Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies (NCT01364051) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies
United States19 participantsStarted 2011-05-25
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologic proof of cancer that is now considered clinically unresectable and for whom there is no standard therapy; NOTE: for the maximum tolerated dose (MTD) expansion cohort only: metastatic melanoma histology is required
* Measurable and non-measurable disease are eligible
* Ability to provide informed consent
* Absolute neutrophil count (ANC) \>= 1500/uL (obtained =\< 21 days prior to registration)
* Platelets (PLT) \>= 100,000/uL (obtained =\< 21 days prior to registration)
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) (obtained =\< 21 days prior to registration)
* Aspartate aminotransferase (AST) =\< 2.5 x ULN or =\< 5 x ULN in presence of liver metastases (obtained =\< 21 days prior to registration)
* Creatinine =\< 1.5 x ULN (obtained =\< 21 days prior to registration)
* Hemoglobin (HgB) \>= 9.0 gm/dL (obtained =\< 21 days prior to registration)
* Alkaline phosphatase =\< 2.5 x ULN (obtained =\< 21 days prior to registration)
* Creatinine clearance \> 50 ml/min, by either Cockcroft-Gault formula or 24-hour urine collection analysis (obtained =\< 21 days prior to registration)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1
* Willing to return to Mayo for follow up
* Life expectancy \>= 12 weeks
* Women of childbearing potential only: negative serum pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
* Expansion phase only: willing to provide blood samples and archived…