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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
A Phase 1b/2a Study Evaluating AMG 232 in Metastatic Melanoma
Scientific 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
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Malignancy 0 0
Advanced Solid Tumors 0 0
Cancer 0 0
Oncology 0 0
Oncology Patients 0 0
Tumors 0 0
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Study type
Description of intervention(s) / exposure
Treatment: Drugs - AMG 232
Treatment: Drugs - Trametinib
Treatment: Drugs - Dabrafenib

Experimental: AMG 232 with Trametinib and Dabrabenib - Arm 1 of Part 1 and 2 and Part 3

Experimental: AMG 232 with Trametinib - Arm 2 of Part 1 and 2

Active Comparator: Trametinib and Dabrafenib - Part 3

Treatment: Drugs: AMG 232
Given as an oral tablet in escalating doses

Treatment: Drugs: Trametinib
Trametinib is an anti-cancer agent

Treatment: Drugs: Dabrafenib
Dabrafenib is an anti-cancer agent

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Subject incidence of treatment-emergent adverse events, Results of safety laboratory tests, vital sign measurements, ECG measurements, PK parameters; Progression-free Survival Rate - Incidence and grade of treatment-emergent adverse events, including dose-limiting toxicities; AMG 232, trametinib, dabrafenib, and metabolite PK parameters; progression-free Survival
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
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 - Objective Tumor Response
Timepoint [1] 0 0
36 months

Key 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
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
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

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - North Sydney
Recruitment hospital [2] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Country [2] 0 0
United States of America
State/province [2] 0 0
Country [3] 0 0
United States of America
State/province [3] 0 0
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications