Trial | NCT00949624  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    axitinib crenolanib docetaxel ...

  • Study Participants

    50
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.
Study Started
Dec 31
2005
Primary Completion
Jun 30
2008
Study Completion
Jun 30
2008
Last Update
Jan 19
2012
Estimate

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

Cohort 1 Experimental

60 mg BID/ 75 mg/m2

Cohort 2 Experimental

100 mg BID/75 mg/m2

Cohort 3 Experimental

100 mg BID/100 mg/m2

Cohort 4b Experimental

CP-868,596 + AG-013736 + TXT 75

Criteria 

Inclusion Criteria:

Be ≥18 years old and with histologically or cytologically confirmed advanced solid tumors refractory/resistant to currently available therapies or for which there is no standard therapy.
Patients with primary brain tumors are not eligible.
Have at least one site of measurable disease.

Exclusion Criteria:

Received chemotherapy (including targeted agents such as erlotinib), radiotherapy, immunotherapy or any investigational therapy within 3 weeks of study entry (within 6 weeks for previous treatments with nitrosoureas or mitomycin C).
Received tamoxifen within 4 weeks prior to study entry.
No Results Posted