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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Kartos Therapeutics, Inc.
Study ID
NCT02016729
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AMG 232 — DRUG
    Given an an oral tablet in escalating doses.
  • Trametinib — DRUG
    Trametinib is an oral tablet given in a fixed dose.

Study Details

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

Key Dates

Start date
Apr 1, 2014
Status verified
Feb 2019
Primary completion
Apr 19, 2017
Completion
Jul 31, 2017

Study Design

Enrollment
36 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AMG 232
    AMG 232 is an anti-cancer agent
  • Experimental: AMG 232 & Trametinib
    AMG 232 and Trametinib are anti cancer agents

Primary Outcome Measure

To evaluate the safety and tolerability of AMG 232 [ Time Frame: 36 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35294-
Research SiteBuffaloNew York14263-
Research SiteCharlotteNorth Carolina28204-
Research SiteSalt Lake CityUtah84112-
Research SiteSeattleWashington98101-

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