Neoplasms, Solid Tumors
Conditions
Keywords
cancer
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.
Interventions
DRUGSU014813
Escalating doses of SU014813 from 50 to 250mg/day . Capsules administered daily either as continuous dosing or in cycles of 4 weeks on 1 week off
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose (MTD) | 18-Nov-2008 |
Secondary
| Measure | Time frame |
|---|---|
| Determine the recommended Phase 2 dose (RP2D) | 18-Nov-2008 |
| Preliminary information on SU014813 anti-tumor effect; | 18-Nov-2008 |
| Plasma pharmacokinetics | 18-Nov-2008 |
| Plasma targets such as vascular endothelial growth factor (VEGF), soluble VEGF-R2 and soluble KITa | 18-Nov-2008 |
Countries
Germany, Netherlands
Outcome results
None listed