A Trial Of SU14813 In Patients With Advanced Solid Malignancies
- Registration Number
- NCT00982267
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to define the Maximum tolerated dose of SU14813 when administered as single agent in patients with solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
Inclusion Criteria
- Patients with a histologically proven advanced solid malignancy for which no recognized therapy was available or for which standard therapy had failed
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Serum albumin ≥3.0 g/dL and adequate haemopoietic, renal and liver function
Exclusion Criteria
- Chemotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy or an investigational agent within 4 weeks before the start of study treatment
- Subjects had to have recovered from all prior treatment toxicities, except alopecia, and from any major surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SU014813 SU014813 -
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose (MTD) 18-Nov-2008
- Secondary Outcome Measures
Name Time Method Plasma pharmacokinetics 18-Nov-2008 Determine the recommended Phase 2 dose (RP2D) 18-Nov-2008 Preliminary information on SU014813 anti-tumor effect; 18-Nov-2008 Plasma targets such as vascular endothelial growth factor (VEGF), soluble VEGF-R2 and soluble KITa 18-Nov-2008
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇳🇱Amsterdam, Netherlands