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Safety Study of AMG 228 to Treat Solid Tumors

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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

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.

Condition or disease Intervention/treatment Phase
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 Drug: AMG 228 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 228 in Subjects With Selected Advanced Solid Tumors
Study Start Date : April 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: AMG 228
AMG 228 will be administered intravenously




Primary Outcome Measures :
  1. Subject incidence of dose limiting toxicities (DLT) [ Time Frame: 9 months ]
  2. Subject incidence of treatment-emergent adverse events [ Time Frame: 9 months ]
  3. Subject incidence of treatment-related adverse events [ Time Frame: 9 months ]
  4. Subject incidence of clinically significant changes in vital signs and physical assessments [ Time Frame: 9 months ]
  5. Subject incidence of clinically significant changes in ECGs [ Time Frame: 9 months ]
  6. Subject incidence of clinically significant changes in clinical laboratory tests [ Time Frame: 9 months ]
  7. AMG 228 maximum observed concentration (Cmax) [ Time Frame: 9 months ]
  8. AMG 228 minimum observed concentration (Cmin) [ Time Frame: 9 months ]
  9. AMG 228 area under the concentration-time curve (AUC) [ Time Frame: 9 months ]
  10. AMG 228 half-life (t1/2) [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: 9 months ]
  2. Incidence of anti-AMG 228 antibody formation [ Time Frame: 9 months ]
  3. Activation status and changes in numbers of T regulator cells (Treg) [ Time Frame: 9 months ]
  4. Subject objective response per immune-related Response Criteria (irRC) [ Time Frame: 9 months ]
  5. Activation status of cytotoxic T lymphocytes (CTL) [ Time Frame: 9 months ]
  6. Changes in numbers of cytotoxic T lymphocytes (CTL) [ Time Frame: 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437916


Locations
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United States, California
Research Site
La Jolla, California, United States, 92093
United States, Connecticut
Research Site
New Haven, Connecticut, United States, 06520
United States, New York
Research Site
New York, New York, United States, 10032
Australia, Victoria
Research Site
Parkville, Victoria, Australia, 3050
Belgium
Research Site
Leuven, Belgium, 3000
France
Research Site
Villejuif, France, 94805
Germany
Research Site
Heidelberg, Germany, 69120
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02437916     History of Changes
Other Study ID Numbers: 20140131
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017

Keywords provided by Amgen:
Melanoma
Non-small Cell Lung Cancer (NSCLC)
Squamous Cell Carcinoma
Carcinoma
Head and Neck
Transitional Cell Carinoma (TCC)
Bladder
Colorectal
Colorectal Cancer (CRC)

Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Colorectal Neoplasms
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases