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A Phase 1b Study Evaluating AMG 232 Alone and in Combination With Trametinib in Acute Myeloid Leukemia

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: NCT02016729
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Kartos Therapeutics, Inc.

Brief Summary:
Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute myeloid leukemia.

Condition or disease Intervention/treatment Phase
Advanced Malignancy Cancer Oncology Oncology Patients Acute Myeloid Leukemia Drug: AMG 232 Drug: Trametinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 232 Alone and in Combination With Trametinib in Adult Subjects With Relapsed/Refractory Acute Myeloid Leukemia
Actual Study Start Date : April 1, 2014
Actual Primary Completion Date : April 19, 2017
Actual Study Completion Date : July 31, 2017


Arm Intervention/treatment
Experimental: AMG 232
AMG 232 is an anti-cancer agent
Drug: AMG 232
Given an an oral tablet in escalating doses.

Drug: Trametinib
Trametinib is an oral tablet given in a fixed dose.

Experimental: AMG 232 & Trametinib
AMG 232 and Trametinib are anti cancer agents
Drug: Trametinib
Trametinib is an oral tablet given in a fixed dose.




Primary Outcome Measures :
  1. To evaluate the safety and tolerability of AMG 232 [ Time Frame: 36 months ]
    To evaluate the safety and tolerability of AMG 232 by reviewing clinically significant or ≥ Grade 3 changes in safety laboratory tests, physical examinations, ECGs, or vitals signs in all subjects enrolled.

  2. Characterize the pharmacokinetics of AMG 232 alone and in combination with trametinib when administered orally. [ Time Frame: 36 months ]
    PK parameters will include, but are not limited to, area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax).

  3. Determine the maximum tolerated dose of AMG 232 alone and in combination with trametinib, if possible. [ Time Frame: 36 months ]
    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.


Secondary Outcome Measures :
  1. Treatment Response [ Time Frame: 36 months ]
    Complete response (CR), complete response with incomplete recovery (CRi), and duration response.



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:

  • Men or women > 18 years old
  • Pathologically-documented, definitively-diagnosed AML that is relapsed or refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy
  • Ability to take oral medications and willing to record daily adherance to investigational product
  • Adequate hematological, renal, hepatic, and coagulation laboratory assessments

Exclusion Criteria:

  • Active infection requiring intravenous (IV) antibiotics
  • Prior participation in an investigational study (procedure or device) within 21 days of study day 1
  • Major surgery within 28 days of study day 1
  • Anti-tumor therapy within 14 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): NCT02016729


Locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States, 35294
United States, New York
Research Site
Buffalo, New York, United States, 14263
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28204
United States, Utah
Research Site
Salt Lake City, Utah, United States, 84112
United States, Washington
Research Site
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Kartos Therapeutics, Inc.
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: Kartos Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02016729    
Other Study ID Numbers: 20120234
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Keywords provided by Kartos Therapeutics, Inc.:
AML
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Trametinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action