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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Renal Cell Carcinoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

every 2 cycles

Safety Issue:

No

Principal Investigator

Alice Bexon, MD

Investigator Role:

Study Director

Investigator Affiliation:

Idera Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

2055-003

NCT ID:

NCT00729053

Start Date:

June 2004

Completion Date:

November 2008

Related Keywords:

  • Renal Cell Carcinoma
  • renal
  • cell
  • renal carcinoma
  • metastatic
  • recurrent
  • treatment naive
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Georgetown University, Lombardi Cancer CenterWashington, District of Columbia  20007