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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Kartos Therapeutics, Inc.
Study ID
NCT02110355
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Malignancy
  • Advanced Solid Tumors
  • Cancer
  • Melanoma
  • Oncology
  • Oncology Patients
  • Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AMG 232 — DRUG
    Given as an oral tablet in escalating doses
  • Trametinib — DRUG
    Trametinib is an anti-cancer agent
  • Dabrafenib — DRUG
    Dabrafenib is an anti-cancer agent

Study Details

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.

Key Dates

Start date
Dec 19, 2014
Status verified
Mar 2021
Primary completion
Dec 27, 2018
Completion
Dec 27, 2018

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

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 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90095-
Research SiteAuroraColorado80045-
Research SiteBostonMassachusetts02114-
Research SiteChapel HillNorth Carolina27599-
Research SiteNashvilleTennessee37232-

Find similar trials in Los Angeles, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Research Site· Los Angeles, CAResearch Site· Aurora, COResearch Site· Boston, MAResearch Site· Chapel Hill, NCResearch Site· Nashville, TN

Related Studies