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Safety Study of AMG 228 to Treat 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: NCT02437916
Recruitment Status : Terminated (Business decision.)
First Posted : May 8, 2015
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE April 3, 2015
First Posted Date  ICMJE May 8, 2015
Last Update Posted Date February 6, 2017
Study Start Date  ICMJE April 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2015)
  • Subject incidence of dose limiting toxicities (DLT) [ Time Frame: 9 months ]
  • Subject incidence of treatment-emergent adverse events [ Time Frame: 9 months ]
  • Subject incidence of treatment-related adverse events [ Time Frame: 9 months ]
  • Subject incidence of clinically significant changes in vital signs and physical assessments [ Time Frame: 9 months ]
  • Subject incidence of clinically significant changes in ECGs [ Time Frame: 9 months ]
  • Subject incidence of clinically significant changes in clinical laboratory tests [ Time Frame: 9 months ]
  • AMG 228 maximum observed concentration (Cmax) [ Time Frame: 9 months ]
  • AMG 228 minimum observed concentration (Cmin) [ Time Frame: 9 months ]
  • AMG 228 area under the concentration-time curve (AUC) [ Time Frame: 9 months ]
  • AMG 228 half-life (t1/2) [ Time Frame: 9 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • Subject incidence of dose limiting toxicities (DLT) [ Time Frame: 9 months ]
  • Subject incidence of treatment-emergent adverse events [ Time Frame: 9 months ]
  • Subject incidence of treatment-related adverse events [ Time Frame: 9 months ]
  • Subject incidence of clinically significant changes in vital signs and physical assessments (composite) [ Time Frame: 9 months ]
  • Subject incidence of clinically significant changes in ECGs [ Time Frame: 9 months ]
  • Subject incidence of clinically significant changes in clinical laboratory tests (composite) [ Time Frame: 9 months ]
  • AMG 228 maximum observed concentration (Cmax) [ Time Frame: 9 months ]
  • AMG 228 minimum observed concentration (Cmin) [ Time Frame: 9 months ]
  • AMG 228 area under the concentration-time curve (AUC) [ Time Frame: 9 months ]
  • AMG 228 half-life (t1/2) [ Time Frame: 9 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: 9 months ]
  • Incidence of anti-AMG 228 antibody formation [ Time Frame: 9 months ]
  • Activation status and changes in numbers of T regulator cells (Treg) [ Time Frame: 9 months ]
  • Subject objective response per immune-related Response Criteria (irRC) [ Time Frame: 9 months ]
  • Activation status of cytotoxic T lymphocytes (CTL) [ Time Frame: 9 months ]
  • Changes in numbers of cytotoxic T lymphocytes (CTL) [ Time Frame: 9 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of AMG 228 to Treat Solid Tumors
Official Title  ICMJE A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 228 in Subjects With Selected Advanced Solid Tumors
Brief Summary The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity, and identify a tolerable dose of AMG 228 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
  • Melanoma
  • Non-small Cell Lung Cancer
  • Squamous Cell Carcinoma of the Head and Neck
  • Transitional Cell Carinoma of Bladder
  • Colorectal Cancer
Intervention  ICMJE Drug: AMG 228
AMG 228 will be administered intravenously
Study Arms  ICMJE Experimental: AMG 228 monotherapy
Part 1 and Part 2 of the study will both be with single agent AMG 228 in different selected tumor types.
Intervention: Drug: AMG 228
Publications * Tran B, Carvajal RD, Marabelle A, Patel SP, LoRusso PM, Rasmussen E, Juan G, Upreti VV, Beers C, Ngarmchamnanrith G, Schöffski P. Dose escalation results from a first-in-human, phase 1 study of glucocorticoid-induced TNF receptor-related protein agonist AMG 228 in patients with advanced solid tumors. J Immunother Cancer. 2018 Sep 25;6(1):93. doi: 10.1186/s40425-018-0407-x.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: November 9, 2016)
30
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2015)
100
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must have a pathologically documented, definitively diagnosed, advanced solid tumor
  • Adequate hematological, renal, hepatic, and coagulation laboratory assessments

Exclusion Criteria:

  • Active autoimmune disease, history of autoimmune disease
  • Treatment with immune modulators including
  • Use of warfarin, factor Xa inhibitors, or direct thrombin inhibitors
  • Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days
  • Major surgery within 28 days of study day 1
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 Australia,   Belgium,   France,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02437916
Other Study ID Numbers  ICMJE 20140131
Has Data Monitoring Committee No
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 February 2017

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