A Study of AMG 337 in Subjects With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-08

Study Completion Date

2016-12-13

Brief Summary

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

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Detailed Description

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Conditions

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Advanced Malignancy Advanced Solid Tumors Cancer Oncology Oncology Patients Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

Group Type EXPERIMENTAL

AMG 337

Intervention Type DRUG

AMG 337 is a small molecule inhibitor of c-Met which is a receptor tyrosine kinase expressed on the surface of epithelial cells.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No