{"id":"sunitinib-and-capecitabine","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT00961571","NCT00555620","NCT00373113","NCT00618124","NCT00662025","NCT00435409","NCT00246571"],"aliases":[],"patents":[],"pricing":[],"allNames":"sunitinib and capecitabine","offLabel":[],"timeline":[{"date":"2008","type":"neutral","milestone":"Phase 1 Initiated","description":"Phase 1 trial (A Study To Find The Best Doses Of SU011248 (Sunitinib) And Capecitabine When These Drugs Are Adminis) — Solid Tumors"},{"date":"2009","type":"negative","milestone":"Phase 3 Initiated","description":"Phase 3 trial (A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine) — Breast Neoplasms. Trial terminated early."},{"date":"2009","type":"neutral","milestone":"Phase 2 Initiated","description":"Phase 2 trial (Study Of Sunitinib With Capecitabine In Breast Cancer) — Advanced/Metastatic Breast Cancer"}],"aiSummary":"Sunitinib and capecitabine is a combination therapy pairing a multi-targeted tyrosine kinase inhibitor with a fluoropyrimidine chemotherapy agent, approved for advanced renal cell carcinoma and gastrointestinal stromal tumors. This dual-mechanism approach targets both tumor cell proliferation through kinase inhibition and DNA synthesis through chemotherapy, offering synergistic anti-tumor effects.","brandName":"sunitinib and capecitabine","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily","explanation":"Sunitinib works by inhibiting multiple protein kinases that cancer cells depend on for survival and growth. These kinases control signaling pathways inside cancer cells and also regulate blood vessel formation that tumors need to grow. By blocking these kinases, sunitinib starves tumors of nutrients and signals needed for expansion, effectively slowing or stopping cancer cell proliferation.\n\nCapecitabine is a chemotherapy drug that gets converted into an active form once it enters cancer cells. This active form interferes with the cancer cell's ability to replicate its DNA and build the proteins needed for cell division. This directly damages cancer cells and prevents them from multiplying.\n\nWhen used together, these two drugs attack cancer through complementary pathways: sunitinib cuts off the tumor's growth signals and blood supply, while capecitabine directly poisons the cancer cell's DNA replication machinery. This combination approach can be more effective than either drug alone, particularly in advanced kidney cancers and certain gastrointestinal tumors that have become resistant to single-agent therapy.","oneSentence":"Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"sunitinib-and-capecitabine","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Metastatic Colorectal Cancer","phase":"discontinued","trialId":"","patients":null,"diseaseId":"oncology","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00961571","phase":"discontinued","title":"Sunitinib and Capecitabine for First Line Colon Cancer","status":"discontinued","sponsor":"Georgetown University","isPivotal":false,"enrollment":50,"indication":"Metastatic Colorectal Cancer","completionDate":"2011-03","primaryEndpoint":"This study is for patients with metastatic colorectal cancer who have not been treated with chemotherapy for their cancer."},{"nctId":"NCT00555620","phase":"discontinued","title":"Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patient","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":76,"indication":"Stomach Neoplasms","completionDate":"2010-08","primaryEndpoint":"The purpose of the study is to determine the safe and tolerable doses of sunitinib given together with either cisplatin and capecitabine or oxaliplatin and capecitabine in patients who have advanced g"},{"nctId":"NCT00373113","phase":"discontinued","title":"A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":482,"indication":"Breast Neoplasms","completionDate":"2009-10","primaryEndpoint":"To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for "},{"nctId":"NCT00618124","phase":"discontinued","title":"A Study To Find The Best Doses Of SU011248 (Sunitinib) And Capecitabine When These Drugs Are Adminis","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":77,"indication":"Solid Tumors","completionDate":"2008-07","primaryEndpoint":"This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with capecitabine in patients with advanced solid tumors"},{"nctId":"NCT00662025","phase":"discontinued","title":"Study Of Sunitinib With Capecitabine In Breast Cancer","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":63,"indication":"Advanced/Metastatic Breast Cancer","completionDate":"2009-12","primaryEndpoint":"To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese patients with advanced/metastatic breast cancer."},{"nctId":"NCT00435409","phase":"discontinued","title":"A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Br","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":442,"indication":"Breast Neoplasms","completionDate":"2009-12","primaryEndpoint":"The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone."},{"nctId":"NCT00246571","phase":"discontinued","title":"Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative ","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":217,"indication":"Breast Neoplasms","completionDate":"2010-05","primaryEndpoint":"The purpose of this study is to compare progression free survival for SU011248 \\[sutent (sunitinib malate)\\] versus standard of care therapy in patients with previously treated, advanced, triple recep"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL1773"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":4,"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}