Clinical Trials /

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

NCT02110355

Description:

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.

Related Conditions:
  • Melanoma
Recruiting Status:

Completed

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1b/2a Study Evaluating AMG 232 in Metastatic Melanoma
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 20120238
  • NCT ID: NCT02110355

Conditions

  • Advanced Malignancy
  • Advanced Solid Tumors
  • Cancer
  • Oncology
  • Oncology Patients
  • Tumors
  • Melanoma

Interventions

DrugSynonymsArms
AMG 232AMG 232 with Trametinib and Dabrabenib
TrametinibAMG 232 with Trametinib and Dabrabenib
DabrafenibAMG 232 with Trametinib and Dabrabenib

Purpose

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.

Detailed Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
AMG 232 with Trametinib and DabrabenibExperimentalArm 1 of Part 1 and 2 and Part 3
  • AMG 232
  • Trametinib
  • Dabrafenib
AMG 232 with TrametinibExperimentalArm 2 of Part 1 and 2
  • AMG 232
  • Trametinib
Trametinib and DabrafenibActive ComparatorPart 3
  • Trametinib
  • Dabrafenib

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Subject incidence of treatment-emergent adverse events, Results of safety laboratory tests, vital sign measurements, ECG measurements, PK parameters; Progression-free Survival Rate
Time Frame:36 months
Safety Issue:
Description:Incidence and grade of treatment-emergent adverse events, including dose-limiting toxicities; AMG 232, trametinib, dabrafenib, and metabolite PK parameters; progression-free Survival

Secondary Outcome Measures

Measure:Time to and duration of overall response and duration of stable disease measured by CT or MRI and assessed per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, Progression-free and Overall Survival
Time Frame:36 months
Safety Issue:
Description:Objective Tumor Response

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Amgen

Trial Keywords

  • Metastatic melanoma

Last Updated

July 12, 2017