Status:
COMPLETED
Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
Lead Sponsor:
Idera Pharmaceuticals, Inc.
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
* Multi-Center * Randomized * Open-Label Study of single agent IMO-2055 * Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)
Detailed Description
This is a study of 2 dose levels (0.16 or 0.64 mg/kg) of IMO-2055 administered by weekly subcutaneous (SC) injections in two patient populations, treatment naïve or previously treated patients. Each d...
Eligibility Criteria
Inclusion
- Histologically confirmed stage IV clear cell renal carcinoma with metastatic or locally recurrent disease that is not surgically resectable.
- At least one measurable lesion
- Adequate organ function
- Any prior treatment of renal cell cancer was concluded at least 4 weeks prior.
- If female and of childbearing potential, a negative serum pregnancy test performed and documented no more than 14 days before the first dose of study drug.
Exclusion
- Known untreated central nervous system (CNS) metastasis
- Pre-existing autoimmune or antibody-mediated diseases
- Other significant medical disease.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00729053
Start Date
June 1 2004
End Date
November 1 2008
Last Update
June 12 2018
Active Locations (1)
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1
Georgetown University, Lombardi Cancer Center
Washington D.C., District of Columbia, United States, 20007