NCT00388427

Safety Study Of Cetuximab Plus Dasatinib (BMS-354825) in Treating Advanced Solid Malignancies

Phase I Study of Cetuximab Plus Dasatinib (BMS-354825) in Advanced Solid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, safety study of cetuximab and differing dose levels of dasatinib in adult patients with advanced solid malignancies. Cetuximab will be administered as an intravenous infusion weekly. Dasatinib will be taken orally, once a day, on a continuous schedule at differing dose levels. The primary objective of this study is to determine the toxicities and the maximum tolerated doses of dasatinib when combined with cetuximab for the treatment of advanced solid tumors.

Detailed description

This is an open-label, phase I study of cetuximab and differing dose levels of dasatinib in adult patients with advanced solid malignancies. Cetuximab will be administered as an intravenous infusion on a standard dose and schedule (weekly, with the first dose at 400 mg/m2 and all subsequent weekly doses at 250 mg/m2). Dasatinib will be administered orally on a continuous schedule at the following dose levels: 100 mg QD (once a day), 150 mg QD, and 200 mg QD. Three to six patients will be enrolled at each dose level, and the final recommended phase II cohort will be expanded to include up to 12 additional patients. The doses will be escalated in successive cohorts of patients. On cycle 1, dasatinib administration will start one day prior to cetuximab administration. One cycle will be defined as 21 days, and cycles will continue until progression of disease or intolerable toxicities occur. Peripheral blood samples and pharmacokinetic blood samples will be taken on days 0, 1, 15, and 16 of Cycle 1 only. In patients with accessible tumor that give consent, patients will undergo a baseline tumor biopsy and a repeat biopsy after 14-21 days of the first cycle.

Conditions

• Malignant Solid Tumour

Interventions

Type	Name	Description
DRUG	Dasatinib (BMS-354825)	100 mg, 150 mg, or 200 mg per dose escalation schedule; continuous oral dosing on Days 1-21 of each 21-day cycle until progression or unacceptable toxicity develops.
DRUG	Cetuximab (Erbitux, C225)	Loading dose of IV 400 mg/m\^2 on Day 1 of Cycle 1; IV 250 mg/m\^2 weekly thereafter each 21-day cycle until progression or unacceptable toxicity develops.

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-07-01
• Completion: 2013-02-01
• First posted: 2006-10-16
• Last updated: 2015-05-28

Locations

1 site across 1 country: United States