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A Study of AMG 337 in Subjects With Advanced Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01253707
First received: November 24, 2010
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Advanced Malignancy
Advanced Solid Tumors
Cancer
Oncology
Oncology Patients
Tumors
Drug: AMG 337
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate for clinical responses associated with AMG 337 treatment according to Response Evaluation Criteria In Solid Tumors 1.1 criteria [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 149
Study Start Date: December 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253707

Contacts
Contact: Amgen Call Center 866-572-6436

Locations
United States, California
Research Site Recruiting
Los Angeles, California, United States, 90025
United States, Georgia
Research Site Recruiting
Atlanta, Georgia, United States, 30332
United States, Illinois
Research Site Recruiting
Chicago, Illinois, United States, 60637
United States, Massachusetts
Research Site Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Research Site Recruiting
Detroit, Michigan, United States, 48201
United States, Ohio
Research Site Recruiting
Columbus, Ohio, United States, 43210
United States, Tennessee
Research Site Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Research Site Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01253707     History of Changes
Other Study ID Numbers: 20101132
Study First Received: November 24, 2010
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration
United States: MD Anderson Surveillance Committee FWA-363
United States: Dana Farber Cancer Institute IRB
United State: Western Institutional Review Board
United States: Wayne State University Human Investigation Committee

Keywords provided by Amgen:
Solid Tumors
C-met inhibitor

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014