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A Study of AMG 337 in Subjects With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01253707
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : December 23, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Advanced Malignancy Advanced Solid Tumors Cancer Oncology Oncology Patients Tumors Drug: AMG 337 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2010
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Dose Escalation Drug: 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 Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 Outcome Measures :
  1. Evaluate for clinical responses associated with AMG 337 treatment according to Response Evaluation Criteria In Solid Tumors 1.1 criteria [ Time Frame: 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01253707

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United States, California
Research Site
Los Angeles, California, United States, 90025
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30332
United States, Illinois
Research Site
Chicago, Illinois, United States, 60637
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02114
United States, Michigan
Research Site
Detroit, Michigan, United States, 48201
United States, Ohio
Research Site
Columbus, Ohio, United States, 43210
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37232
United States, Texas
Research Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen Identifier: NCT01253707    
Other Study ID Numbers: 20101132
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016
Keywords provided by Amgen:
Solid Tumors
C-met inhibitor
Additional relevant MeSH terms:
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