A Phase 1b/2a Study Evaluating AMG 232 in Metastatic Melanoma



Status:Completed
Conditions:Skin Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/19/2018
Start Date:December 19, 2014
End Date:December 11, 2018

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A Phase 1b/2a Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 232 Combined With Trametinib and Dabrafenib or Trametinib in Adult Subjects With Metastatic Cutaneous Melanoma

Phase 1b/2a, open-label, sequential dose escalation and expansion study of AMG 232 in
combination with trametinib and dabrafenib in subjects with metastatic melanoma followed by a
direct comparison of AMG 232 combined with trametinib and dabrafenib versus trametinib
combined with dabrafenib alone.

The study will be conducted in 3 parts: Part 1 - Dose Escalation, Part 2 - Dose Expansion and
Part 3, a randomized Phase 2a.

In both part 1 and 2, subjects will be enrolled open-label into 1 of 2 arms. For both Arm 1
and Arm 2, the part 1 dose escalation is aimed at determining an AMG 232 maximum tolerated
dose (MTD) with a fixed dose of the combination drug(s) and evaluating safety, tolerability,
pharmacokinetics and pharmacodynamics of each combination. Part 2 dose expansion will enroll
subjects to receive therapy with a dose and schedule of AMG 232 selected from the
corresponding part 1 dose escalation. In part 2 subjects will be enrolled to confirm safety
and tolerability and to assess clinical activity prior to proceeding to Part 3, Phase 2a. In
Phase 2a, Subjects will be randomized open-label in a 1:1 ratio to receive AMG 232 in
combination with trametinib plus dabrafenib versus trametinib plus dabrafenib alone.

Inclusion Criteria: Subjects must have histologically or cytologically confirmed metastatic
cutaneous or mucosal melanoma, Able to swallow and retain orally administered medication,
Adequate hematological, renal, hepatic, and coagulation laboratory assessments Exclusion
Criteria: Clinically significant bleeding within 4 weeks of screening, Current use of
warfarin, factor Xa inhibitors, and direct thrombin inhibitors, Infection requiring
anti-infective treatments within 1 week of study enrollment, Anti-tumor therapy, Major
surgery within 28 days
We found this trial at
6
sites
1026
mi
from 98109
Aurora, CO
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2485
mi
from 98109
Boston, MA
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2337
mi
from 98109
Chapel Hill, NC
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962
mi
from 98109
Los Angeles, CA
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1970
mi
from 98109
Nashville, TN
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North Sydney, New South Wales 2060
7747
mi
from 98109
North Sydney,
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