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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
PubMed
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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:

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  • 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.