NCT02110355

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2014

Longer than P75 for phase_1

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

December 19, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2018

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

4 years

First QC Date

April 8, 2014

Last Update Submit

March 24, 2021

Conditions

Advanced MalignancyAdvanced Solid TumorsCancerOncologyOncology PatientsTumorsMelanoma

Keywords

Metastatic melanoma

Outcome Measures

Primary Outcomes (1)

  • 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

    36 months

Secondary Outcomes (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

    36 months

Study Arms (3)

AMG 232 with Trametinib and Dabrabenib

EXPERIMENTAL

Arm 1 of Part 1 and 2 and Part 3

Drug: AMG 232Drug: TrametinibDrug: Dabrafenib

AMG 232 with Trametinib

EXPERIMENTAL

Arm 2 of Part 1 and 2

Drug: AMG 232Drug: Trametinib

Trametinib and Dabrafenib

ACTIVE COMPARATOR

Part 3

Drug: TrametinibDrug: Dabrafenib

Interventions

AMG 232DRUG

Given as an oral tablet in escalating doses

AMG 232 with TrametinibAMG 232 with Trametinib and Dabrabenib
TrametinibDRUG

Trametinib is an anti-cancer agent

AMG 232 with TrametinibAMG 232 with Trametinib and DabrabenibTrametinib and Dabrafenib
DabrafenibDRUG

Dabrafenib is an anti-cancer agent

AMG 232 with Trametinib and DabrabenibTrametinib and Dabrafenib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site

Los Angeles, California, 90095, United States

Location

Research Site

Aurora, Colorado, 80045, United States

Location

Research Site

Boston, Massachusetts, 02114, United States

Location

Research Site

Chapel Hill, North Carolina, 27599, United States

Location

Research Site

Nashville, Tennessee, 37232, United States

Location

Research Site

North Sydney, New South Wales, 2060, Australia

Location

Research Site

Melbourne, Victoria, 3000, Australia

Location

MeSH Terms

Conditions

NeoplasmsMelanoma

Interventions

2-(5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-(1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acidtrametinibdabrafenib

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • John Mei

    Kartos Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 10, 2014

Study Start

December 19, 2014

Primary Completion

December 27, 2018

Study Completion

December 27, 2018

Last Updated

March 26, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(5)AU(2)