Trial record 1 of 1 for:    NCT02016729
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A Phase 1b Study Evaluating AMG 232 Alone and in Combination With Trametinib in Acute Myeloid Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02016729
First received: November 21, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of AMG 232 [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    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.

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

  • Determine the maximum tolerated dose of AMG 232 alone and in combination with trametinib, if possible. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    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:
  • Treatment Response [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Complete response (CR), complete response with incomplete recovery (CRi), and duration response.


Estimated Enrollment: 130
Study Start Date: April 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02016729

Contacts
Contact: Amgen Call Center 866-572-6436

Locations
United States, Alabama
Research Site Recruiting
Birmingham, Alabama, United States, 35294
United States, New York
Research Site Recruiting
Buffalo, New York, United States, 14263
United States, Utah
Research Site Recruiting
Salt Lake City, Utah, United States, 84112
United States, Washington
Research Site Recruiting
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02016729     History of Changes
Other Study ID Numbers: 20120234
Study First Received: November 21, 2013
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Amgen:
AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Trametinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014