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Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma

This study has been completed.
Sponsor:
Information provided by:
Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00729053
First received: August 1, 2008
Last updated: January 8, 2009
Last verified: January 2009
History of Changes

August 1, 2008
January 8, 2009
June 2004
April 2008   (final data collection date for primary outcome measure)
To determine the best overall objective response (Complete Response [CR] + Partial Response [PR]), by RECIST in patients with clear cell metastatic or locally recurrent renal cell carcinoma treated with IMO-2055. [ Time Frame: every 2 cycles ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00729053 on ClinicalTrials.gov Archive Site
  • To determine the safety of IMO-2055 [ Time Frame: all visits ] [ Designated as safety issue: Yes ]
  • To determine the duration of response to IMO-2055 [ Time Frame: every 2 cycles ] [ Designated as safety issue: No ]
  • To determine overall survival [ Time Frame: every 2 cycles ] [ Designated as safety issue: No ]
  • To determine the time to disease progression. [ Time Frame: every 2 cycles ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
A Phase 2, Multi-Center, Randomized, Open-Label Study of Two Dose Levels of IMOxine® (IMO-2055 for Injection) in Patients With Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
  • Multi-Center
  • Randomized
  • Open-Label Study of single agent IMO-2055
  • Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)

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 dose group (treatment naive or previously treated) will be randomized to receive one of the 2 doses being studied.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Cell Carcinoma
Drug: IMO-2055
immunostimulatory oligonucleotide
  • Active Comparator: 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
    Intervention: Drug: IMO-2055
  • Active Comparator: 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
    Intervention: Drug: IMO-2055
  • Active Comparator: 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
    Intervention: Drug: IMO-2055
  • Active Comparator: 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
    Intervention: Drug: IMO-2055
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
224
November 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • Known untreated central nervous system (CNS) metastasis
  • Pre-existing autoimmune or antibody-mediated diseases
  • Other significant medical disease.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00729053
2055-003
No
Dr. Alice Bexon, Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals, Inc.
Not Provided
Study Director: Alice Bexon, MD Idera Pharmaceuticals
Idera Pharmaceuticals, Inc.
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP