29:I[164923,["/_next/static/immutable/chunks/0x-9rc1bm-510.js","/_next/static/immutable/chunks/0u73ovrok9bmr.js","/_next/static/immutable/chunks/3t9ifrnugpnlb.js","/_next/static/immutable/chunks/3gdp0tzp2t65u.js","/_next/static/immutable/chunks/0qexc5596g7lf.js","/_next/static/immutable/chunks/3nkl8euu6dycn.js","/_next/static/immutable/chunks/28p3k9kvs3dfa.js","/_next/static/immutable/chunks/04j_o97cgxn2x.js","/_next/static/immutable/chunks/18bybpoq919w1.js"],"ClinicalTrialDetail"] 28:T9a1,{"@context":"https://schema.org","@type":"FAQPage","mainEntity":[{"@type":"Question","name":"What are the potential side effects of cediranib and selumetinib?","acceptedAnswer":{"@type":"Answer","text":"This is a question you may want to discuss with your doctor regarding the Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies clinical trial (NCT01364051). Contact the study team or your healthcare provider for specific answers."}},{"@type":"Question","name":"How will this trial compare to my current treatment options?","acceptedAnswer":{"@type":"Answer","text":"This is a question you may want to discuss with your doctor regarding the Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies clinical trial (NCT01364051). Contact the study team or your healthcare provider for specific answers."}},{"@type":"Question","name":"What is the expected duration of my participation in this trial?","acceptedAnswer":{"@type":"Answer","text":"This is a question you may want to discuss with your doctor regarding the Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies clinical trial (NCT01364051). Contact the study team or your healthcare provider for specific answers."}},{"@type":"Question","name":"How often will I need to come in for visits and tests?","acceptedAnswer":{"@type":"Answer","text":"This is a question you may want to discuss with your doctor regarding the Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies clinical trial (NCT01364051). Contact the study team or your healthcare provider for specific answers."}},{"@type":"Question","name":"What happens if I experience side effects during the trial?","acceptedAnswer":{"@type":"Answer","text":"This is a question you may want to discuss with your doctor regarding the Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies clinical trial (NCT01364051). Contact the study team or your healthcare provider for specific answers."}},{"@type":"Question","name":"Will I need to provide any samples for research purposes?","acceptedAnswer":{"@type":"Answer","text":"This is a question you may want to discuss with your doctor regarding the Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies clinical trial (NCT01364051). Contact the study team or your healthcare provider for specific answers."}}]}25:["$","script","3",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"$28"}}] 2a:T56a,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.2b:T16b0,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 tumor tissue for correlative research purposes 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 * 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 * Other active malignancy =\< 3 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment (i.e. hormonal therapy) for their cancer * Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart unless urinary protein \< 1.5g in a 24 hour (hr) period or urine protein/creatinine ratio \< 1.5 * History of exposure to AZD2171 (cediranib), AZD6244 hydrogen sulfate, or mitogen-activated protein kinase kinase (MEK), retrovirus-associated deoxyribonucleic acid (DNA) sequence (Ras) or v-RAF-1 murine leukemia viral oncogene homolog (Raf) inhibitors (sorafenib); Note: prior therapy with bevacizumab, sunitinib, pazopanib or aflibercept (vascular endothelial growth factor \[VEGF\] Trap) are allowed * Surgery within two weeks prior to registration * Significant hemorrhage (\> 30 mL bleeding/episode in previous 3 months) or hemoptysis (\> 5 mL fresh blood in previous 4 weeks) * Mean QTc interval with Bazetts correction \> 480 msec (Common Toxicity Criteria \[CTC\] grade 1) in screening electrocardiogram (ECG) or history of familial long QT syndrome * Patients who are unable to swallow tablets and capsules26:["$","$L29",null,{"trial":{"nctId":"NCT01364051","briefTitle":"Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies","officialTitle":"Phase I Study of the Combination of the VEGFR Inhibitor, AZD2171, and MEK Inhibitor, AZD6244, in the Treatment of Solid Malignancies","briefSummary":"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.","detailedDescription":"$2a","overallStatus":"ACTIVE_NOT_RECRUITING","phase":"PHASE1","studyType":"INTERVENTIONAL","conditions":["Metastatic Melanoma","Refractory Malignant Solid Neoplasm","Stage IV Cutaneous Melanoma AJCC v6 and v7","Unresectable Malignant Solid Neoplasm"],"interventions":[{"type":"DRUG","name":"Cediranib","description":"Given PO"},{"type":"DRUG","name":"Cediranib Maleate","description":"Given PO"},{"type":"OTHER","name":"Laboratory Biomarker Analysis","description":"Correlative studies"},{"type":"OTHER","name":"Pharmacological Study","description":"Correlative studies"},{"type":"DRUG","name":"Selumetinib","description":"Given PO"},{"type":"DRUG","name":"Selumetinib Sulfate","description":"Given PO"}],"keywords":null,"locations":[{"facility":"Mayo Clinic in Florida","city":"Jacksonville","state":"Florida","country":"United States","zip":"32224-9980","lat":30.33218,"lng":-81.65565},{"facility":"Mayo Clinic in Rochester","city":"Rochester","state":"Minnesota","country":"United States","zip":"55905","lat":44.02163,"lng":-92.4699}],"eligibilityCriteria":"$2b","minAge":18,"maxAge":null,"sex":"ALL","healthyVolunteers":false,"leadSponsor":"National Cancer Institute (NCI)","collaborators":null,"contacts":null,"startDate":"$D2011-05-25T00:00:00.000Z","completionDate":"$D2027-03-31T00:00:00.000Z","primaryCompletionDate":"$D2019-06-06T00:00:00.000Z","firstPostDate":"$D2011-06-02T00:00:00.000Z","lastUpdatePostDate":"$D2026-09-10T00:00:00.000Z","enrollmentCount":19,"enrollmentType":"ACTUAL","aiSummary":{"summary":"This clinical trial is testing two drugs, cediranib maleate and selumetinib sulfate, to see how well they work together in treating patients with solid tumors that cannot be surgically removed. It is specifically for people with advanced melanoma and other types of malignant solid tumors who have no standard treatment options available.","version":2,"mainIdea":"Finding the best dose and understanding side effects","studyAbout":"This clinical trial is testing two drugs, cediranib maleate and selumetinib sulfate, to see how well they work together in treating patients with solid tumors that cannot be surgically removed. It is specifically for people with advanced melanoma and other types of malignant solid tumors who have no standard treatment options available.","comparedWith":null,"mayQualifyIf":["You have advanced melanoma or another type of solid tumor that cannot be surgically removed.","Your cancer has not responded to standard treatments.","You are looking for new treatment options and are willing to participate in a clinical trial."],"newTreatment":"Cediranib Maleate and Selumetinib Sulfate","lessRelevantIf":["You have a type of cancer for which there is a standard treatment that could help.","You have had recent chemotherapy or radiation therapy within the last month.","You have certain heart conditions or uncontrolled health issues that could complicate treatment."],"questionsToAsk":["What are the potential side effects of cediranib and selumetinib?","How will this trial compare to my current treatment options?","What is the expected duration of my participation in this trial?","How often will I need to come in for visits and tests?","What happens if I experience side effects during the trial?","Will I need to provide any samples for research purposes?"],"careConversation":"This trial could be an option for patients with advanced solid tumors who have exhausted standard treatment options. It's important to discuss how this trial fits into your overall treatment plan, including potential side effects, the logistics of participation, and how it aligns with your personal health goals and preferences.","worthDiscussingIf":["You have advanced melanoma or another type of solid tumor that cannot be surgically removed.","Your cancer has not responded to standard treatments.","You are looking for new treatment options and are willing to participate in a clinical trial."],"likelyWontQualifyIf":["You have a type of cancer for which there is a standard treatment that could help.","You have had recent chemotherapy or radiation therapy within the last month.","You have certain heart conditions or uncontrolled health issues that could complicate treatment."],"participationBullets":["Participants will take cediranib maleate and selumetinib sulfate orally every day.","Regular blood tests and monitoring will be done to check for side effects and treatment effectiveness.","Patients will need to return to the clinic for follow-up after completing the treatment.","Participants may need to provide blood samples and tumor tissue for research purposes."],"participationDetails":{"visitRhythm":"Every 28 days for treatment cycles, with follow-up visits after 3 months.","treatmentLength":"Cycles may continue until disease progression or unacceptable toxicity, potentially extending up to 12 weeks after 1 year.","participationCycles":"Cycles repeat every 28 days."},"whatParticipatingInvolves":["Participants will take cediranib maleate and selumetinib sulfate orally every day.","Regular blood tests and monitoring will be done to check for side effects and treatment effectiveness.","Patients will need to return to the clinic for follow-up after completing the treatment.","Participants may need to provide blood samples and tumor tissue for research purposes."]},"aiSummaryGeneratedAt":"$D2026-09-10T21:50:59.876Z","id":"068d824c-7e91-4463-b9a9-f351a4de5a88","createdAt":"$D2026-03-22T19:11:02.084Z","updatedAt":"$D2026-04-27T05:33:46.808Z"}}]

What this study is about