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

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729053
• Other study ID #: 2055-003
• Status: Completed
• Phase: Phase 2
• Start date: June 2004
• Est. completion date: November 2008

Study information

• Verified date: May 2018
• Source: Idera Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• Multi-Center

• Randomized

• Open-Label Study of single agent IMO-2055

• Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Cell Carcinoma

Intervention

Drug:
• IMO-2055
immunostimulatory oligonucleotide

Locations

Country	Name	City	State
United States	Georgetown University, Lombardi Cancer Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Idera Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Response by RECIST v1.0	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	Number of Participants With Treatment-emergent Adverse Events (TEAEs) by National Cancer Institute (NCI) Grade/Severity	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)
Secondary	Duration of Response by RECIST v1.0	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.
Secondary	Overall Survival at 1 Year	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.
Secondary	Time to 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.	Every 8 weeks (2 cycles) during the study and every 3 months for 1 year until documented disease progression

External Links

•   Sponsor Website