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

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ClinicalTrials.gov Identifier: NCT00729053
Recruitment Status : Completed
First Posted : August 6, 2008
Results First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Idera Pharmaceuticals, Inc.

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)

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: IMO-2055 Phase 2

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 dose group (treatment naive or previously treated) will be randomized to receive one of the 2 doses being studied.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2004
Actual Primary Completion Date : April 2008
Actual Study Completion Date : November 2008


Arm Intervention/treatment
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
Drug: IMO-2055
immunostimulatory oligonucleotide

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
Drug: IMO-2055
immunostimulatory oligonucleotide

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
Drug: IMO-2055
immunostimulatory oligonucleotide

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
Drug: IMO-2055
immunostimulatory oligonucleotide




Primary Outcome Measures :
  1. Best Response by RECIST v1.0 [ Time Frame: From start of treatment every 8 weeks (every 2 cycles), 1 month post-treatment, then every 3 months (up to 1 year) until documented disease progression or initiation of an alternative therapeutic treatment regimen. ]
    Best overall objective (i.e., radiological) response by RECIST v1.0 for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in patients with clear cell metastatic or locally recurrent renal cell carcinoma treated with IMO-2055.


Secondary Outcome Measures :
  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) by National Cancer Institute (NCI) Grade/Severity [ Time Frame: From start of treatment through one month after the end of study visit (up to 28 weeks) ]
    Number of patients with Treatment-emergent adverse events (TEAEs) by National Cancer Institute (NCI) grade/severity that began on or after the date of the first injection of study drug or worsened in severity or frequency after study drug was administered.

  2. Duration of Response by RECIST v1.0 [ Time Frame: Every 8 weeks (2 cycles) from first response to documented disease progression during treatment, 1 month post-treatment, then every 3 months (up to 1 year) until documented disease progression or initiation of an alternative therapeutic treatment regimen. ]
    Time in days from the date of the first response by RECIST v1.0 to documented disease progression or death from any cause.

  3. Overall Survival at 1 Year [ Time Frame: From date of randomization until the date of progression or date of death from any cause, whichever came first, asses up to 1 year after the last dose of study drug. ]
    Overall survival is defined as (date of death +1 - date of randomization). Patients without an event (death) during treatment or follow-up will have their date censored on the last visit the patient was known to be alive.

  4. Time to Disease Progression. [ Time Frame: Every 8 weeks (2 cycles) during the study and every 3 months for 1 year until documented disease progression ]
    Time between the date of randomization to the Study Day of documented disease progression (an increase in tumor burden of at least 20%, appearance of new lesions, or unequivocal progression of non-measurable disease) or death (whichever comes first) by RECIST v1.0. Patients who had not progressed at last disease assessment, but whose progression status was unknown at the date last known alive, date of death, or date of study exit (whichever comes first), had event time censored at the date of last assessment. Patients who did not die and did not progress during treatment or follow-up had their event time censored on the last contact date.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729053


Locations
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United States, District of Columbia
Georgetown University, Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Idera Pharmaceuticals, Inc.
Investigators
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Study Director: Alice Bexon, MD Idera Pharmaceuticals

Additional Information:
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Responsible Party: Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00729053     History of Changes
Other Study ID Numbers: 2055-003
First Posted: August 6, 2008    Key Record Dates
Results First Posted: June 12, 2018
Last Update Posted: June 12, 2018
Last Verified: May 2018
Keywords provided by Idera Pharmaceuticals, Inc.:
renal
cell
renal carcinoma
metastatic
recurrent
treatment naive
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases