Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies

Running, not enrolling · Phase 1

Conditions studied: Metastatic Melanoma, Refractory Malignant Solid Neoplasm, Stage IV Cutaneous Melanoma AJCC v6 and v7, Unresectable Malignant Solid Neoplasm

In brief

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 facts

Study ID

NCT01364051

Run by

National Cancer Institute (NCI)

People needed

19

Starts

2011-05-25

Expected to finish

2027-03-31

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 tumor tissue for correlative research purposes

You may not qualify if…

• Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Any of the following prior therapies:
• Chemotherapy =< 28 days prior to registration
• Mitomycin C/nitrosoureas =< 42 days prior to registration
• Immunotherapy =< 28 days prior to registration
• Biologic therapy =< 28 days prior to registration
• Radiation therapy =< 28 days prior to registration
• Radiation to > 25% of bone marrow
• Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
• Cardiac conditions as follows:
• Uncontrolled hypertension (blood pressure [BP] >= 150/95 despite optimal therapy)
• Heart failure New York Heart Association (NYHA) class II or above or left ventricular ejection fraction < 50%
• Atrial fibrillation with heart rate > 100 beats per minute (bpm)
• Unstable ischemic heart disease (myocardial infarction [MI] within 6 months prior to starting treatment, or angina requiring use of nitrates more than once weekly)
• Patients who require concomitant agents that prolong corrected QT interval (QTc)
• Known brain or central nervous system (CNS) metastases without definitive therapy; patients who have received definitive therapy for CNS lesions may be considered if there is no evidence of progression on computed tomography (CT) or magnetic resonance imaging (MRI) imaging obtained 3 months apart
• Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation)
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Immunocompromised patients (other than that related to the use of corticosteroids) with the exception of patients known to be human immunodeficiency virus [HIV] positive and have a cluster of differentiation [CD]4 count > 400 and do not require antiretroviral therapy
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm

Where it is running

• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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