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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00043407 |
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Date of registration:
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08/08/2002 |
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Primary sponsor: |
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Public title:
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CPG 7909 in Patients Wih Stage IV Renal Cell Cancer
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Scientific title:
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A Phase I/II, Open Label, Multi-Center Study For The Evaluation Of CPG 7909 In Patients With Stage Iv Renal Cell Carcinoma |
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Date of first enrolment:
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March 2002 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00043407 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Stage IV Renal Cell Carcinoma with lung and/or soft tissue metastasis Nephrectomy
Measurable disease by RECIST criteria
Exclusion Criteria:
CNS, bone or Liver metastasis Tumors that are mainly papillary, chromophobe, medullary,
collecting duct, or unclassified Prior immunotherapy, including IL-2 or IFN-alpha
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Carcinoma, Renal Cell
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Intervention(s)
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Drug: CPG 7909
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Primary Outcome(s)
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To determine the tolerability of escalating doses of subcutaneously administered CPG 7909 Injection up to a maximum dose of 0.81 mg/kg in patients with metastatic renal cell cancer.
[Time Frame: Indeterminate]
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To establish the maximum tolerated dose for CPG 7909 Injection as monotherapy in patients with metastatic renal cell cancer up to a dose of 0.81mg/kg.
[Time Frame: Indeterminate]
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To estimate the overall tumor response rate of CpG 7909 according to the RECIST criteria in patients with metastatic renal cell cancer.
[Time Frame: Indeterminate]
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Secondary Outcome(s)
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To assess tolerability relative to dose exposure, immunologic activity, the pharmacokinetic and pharmacodynamic profile of CPG 7909 Injection, time to progression, duration of response, and time to survival.
[Time Frame: Indeterminate]
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Secondary ID(s)
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C010
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CO10, A8501022
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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