Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01364051
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Metastatic Melanoma
  • Refractory Malignant Solid Neoplasm
  • Stage IV Cutaneous Melanoma AJCC v6 and v7
  • Unresectable Malignant Solid Neoplasm

Eligibility Criteria

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

Interventions

  • Cediranib — DRUG
    Given PO
  • Cediranib Maleate — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Selumetinib — DRUG
    Given PO
  • Selumetinib Sulfate — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and best dose of cediranib maleate and selumetinib sulfate in treating patients with solid malignancies. Cediranib maleate and selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may also stop the growth of tumor cells by blocking blood flow to the tumor.

Key Dates

Start date
May 25, 2011
Status verified
Mar 2026
Primary completion
Jun 6, 2019
Completion
Mar 31, 2027

Study Design

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

Arms

  • Experimental: Treatment (cediranib maleate, selumetinib)
    Patients receive cediranib maleate PO QD and selumetinib sulfate PO QD or BID on days 1-28 (days 8-28 of cycle 1). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cycles may be extended to 12 weeks after 1 year of study treatment.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: 28 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Mayo Clinic in RochesterRochesterMinnesota55905-

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