A Study of AMG 337 in Subjects With Advanced Solid Tumors - Full Text View

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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: 3 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: 3 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: 3 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: 3 years ] [ Designated as safety issue: No ]
Evaluate for tumor anti-proliferative responses with AMG 337 treatment according to Fluoro-L-Thymidine Positron Emission Tomography (FLT-PET) scanning [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	83
Study Start Date:	December 2010
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	February 2014 (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

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 > 480 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
Concurrent or prior anticoagulation therapy within 7 days of study day 1
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

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, Massachusetts
Research Site	Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Research Site	Recruiting
Detroit, Michigan, United States, 48201
United States, Texas
Research Site	Recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

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:	July 13, 2012
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 May 22, 2013