18 and older, any sex, with Recurrent Renal Cell Carcinoma or Stage III Renal Cell Cancer AJCC v7. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response for BAY 43-9006 in Combination With Gemcitabine and Capecitabine Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)Primary· Up to 9 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR
Group
Value
95% CI
Sorafenib + Gemcitabine + Capecitabine
5
Median Number of Months of Progression Free Survival (PFS)Secondary· From the time of the patient's initial best response (PR or CR) until documented progression, assessed up to 9 years
PFS will be measured from the time of the patient's initial best response (PR or CR) until documented progression.
Group
Value
95% CI
Sorafenib + Gemcitabine + Capecitabine
5
3 – 17
Number of Participants Who Survived (Overall Survival)Secondary· Up to 9 years
Overall survival (OS) is defined as the time from start of treatment to death from any cause.
Group
Value
95% CI
Sorafenib + Gemcitabine + Capecitabine
6
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 9 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase I/II trial is studying the side effects and best dose of sorafenib, gemcitabine, and capecitabine and to see how well they work in treating patients with unresectable and/or metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with gemcitabine and capecitabine may kill more tumor cells.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Other recruiting trials for Recurrent Renal Cell Carcinoma
Currently open trials in the same condition.
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Other National Cancer Institute (NCI) trials
Trials by the same sponsor.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 6 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00121251.