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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.
 
ClinicalTrials.gov Identifier: NCT01253707
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE November 24, 2010
First Posted Date  ICMJE December 3, 2010
Last Update Posted Date December 23, 2016
Study Start Date  ICMJE December 2010
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2013)
  • 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 ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2010)
  • 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 ]
  • 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 ]
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
Evaluate for clinical responses associated with AMG 337 treatment according to Response Evaluation Criteria In Solid Tumors 1.1 criteria [ Time Frame: 4 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2010)
  • Evaluate for clinical responses associated with AMG 337 treatment according to Response Evaluation Criteria In Solid Tumors 1.1 criteria [ Time Frame: 3 years ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of AMG 337 in Subjects With Advanced Solid Tumors
Official Title  ICMJE A Phase 1, First-In-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AMG 337 in Adult Subjects With Advanced Solid Tumors
Brief Summary First in human, open-label, sequential dose escalation and expansion study of AMG 337 in subjects with advanced solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Malignancy
  • Advanced Solid Tumors
  • Cancer
  • Oncology
  • Oncology Patients
  • Tumors
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Dose Escalation
Intervention: Drug: AMG 337
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2015)
111
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2010)
83
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01253707
Other Study ID Numbers  ICMJE 20101132
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date December 2016

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