CP-868,596 And CP-868,596 Plus AG-013736 In Combination With Docetaxel In Advanced Solid Tumors
Phase 1
Completed
- Conditions
- Advanced Solid Tumors
- Interventions
- Registration Number
- NCT00949624
- Lead Sponsor
- Arog Pharmaceuticals, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 4b CP-868,596 CP-868,596 + AG-013736 + TXT 75 Cohort 1 CP-868,596 60 mg BID/ 75 mg/m2 Cohort 1 Docetaxel 60 mg BID/ 75 mg/m2 Cohort 2 CP-868,596 100 mg BID/75 mg/m2 Cohort 2 Docetaxel 100 mg BID/75 mg/m2 Cohort 3 CP-868,596 100 mg BID/100 mg/m2 Cohort 3 Docetaxel 100 mg BID/100 mg/m2 Cohort 4b AG-013736 CP-868,596 + AG-013736 + TXT 75 Cohort 4b Docetaxel CP-868,596 + AG-013736 + TXT 75
- Primary Outcome Measures
Name Time Method First-cycle Dose Limiting Toxicities 2.5 years
- Secondary Outcome Measures
Name Time Method Determine the safety and tolerability of the combination of daily CP-868,596 and docetaxel on an every 3-week schedule 2.5 years Determine the safety and tolerability of the combination of daily CP-868,596 plus daily AG-013736 plus docetaxel on an every 3-week schedule 2.5 years To evaluate the pharmacokinetics (PK) of CP-868,596 and docetaxel when given in combination 2.5 years To evaluate the pharmacokinetics (PK) of CP-868,596, AG-013736 and docetaxel when given in combination 2.5 years Conduct biomarker investigations on plasma/serum samples to explore critical events in pharmacodynamic response to CP-868,596 (eg, VEGF, phospho-SHP, etc.) 2.5 years To explore the relationship between polymorphisms in genes involved in the metabolism and transport of CP-868,596 and pharmacokinetic/pharmacodynamic parameters 2.5 years To explore the effects of CP-868,596 on tumor blood flow and permeability via DCE-MRI 2.5 years To assess any preliminary clinical evidence of anti-tumor activity using RECIST 2.5 years
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇦🇺East Melbourne, Victoria, Australia