Abstract
3059 Background: With its potent inhibitory effects against Raf-1 kinase and VEGFR-2, BAY 43–9006 (BAY) is a novel oral anticancer agent targeting signal transduction and angiogenic pathways. This study is designed to combine BAY and gemcitabine (GEM) due to their compatibility in preclinical models and non-overlapping clinical toxicities. Methods: An initial dose-escalating phase enrolled patients (pts) with advanced solid tumors, followed by an extended phase at the recommended dose (RD) for pts with advanced unresectable or metastatic pancreatic cancer. BAY is administered continuously while GEM is given at 1000 mg/m2 weekly x 7 followed by 1 rest week, then weekly x 3 every 4 weeks. Results: Forty-two pts have been enrolled with the following demographics: M:F ratio = 26:16; median age = 61 (range 39–83); ECOG 0:1:2:missing ratio = 17:19:5:1. Nineteen of the 42 pts were enrolled in the dose-escalating phase, the majority had ovarian (6 pts) or colorectal (5 pts) primaries, and 16/19 pts have had prior chemotherapy. In the extended phase, 23 pts with pancreatic cancer were enrolled, and all but 1 pt were chemonaive. The RD of this combination is BAY 400 mg BID and GEM 1000 mg/m2. Preliminary analyses of Gr ≥ 3 toxicities are summarized below. Gr 1/2 rises in transaminases, hematological toxicity, fatigue, hand-foot skin reaction and rash were common, but were clinically tolerable. Antitumor activity has been observed: 2 confirmed PR (ovarian cancer), and 12 SD, among which 2 pts remained on study for >1 yr in the dose-escalating phase; 1 unconfirmed PR and 11 SD in the pancreatic cohort. Pharmacokinetic data showed a lack of interaction between BAY and GEM. Conclusions: BAY and GEM appear well tolerated in combination, and further evaluations of this combination in pancreatic and ovarian cancers are warranted. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bayer, Inc.
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