Overview

This trial is active, not recruiting.

Conditions advanced malignancy, advanced solid tumors, cancer, oncology, oncology patients, tumors
Treatment amg 337
Phase phase 1
Target c-MET
Sponsor Amgen
Start date December 2010
End date October 2015
Trial size 111 participants
Trial identifier NCT01253707, 20101132

Summary

First in human, open-label, sequential dose escalation and expansion study of AMG 337 in subjects with advanced solid tumors.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
amg 337
AMG 337 is a small molecule inhibitor of c-Met which is a receptor tyrosine kinase expressed on the surface of epithelial cells.

Primary Outcomes

Measure
To evaluate the safety and tolerability of AMG 337 by reviewing clinically significant or ≥ Grade 3 changes in safety laboratory tests, physical examinations, ECGs, or vitals signs in all subjects enrolled.
time frame: 4 years
Characterize the pharmacokinetics of AMG 337 when administered orally. PK parameters will include, but are not limited to, area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax).
time frame: 4 years
Determine the maximum tolerated dose of AMG 337, if possible. The MTD is defined at the highest dose level with an observed incidence of dose limiting toxicity in < 33% of subjects enrolled in a cohort.
time frame: 4 years

Secondary Outcomes

Measure
Evaluate for clinical responses associated with AMG 337 treatment according to Response Evaluation Criteria In Solid Tumors 1.1 criteria
time frame: 4 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Men or women ≥ 18 years old - Subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor - Subjects with primary central nervous system (CNS) tumors or metastases resected or have received radiation therapy ending at least 4 weeks prior to study day 1 are eligible providing they meet all of the following criteria: a) residual neurological symptoms grade ≤ 1; 2) no dexamethasone treatment; and c) follow-up MRI shows no new lesions appearing - Measurable disease per RECIST guidelines (subjects with non-measurable, but evaluable disease are also eligible for the dose escalation portion of the study) - Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 - Competent to sign and date an Institutional Review Board approved informed consent form - Adequate hematologic and renal function as determined by laboratory blood and urine tests Exclusion Criteria: - Men and woman of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and continuing for 2 weeks (for women) and 12 weeks (for men) after receiving the last dose of study drug. - Women who are lactating/breastfeeding or planning to become pregnant during the duration of the study - History of bleeding diathesis - Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication, or uncontrolled hypertension - A baseline ECG QTc > 470 ms - Active infection requiring (IV) antibiotics within 2 weeks of study enrollment - Significant gastrointestinal disorder(s), in the opinion of the investigator, that may influence drug absorption - Known positive test for HIV - Known acute or chronic hepatitis B or hepatitis C infection as determined by serologic tests - Anti-tumor therapy within 28 days of study day 1 including chemotherapy, antibody therapy, retinoid therapy, or other investigational agent - Major surgery within 30 days of study day 1 - Any co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsor

Additional Information

Official title A Phase 1, First-In-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AMG 337 in Adult Subjects With Advanced Solid Tumors
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Amgen.