Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
NCT ID: NCT00729053
Last Updated: 2018-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2004-06-30
2008-11-30
Brief Summary
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* Randomized
* Open-Label Study of single agent IMO-2055
* Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Previous treatment, 0.16mg/kg
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055
immunostimulatory oligonucleotide
Previous treatment, 0.64mg/kg
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055
immunostimulatory oligonucleotide
Treatment Naive, 0.16mg/kg
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
IMO-2055
immunostimulatory oligonucleotide
Treatment Naive, 0.64mg/kg
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
IMO-2055
immunostimulatory oligonucleotide
Interventions
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IMO-2055
immunostimulatory oligonucleotide
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Pre-existing autoimmune or antibody-mediated diseases
* Other significant medical disease.
18 Years
ALL
No
Sponsors
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Idera Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alice Bexon, MD
Role: STUDY_DIRECTOR
Idera Pharmaceuticals
Locations
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Georgetown University, Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Countries
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Other Identifiers
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2055-003
Identifier Type: -
Identifier Source: org_study_id
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