A Study of AMG 337 in Subjects With Advanced Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01253707
First received: November 24, 2010
Last updated: December 26, 2013
Last verified: December 2013

November 24, 2010
December 26, 2013
December 2010
February 2015   (final data collection date for primary outcome 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 ] [ 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 ]
  • 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 ]
Complete list of historical versions of study NCT01253707 on ClinicalTrials.gov Archive Site
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 ]
  • 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 ]
Not Provided
Not Provided
 
A Study of AMG 337 in Subjects With Advanced Solid Tumors
A Phase 1, First-In-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AMG 337 in Adult Subjects With Advanced Solid Tumors

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

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Malignancy
  • Advanced Solid Tumors
  • Cancer
  • Oncology
  • Oncology Patients
  • Tumors
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.
Experimental: Dose Escalation
Intervention: Drug: AMG 337
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
149
June 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Amgen Call Center 866-572-6436
United States
 
NCT01253707
20101132
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP