- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00729053
Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
May 14, 2018 updated by: Idera Pharmaceuticals, Inc.
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)
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown University, Lombardi Cancer Center
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
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
|
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
|
immunostimulatory oligonucleotide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From start of treatment through one month after the end of study visit (up to 28 weeks)
|
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.
|
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.
|
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.
|
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.
|
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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Every 8 weeks (2 cycles) during the study and every 3 months for 1 year until documented disease progression
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
August 1, 2008
First Submitted That Met QC Criteria
August 5, 2008
First Posted (Estimate)
August 6, 2008
Study Record Updates
Last Update Posted (Actual)
June 12, 2018
Last Update Submitted That Met QC Criteria
May 14, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2055-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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