Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
This study has been completed.
Sponsor:
Idera Pharmaceuticals, Inc.
Information provided by:
Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00729053
First received: August 1, 2008
Last updated: January 8, 2009
Last verified: January 2009
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Purpose
- Multi-Center
- Randomized
- Open-Label Study of single agent IMO-2055
- Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Cell Carcinoma |
Drug: IMO-2055 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Idera Pharmaceuticals, Inc.:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 224 |
| Study Start Date: | June 2004 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729053
Locations
| United States, District of Columbia | |
| Georgetown University, Lombardi Cancer Center | |
| Washington, District of Columbia, United States, 20007 | |
Sponsors and Collaborators
Idera Pharmaceuticals, Inc.
Investigators
| Study Director: | Alice Bexon, MD | Idera Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Alice Bexon, Idera Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00729053 History of Changes |
| Other Study ID Numbers: | 2055-003 |
| Study First Received: | August 1, 2008 |
| Last Updated: | January 8, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Idera Pharmaceuticals, Inc.:
|
renal cell renal carcinoma |
metastatic recurrent treatment naive |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 16, 2013