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

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ClinicalTrials.gov Identifier: NCT02110355
Recruitment Status : Active, not recruiting
First Posted : April 10, 2014
Last Update Posted : February 16, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Malignancy Advanced Solid Tumors Cancer Oncology Oncology Patients Tumors Melanoma Drug: AMG 232 Drug: Trametinib Drug: Dabrafenib Phase 1 Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
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
Actual Study Start Date : December 19, 2014
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : August 17, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110355


Locations
United States, California
Research Site
Los Angeles, California, United States, 90095
United States, Colorado
Research Site
Aurora, Colorado, United States, 80045
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02114
United States, North Carolina
Research Site
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37232
Australia, New South Wales
Research Site
North Sydney, New South Wales, Australia, 2060
Australia, Victoria
Research Site
East Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Amgen
GlaxoSmithKline
Investigators
Study Director: MD Amgen
More Information
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Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02110355     History of Changes
Other Study ID Numbers: 20120238
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

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