Carcinoma, Renal Cell
Conditions
Brief summary
This study will determine the highest tolerable dose of CP-675,206 when given in combination with SU011248.
Interventions
DRUGCP-675,206
CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.
DRUGSU011248
SU011248 administered at a dose of 37.5mg/day every day.
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven renal cell carcinoma with metastases * Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
Exclusion criteria
* Prior treatment with more than one systemic therapy for metastatic renal cell carcinoma * History of or known brain metastases, spinal cord compression or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening Computed Axial Tomography (CT) or Magnetic Resonance Imaging (MRI) scan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the highest tolerable dose of CP-675,206 that can be combined with SU011248. The safety observation period will be 6 weeks from the first dose of study drug | 6 weeks after first dose |
Secondary
| Measure | Time frame |
|---|---|
| To allow for the possibility of genotyping should an unexpected outcome or an increase in unexplained adverse events be reported | 18 months |
| To evaluate the pharmacokinetics (PK) of CP-675,206 and SU011248 when given in combination | up to 18 months |
| To monitor for an antibody response to CP-675,206 | up to 18 months |
| To assess any preliminary evidence of anti-tumor activity: 6-18 months after last subject enrolled | 6-18 months after last subject enrolled |
Countries
United States
Outcome results
None listed