Refractory Malignancy Clinical Trial
Official title:
A Phase I Pharmacokinetic and Safety Study of Sorafenib + Capecitabine in Advanced Solid Tumors
This is a phase I, randomized, safety and pharmacokinetic (PK) study of sorafenib given in combination with capecitabine. The study will enroll two simultaneous cohorts; patients will be randomly assigned to either Cohort A or Cohort B. A third cohort (C) may be added to the protocol at a later date.
During Cycle 1, patients will receive capecitabine alone for the first 7 days (Cohort A will
receive 750 mg/m2 of capecitabine twice daily, and Cohort B will receive 1000 mg/m2 of
capecitabine twice daily for the first 7 days of Cycle 1). For days 8-14 of Cycle 1,
patients will receive capecitabine (750 mg/m2 twice daily for Cohort A; 1000 mg/m2 twice
daily for Cohort B) combined with sorafenib (400 mg twice daily for both cohorts); on days
15-21 of Cycle 1, patients will receive sorafenib alone (400 mg twice daily for both
cohorts). Beginning with day 1 of Cycle 2 and all treatment cycles thereafter, patients will
be dosed as follows: Cohort A will receive sorafenib orally at 400 mg twice daily for 21
days, and capecitabine orally at 750 mg/m2 twice daily for the first 14 days of a 21-day
treatment cycle.
Cohort B will receive sorafenib orally at 400 mg twice daily for 21 days, and capecitabine
orally at 1000 mg/m2 twice daily for the first 14 days of a 21-day treatment cycle. After 6
patients each are enrolled into Cohort A and Cohort B, one of these two cohorts will enroll
an additional 6-12 patients in an expansion phase.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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