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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Amgen
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02110355
First received: April 8, 2014
Last updated: July 12, 2017
Last verified: June 2017
  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.

Condition Intervention Phase
Advanced Malignancy Advanced Solid Tumors Cancer Oncology Oncology Patients Tumors Melanoma Drug: AMG 232 Drug: Trametinib Drug: Dabrafenib Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ]
    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:
  • 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 ]
    Objective Tumor Response


Estimated Enrollment: 138
Actual Study Start Date: December 19, 2014
Estimated Study Completion Date: August 17, 2021
Estimated Primary Completion Date: April 15, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 232 with Trametinib and Dabrabenib
Arm 1 of Part 1 and 2 and Part 3
Drug: AMG 232
Given as an oral tablet in escalating doses
Drug: Trametinib
Trametinib is an anti-cancer agent
Drug: Dabrafenib
Dabrafenib is an anti-cancer agent
Experimental: AMG 232 with Trametinib
Arm 2 of Part 1 and 2
Drug: AMG 232
Given as an oral tablet in escalating doses
Drug: Trametinib
Trametinib is an anti-cancer agent
Active Comparator: Trametinib and Dabrafenib
Part 3
Drug: Trametinib
Trametinib is an anti-cancer agent
Drug: Dabrafenib
Dabrafenib is an anti-cancer agent

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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: NCT02110355

Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
United States, California
Research Site Completed
Los Angeles, California, United States, 90095
United States, Colorado
Research Site Recruiting
Aurora, Colorado, United States, 80045
United States, Massachusetts
Research Site Recruiting
Boston, Massachusetts, United States, 02114
United States, North Carolina
Research Site Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
Research Site Recruiting
Nashville, Tennessee, United States, 37232
Australia, New South Wales
Research Site Recruiting
North Sydney, New South Wales, Australia, 2060
Australia, Victoria
Research Site Recruiting
East Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Amgen
GlaxoSmithKline
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02110355     History of Changes
Other Study ID Numbers: 20120238
Study First Received: April 8, 2014
Last Updated: July 12, 2017

Keywords provided by Amgen:
Metastatic melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Trametinib
Dabrafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 19, 2017