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CPG 7909 in Patients With Stage IV Renal Cell Cancer

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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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