Selumetinib and Cyclosporine in Treating Patients With Advanced Solid Tumors or Advanced or Metastatic Colorectal Cancer

Part of paid clinical trials in Sacramento, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02188264
Phase
PHASE1
Status
Completed

Conditions

  • Recurrent Colorectal Carcinoma
  • Solid Neoplasm
  • Stage IIIA Colorectal Cancer AJCC v7
  • Stage IIIB Colorectal Cancer AJCC v7
  • Stage IIIC Colorectal Cancer AJCC v7
  • Stage IVA Colorectal Cancer AJCC v7
  • Stage IVB Colorectal Cancer AJCC v7

Eligibility Criteria

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

Interventions

  • Cyclosporine — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Selumetinib — DRUG
    Given PO

Study Details

This phase I/Ib trial studies the side effects and best dose of selumetinib when given together with cyclosporine in treating patients with solid tumors or colorectal cancer that have spread to other places in the body and cannot be cured or controlled with treatment. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as cyclosporine, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Giving selumetinib and cyclosporine may be a better treatment for solid tumors or colorectal cancer.

Key Dates

Start date
Aug 29, 2014
Status verified
Feb 2025
Primary completion
Jan 31, 2017
Completion
Apr 26, 2019

Study Design

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

Arms

  • Experimental: Treatment (selumetinib and cyclosporine)
    Patients receive selumetinib PO BID on day -7 of course 1 and then on days 1-28 (one dose on day 1 only). Patients also receive cyclosporine PO BID on day -3 of course 1 and then on days 1-28 (one dose on day 1 only). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of DLT defined as any grade 3 non-hematological toxicity or grade 4 hematological toxicity attributed to selumetinib or cyclosporine graded per National Cancer Institute (NCI) CTCAE version 4.0 [ Time Frame: 28 days ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UCHealth University of Colorado HospitalAuroraColorado80045-
Siteman Cancer Center at West County HospitalCreve CoeurMissouri63141-
Washington University School of MedicineSt LouisMissouri63110-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Sacramento, CA

By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CAUCHealth University of Colorado Hospital· Aurora, COSiteman Cancer Center at West County Hospital· Creve Coeur, MOWashington University School of Medicine· St Louis, MORutgers Cancer Institute of New Jersey· New Brunswick, NJUNC Lineberger Comprehensive Cancer Center· Chapel Hill, NC

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