metastases are present. - Total bilirubin (TBL) ≤ 1.5 x ULN. - International normalized ratio (INR) ≤ ULN

Exclusion Criteria

Known central nervous system metastases. Subject is a candidate for curative surgery or definitive chemoradiation. Peripheral edema > grade 1. Currently receiving any anti-tumor treatments, or less than 14 days prior to enrollment since ending anti-tumor treatment. Therapeutic or palliative radiation therapy less than 14 days prior to study day 1 or still experiencing toxicities from radiation therapy or radiation therapy administered to the only site of disease. Use of a strong CYP3A4 inhibitor less than 14 days prior to study day 1. Ingestion of grapefruit or grapefruit products and other foods that are known to inhibit CYP3A4 less than 7 days prior to study day 1. Use of strong CYP3A4 inducers less than 14 days prior to study day
1. Use of St. John’s Wort and other herbal supplements known to induce CYP3A4 less than
14 days prior to study day 1.
For a full list of eligibility criteria, please refer to Section 4.1. through Section 4.2 of the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified