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Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies

Phase I Study of the Combination of the VEGFR Inhibitor, AZD2171, and MEK Inhibitor, AZD6244, in the Treatment of Solid Malignancies

NCT01364051•National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose of cediranib maleate (AZD2171 \[cediranib\]) in combination with selumetinib sulfate (AZD6244 hydrogen sulfate). II. To describe the toxicity profile associated with AZD2171 (cediranib) in combination with AZD6244 hydrogen sulfate. III. To describe the tumor responses and identify any activity of this AZD2171 (cediranib) in combination with AZD6244 hydrogen sulfate. IV. To explore, through correlative studies, the effect of AZD2171 (cediranib) with or without AZD6244 hydrogen sulfate on serum markers of apoptosis. V. To assess the pharmacokinetic interaction of AZD2171 (cediranib) in combination with AZD6244 hydrogen sulfate. VI. To study the association of clinical (toxicity and/or tumor response or activity) with the pharmacologic (pharmacokinetic/pharmacodynamic) parameters, and/or biologic (correlative laboratory study) results. OUTLINE: This is a dose-escalation study followed by a dose-expansion cohort study. Patients receive cediranib maleate orally (PO) once daily (QD) and selumetinib sulfate PO QD or twice daily (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. After completion of study therapy, patients are followed up at 3 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)
+6 more criteria

Exclusion Criteria

•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
+22 more criteria

Locations (2)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

May 25, 2011

Primary Completion Date

June 6, 2019

Completion Date

March 19, 2026

Last Updated

March 20, 2026

Enrollment

ACTUAL participants

Conditions

Metastatic MelanomaRefractory Malignant Solid NeoplasmStage IV Cutaneous Melanoma AJCC v6 and v7Unresectable Malignant Solid Neoplasm

Interventions

Cediranib

DRUG

Cediranib Maleate

DRUG

Laboratory Biomarker Analysis

OTHER

Pharmacological Study

OTHER

Selumetinib

DRUG

Selumetinib Sulfate

DRUG

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

NCT05053971

Advanced Malignant Solid NeoplasmLocally Advanced Pancreatic Carcinoma+7 more

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RECRUITINGPHASE1

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

NCT06066138

Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies

Inclusion Criteria

Exclusion Criteria

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma

STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers

Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis

Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors