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AMG 176 First in Human Trial in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT02675452
Recruitment Status : Recruiting
First Posted : February 5, 2016
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
At least one dose level of AMG 176 will achieve acceptable safety and tolerability in subjects with relapsed or refractory multiple myeloma and subjects with relapsed or refractory acute myeloid leukemia

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Multiple Myeloma Relapsed or Refractory Acute Myeloid Leukemia Drug: AMG 176 Phase 1

Detailed Description:
This is a Phase 1, first-in-human, multicenter; non-randomized, open-label and dose-exploration study of AMG 176 administered IV in subjects with relapsed or refractory multiple myeloma and subjects with relapsed or refractory acute myeloid leukemia The study will be conducted in four parts.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 109 participants
Allocation: Non-Randomized
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 176 in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Actual Study Start Date : June 13, 2016
Estimated Primary Completion Date : September 3, 2020
Estimated Study Completion Date : October 5, 2021


Arm Intervention/treatment
Experimental: AMG 176 - Part 1a
Part 1a - dose exploration of the intervention, AMG 176
Drug: AMG 176
Study Drug
Other Name: Study Investigational Product (IP)

AMG 176 - Part 1b
Part 1b dose exploration. The intervention is AMG 176
Drug: AMG 176
Study Drug
Other Name: Study Investigational Product (IP)

AMG 176 - Part 2
Part 2 Combination therapy The intervention is AMG 176
Drug: AMG 176
Study Drug
Other Name: Study Investigational Product (IP)

Experimental: AMG 176 - Part 3
Part 3 - Dose exploration. The intervention is AMG 176
Drug: AMG 176
Study Drug
Other Name: Study Investigational Product (IP)




Primary Outcome Measures :
  1. Incidence of adverse events and significant laboratory abnormalities [ Time Frame: 6 months ]
  2. Evaluate PK on different cohorts [ Time Frame: 6 months ]
  3. Determine the maximum tolerated dose (MTD) [ Time Frame: 6 months ]
  4. Determine the maximum tolerated combination (MTC) [ Time Frame: 6 months on treatment ]

Secondary Outcome Measures :
  1. Demonstrate investigational product inactivation of MCL-1 [ Time Frame: 6 months on treatment ]
  2. Evaluate preliminary efficacy according to the International Myeloma Working Group uniform response criteria [ Time Frame: 6 months on treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA: -Pathologically documented, multiple myeloma relapsed or refractory disease after at least 2 lines of therapy, -Must be willing and able to undergo bone marrow biopsy at screening, -Measurable disease per the IMWG response criteria, -Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2, -Satisfactory hematological function without transfusion or growth factor support, -Subjects should not have received platelet transfusions for at least 1 week prior to screening, -Hemoglobin > 8 g/dL, -Subjects may receive RBC transfusions or receive supportive care), -Other Inclusion Criteria May Apply.

EXCLUSION CRITERIA: -Previously received an allogeneic stem cell transplant within 6 months OR having received immunosuppressive therapy within the last three months OR having signs or symptoms of acute or chronic graft-versus-host disease, -Autologous stem cell transplant less than 90 days prior to study day 1, -Multiple myeloma with IgM subtype, -POEMS syndrome, -Existing plasma cell leukemia, -Waldenstrom's macroglobulinemia, -Amyloidosis, -Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 7 days prior to starting treatment, -Topical or inhaled corticosteroids are permitted, -Infection requiring intravenous anti-infective treatments within 1 week of study enrollment (day 1), -Other exclusion Criteria May Apply.


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): NCT02675452


Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
United States, California
Research Site Recruiting
Duarte, California, United States, 91010
Research Site Recruiting
Sacramento, California, United States, 95817
United States, Illinois
Research Site Recruiting
Chicago, Illinois, United States, 60637-6613
United States, Louisiana
Research Site Recruiting
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Research Site Recruiting
Boston, Massachusetts, United States, 02114
United States, New Jersey
Research Site Recruiting
Hackensack, New Jersey, United States, 07601
United States, Texas
Research Site Recruiting
Houston, Texas, United States, 77030
United States, Utah
Research Site Recruiting
Salt Lake City, Utah, United States, 84112
Australia, Victoria
Research Site Recruiting
Melbourne, Victoria, Australia, 3004
Research Site Recruiting
Parkville, Victoria, Australia, 3050
Canada, Alberta
Research Site Recruiting
Calgary, Alberta, Canada, T2N 2T9
Canada, Ontario
Research Site Recruiting
Toronto, Ontario, Canada, M5G 2M9
Germany
Research Site Recruiting
Aachen, Germany, 52074
Research Site Recruiting
Ulm, Germany, 89081
Research Site Recruiting
Würzburg, Germany, 97080
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02675452     History of Changes
Other Study ID Numbers: 20150161
2015-004777-32 ( EudraCT Number )
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases