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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.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Renal Cell Carcinoma
Intervention: Drug: IMO-2055

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Previous Treatment, 0.16mg/kg   Previous Treatment, 0.64mg/kg   Treatment Naive, 0.16mg/kg   Treatment Naive, 0.64mg/kg
STARTED   23   23   23   23 
COMPLETED   23   23   23   23 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Previous Treatment, 0.16mg/kg   Previous Treatment, 0.64mg/kg   Treatment Naive, 0.16mg/kg   Treatment Naive, 0.64mg/kg   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   21   22   23   89 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 60.1  (10.6)   59.2  (10.3)   65.6  (9.4)   60.6  (12.0)   61.4  (10.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      10  43.5%      2   9.5%      11  50.0%      8  34.8%      31  34.8% 
Male      13  56.5%      19  90.5%      11  50.0%      15  65.2%      58  65.2% 


  Outcome Measures

1.  Primary:   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. ]

2.  Secondary:   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) ]

3.  Secondary:   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. ]

4.  Secondary:   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. ]

5.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Idera Medical Monitor
Organization: Idera Pharmaceuticals, Inc.
phone: 617-679-5500
e-mail: clinicaltrials@iderapharma.com



Responsible Party: Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00729053     History of Changes
Other Study ID Numbers: 2055-003
First Submitted: August 1, 2008
First Posted: August 6, 2008
Results First Submitted: October 10, 2017
Results First Posted: June 12, 2018
Last Update Posted: June 12, 2018