NCT00949624

CP-868,596 And CP-868,596 Plus AG-013736 In Combination With Docetaxel In Advanced Solid Tumors

Phase I Study To Determine The Maximally Tolerated Dose Of Oral, Daily CP-868,596 And CP-868,596 Plus AG-013736 When Given In Combination With Docetaxel Administered Every 3 Weeks To Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Arog Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A5301005 is a phase 1 study in patients with solid tumors which is testing the safety and tolerability of adding targeted agents to a standard chemotherapy. CP-868,596 is a platelet-derived growth factor receptor inhibitor (PDGFR) and AG-13736 is a vascular endothelial growth factor receptor inhibitor (VEGFR). This study will test the use of docetaxel (the standard chemotherapy) with either CP-868,596 or the combination of CP-868,596 and AG-13736.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	CP-868,596	Oral tablet 60 mg BID continuous
DRUG	Docetaxel	Intravenous 75 mg/m2 every three weeks
DRUG	CP-868,596	Oral tablet 100 mg BID continuous
DRUG	Docetaxel	Intravenous 75 mg/m2 every three weeks
DRUG	CP-868,596	Oral tablet 100 mg BID continuous
DRUG	Docetaxel	Intravenous 100 mg/m2 every three weeks
DRUG	CP-868,596	Oral tablet 60 mg BID continuous
DRUG	AG-013736	Oral tablet 5 mg BID continuous
DRUG	Docetaxel	Intravenous 75 mg/m2 every three weeks

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2009-07-30
• Last updated: 2012-01-19

Locations

2 sites across 2 countries: United States, Australia