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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-19

Study Completion Date

2018-12-27

Brief Summary

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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.

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Detailed Description

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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.

Only Part 1 of the study was enrolled and the study did not proceed into Phase 2.

Conditions

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Advanced Malignancy Advanced Solid Tumors Cancer Oncology Oncology Patients Tumors Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AMG 232 with Trametinib and Dabrabenib

Arm 1 of Part 1 and 2 and Part 3

Group Type EXPERIMENTAL

AMG 232

Intervention Type DRUG

Given as an oral tablet in escalating doses

Trametinib

Intervention Type DRUG

Trametinib is an anti-cancer agent

Dabrafenib

Intervention Type DRUG

Dabrafenib is an anti-cancer agent

AMG 232 with Trametinib

Arm 2 of Part 1 and 2

Group Type EXPERIMENTAL

AMG 232

Intervention Type DRUG

Given as an oral tablet in escalating doses

Trametinib

Intervention Type DRUG

Trametinib is an anti-cancer agent

Trametinib and Dabrafenib

Part 3

Group Type ACTIVE_COMPARATOR

Trametinib

Intervention Type DRUG

Trametinib is an anti-cancer agent

Dabrafenib

Intervention Type DRUG

Dabrafenib is an anti-cancer agent

Interventions

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AMG 232

Given as an oral tablet in escalating doses

Intervention Type DRUG

Trametinib

Trametinib is an anti-cancer agent

Intervention Type DRUG

Dabrafenib

Dabrafenib is an anti-cancer agent

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No