Study:
Phase I/II Open Label Multi-Center Study of CPG 7909 in Patients With Stage IV Renal Cell Cancer
Rationale:
n/a
Purpose:
In the Phase I portion of the trial, escalating doses CPG 7909 injection will be administered
subcutaneously up to a maximum dose of 0.81 mg/kg in patients with metastatic renal cell
cancer. The maximum tolerated dose for CPG 7909 injection as monotherapy will be determined.
In the phase II portion of the trial, the overall tumor response rate of CPG 7909 will be
estimated according to the RECIST criteria in patients with metastatic renal cell cancer.
Tolerability will be assessed according to dose exposure, immunologic activity, the
pharmacokinetic and pharmacodynamic profile of CPG 7909 injection, time to progression,
duration of response, and time to survival.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Renal Cell Cancer Post Nephrectomy |
Drug: CPG 7909 |
Phase 1/Phase 2 |
Verified by
Pfizer
October, 2008
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov identifier: NCT00043407
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Cleveland Clinic Cancer Center
Cleveland, Ohio 44195
United States
n/a