Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02110355




Registration number
NCT02110355
Ethics application status
Date submitted
8/04/2014
Date registered
10/04/2014
Date last updated
26/03/2021

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
20120238
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

Intervention/exposure
Study type
Interventional
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

Outcomes
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
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
Timepoint [1] 0 0
36 months

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/12/2018
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
NSW,VIC
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
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
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
Tennessee

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Kartos Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
GlaxoSmithKline
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT02110355
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Mei
Address 0 0
Kartos Therapeutics
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02110355