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SPRYCEL Clinical Trials
The clinical trial programme for SPRYCEL included 4 non-randomised, single-arm, phase II trials; an open-label, randomised, non-comparative, phase II trial of SPRYCEL and high-dose imatinib; and 2 randomised, controlled, phase III dose optimisation trials.
SPRYCEL Chronic Phase CML Trial (100 mg)
Study 034 Design: Open-label phase III trial in which 670 patients with imatinib-resistant or -intolerant chronic phase chronic myeloid leukaemia (CP-CML) were randomly assigned 1:1:1:1 between four dasatinib treatment groups: 100 mg once daily, 50 mg twice daily, 140 mg once daily, or 70 mg twice daily.
Primary Endpoint: The rate of MCyR in patients with imatinib resistance, with a minimum follow-up of 6 months.
SPRYCEL or Higher-Dose Imatinib Trial (START-R)
START-R Study Design: Randomised, international, open-label, phase II study of patients with chronic phase chronic myeloid leukaemia (CML) resistant to imatinib (400-600 mg/day). Patients were randomised on a 2:1 basis to SPRYCEL 140 mg (70 mg BID)* or imatinib 800 mg (400 mg BID).
Primary Endpoint: Major cytogenetic response (MCyR).
View the trial results.
SPRYCEL Advanced Phase CML Trial (140 mg)
Study 035 Design: International, multicenter, randomised, open-label, phase III study in which 611 patients with imatinib-resistant or -intolerant advanced-phase chronic myeloid leukaemia (CML) were randomly assigned 1:1 between two dasatinib treatment groups: 140 mg once daily or 70 mg twice daily.
Primary Objective: To estimate major haematologic response* (MaHR) rates with QD and BID treatment.
SPRYCEL Safety Summary
Safety data were collected from >2,100 patients exposed to SPRYCEL in clinical studies.
View summary.
Disclaimer: This is an international Web site for SPRYCEL® (dasatinib) and is intended for healthcare professionals outside the U.S.
If you are a U.S. resident, please visit www.SPRYCEL.com.
If you are not a healthcare professional, please visit www.BMS.com.
The information on this site is not country-specific and may contain information that is outside the approved indications in the country in which you are located or practice.