Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01902173
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Locally Advanced Malignant Solid Neoplasm
  • Locally Advanced Melanoma
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Melanoma
  • Stage IIIC Cutaneous Melanoma AJCC v7
  • Stage IV Cutaneous Melanoma AJCC v6 and v7
  • Unresectable Malignant Solid Neoplasm
  • Unresectable Melanoma

Eligibility Criteria

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

Interventions

  • Biopsy — PROCEDURE
    Undergo a biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo a CT scan
  • Dabrafenib Mesylate — DRUG
    Given PO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Trametinib Dimethyl Sulfoxide — DRUG
    Given PO
  • Uprosertib — DRUG
    Given PO

Study Details

This phase I/II trial studies the side effects and the best dose of uprosertib when given together with dabrafenib and trametinib and to see how well they work in treating patients with stage IIIC-IV cancer. Uprosertib, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving uprosertib with dabrafenib and trametinib may be a better treatment for cancer.

Key Dates

Start date
Oct 8, 2013
Status verified
Dec 2024
Primary completion
May 16, 2018
Completion
Dec 23, 2023

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (uprosertib, dabrafenib, trametinib)
    Dabrafenib mesylate and uprosertib (Phase I): Patients receive dabrafenib PO BID and uprosertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, MRI, and blood sample collection throughout trial. Patients may also undergo a biopsy throughout the trial. Dabrafenib mesylate, trametinib dimethyl sulfoxide, and uprosertib (Phase I and Phase II): Patients receive dabrafenib PO BID, trametinib PO QD, and uprosertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, MRI, and blood sample collection throughout trial. Patients may also undergo a biopsy throughout the trial.

Primary Outcome Measure

Maximum-tolerated Dose (MTD) of Akt Inhibitor GSK2141795 in Combination With Dabrafenib. [ Time Frame: Every 2 weeks during days 1-56 of treatment. ]

Locations (16)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
California Pacific Medical Center-Pacific CampusSan FranciscoCalifornia94115-
UCSF Medical Center-Mount ZionSan FranciscoCalifornia94115-
UCHealth University of Colorado HospitalAuroraColorado80045-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Cleveland Clinic FoundationClevelandOhio44195-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Clackamas Radiation Oncology CenterClackamasOregon97015-
Providence Milwaukie HospitalMilwaukieOregon97222-
Providence Newberg Medical CenterNewbergOregon97132-
Providence Willamette Falls Medical CenterOregon CityOregon97045-
Oregon Health and Science UniversityPortlandOregon97239-
Providence Portland Medical CenterPortlandOregon97213-
Providence Saint Vincent Medical CenterPortlandOregon97225-
PeaceHealth Southwest Medical CenterVancouverWashington98664-

Find similar trials in Los Angeles, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CACalifornia Pacific Medical Center-Pacific Campus· San Francisco, CAUCSF Medical Center-Mount Zion· San Francisco, CAUCHealth University of Colorado Hospital· Aurora, COUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MI

Related Studies