GYN 4: phase I study of BIBF 1120 in combination with paclitaxel/carboplatin in patients with advanced gynecological malignancies

Aims: BIBF 1120 is an angiokinase inhibitor targeting VEGFR, PDGFR, FGFR kinases. Maximal tolerated dose (MTD), safety, and pharmacokinetics (PK) of twice daily BIBF 1120 in combination with carboplatin AUC 5 and paclitaxel 175mg/m² q21 (CP) was evaluated in advanced gynecological malignancies. Methods: 6 courses of CP and escalating bid doses of BIBF 1120 (2×100mg to 2×250mg) on the days without i.v. chemotherapy were administered. A 3+3 dose escalation design was followed. Additionally, 6 pts were treated on the MTD level. Results: Twenty-two pts were treated with at least one cycle of CP and BIBF 1120. At 2×2…