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Sunitinib in combination with gemcitabine for advanced solid tumours: a phase I dose-finding study
M D Michaelson1, A X Zhu, D P Ryan
1Massachusetts General Hospital Cancer Center, 55 Fruit Street, Yawkey 7, Boston, MA 02114, USA. dmichaelson1@partners.org
British Journal of Cancer
|March 21, 2013
Summary
Sunitinib combined with gemcitabine showed promising antitumor activity in advanced solid tumors. The combination was well-tolerated and safely administered at maximum doses, with no significant drug interactions observed.
Area of Science:
- Oncology
- Clinical Pharmacology
- Drug Development
Background:
- Phase I dose-finding study of sunitinib plus gemcitabine in advanced solid tumors.
- Investigated safety, pharmacokinetics, and maximum tolerated dose (MTD).
Purpose of the Study:
- Determine the MTD, safety, and pharmacokinetics of sunitinib plus gemcitabine.
- Evaluate two different dosing schedules for the combination therapy.
Main Methods:
- Two schedules evaluated: sunitinib (25-50 mg/day) with gemcitabine (750-1250 mg/m²).
- Schedule 4/2: sunitinib 4 weeks on/2 weeks off; gemcitabine days 1, 8, 22, 29.
- Schedule 2/1: sunitinib 2 weeks on/1 week off; gemcitabine days 1, 8.
Main Results:
- 44 patients treated (Schedule 4/2, n=8; Schedule 2/1, n=36).
- MTD not reached on Schedule 2/1 due to absence of dose-limiting toxicities.
- Observed antitumor activity, including responses in renal cell carcinoma patients.
Conclusions:
- Sunitinib plus gemcitabine on Schedule 2/1 was well-tolerated and safely administered at maximum doses.
- No clinically significant drug-drug interactions were identified.
- Combination therapy demonstrated antitumor activity in advanced solid tumors.
