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• W2079571738 abstract "Abstract Background: ABT-869 is a novel orally active, potent and selective inhibitor of VEGF and PDGF receptor tyrosine kinases. ABT-869 potentiates the action of P in a number of preclinical tumor models including breast carcinoma (BC). This study was conducted to assess pharmacokinetic (PK) interaction and safety of ABT-869 combined with weekly P, and to guide ABT-869 dosing in the randomized portion of the trial.Methods: Pts with measurable chemotherapy naïve metastatic or unresectable locally advanced BC were eligible for this trial. Treatment consisted of weekly P (90 mg/m2) on Day (D) 1, 8 and 15 of every 28-day cycle (C) and ABT-869 0.20 orally once daily (QD) starting on D3 of C1. Treatment continued until progressive disease (PD) or unacceptable toxicity was observed. CT scans were conducted at baseline (within 21 days prior to C1 D1) and at the end of every 3 cycles. Adverse events (AE) were graded by NCI CTCAE V3.0; efficacy was evaluated by RECIST.Results: As of May 2009, 8 pts have enrolled in this study: 5 at 0.20 mg/kg and, based on the frequent need for dose reductions in this and other ongoing trials, a second cohort has enrolled 3 out of 6 planned pts at 0.15 mg/kg. Preliminary safety and efficacy results are shown (table). Of the 5 pts dosed at 0.20 mg/kg, 2 pts had confirmed partial responses (PR) and continued on drug at reduced dose for 12 and 10 cycles, and 3 discontinued (DC); 1 due to PD, 1 withdrew consent, and 1 for AE (pulmonary embolism, cycle 2). Three pts have been dosed at 0.15 mg/kg; one is early and two have PR. The most common AEs were neutropenia (n=3), stomatitis, vomiting, ALT increased, hyperglycemia, hypokalemia and hypertension (n=2 each). These events were generally grade 1 or 2 except for neutropenia.Conclusion: The combination of ABT-869 0.20 mg/kg QD with P weekly resulted in antitumor activity (2 PR) but required frequent dose reductions due to AEs. A reduced dose of 0.15 mg/kg with weekly P is being evaluated (2 PR). Updated results of this ongoing study will be presented.Pt #Initial ABT-869 Dose (mg)Current ABT-869 Dose (mg)Cycle of Dose ReductionReason for Dose ReductionEnd Cycle 3 AssessmentsEnd Cycle 6 AssessmentsCurrent status 0.20 mg/kg 1001107.54G3 hand-footPRPRCycle 121041105.03,5G3 fatiguePRPRCycle 1010022020----DC in Cycle 2 (PD)102112.512.5--SD-DC in Cycle 4 (withdrew consent due to headaches)10221515----DC in Cycle 2 (Pulmonary embolism) 0.15 mg/kg 10231052,4G2 hand painPR-Cycle 510247.57.5--PR-Cycle 410251010----Cycle 1G= grade Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 5076." @default.
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• W2079571738 date "2009-12-01" @default.
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• W2079571738 title "ABT-869 in Combination with Paclitaxel (P) as First-Line Treatment in Patients (Pts) with Advanced Breast Cancer." @default.
• W2079571738 doi "https://doi.org/10.1158/0008-5472.sabcs-09-5076" @default.
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