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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/14/2018
Start Date:June 2004
End Date:November 2008

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Trial Summary
Trial Overview
Inclusion Criteria

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)

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.

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.
We found this trial at
1
site
Georgetown University Lombardi Cancer Center
Washington, District of Columbia
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mi
from
Washington,
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