A Phase 1b/2a Study Evaluating AMG 232 in Metastatic Melanoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02110355 |
Recruitment Status :
Completed
First Posted : April 10, 2014
Last Update Posted : March 26, 2021
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Condition or disease | Intervention/treatment | Phase |
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Advanced Malignancy Advanced Solid Tumors Cancer Oncology Oncology Patients Tumors Melanoma | Drug: AMG 232 Drug: Trametinib Drug: Dabrafenib | Phase 1 |
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.
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 |
Actual Primary Completion Date : | December 27, 2018 |
Actual Study Completion Date : | December 27, 2018 |

Arm | Intervention/treatment |
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Experimental: AMG 232 with Trametinib and Dabrabenib
Arm 1 of Part 1 and 2 and Part 3
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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
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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
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Drug: Trametinib
Trametinib is an anti-cancer agent Drug: Dabrafenib Dabrafenib is an anti-cancer agent |
- 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
- 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

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

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
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 | |
Melbourne, Victoria, Australia, 3000 |
Study Director: | John Mei | Kartos Therapeutics |
Responsible Party: | Kartos Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT02110355 |
Other Study ID Numbers: |
20120238 |
First Posted: | April 10, 2014 Key Record Dates |
Last Update Posted: | March 26, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Metastatic melanoma |
Neoplasms Melanoma 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 |