Carcinoma, Renal Cell Clinical Trial
Official title:
A Phase I/II Study of GTI-2040 and Capecitabine Combination Therapy in Patients With Advanced or Metastatic Renal Cell Carcinoma (mRCC)
| Verified date | January 2008 |
| Source | Aptose Biosciences Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This phase II, 43 patient trial, will evaluate the efficacy of GTI-2040, an antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase (RNR) mRNA, in combination with capecitabine, in the setting of advanced/metastatic renal cell carcinoma. Preclinical studies have shown synergy between GTI-2040 and capecitabine against renal cell carcinoma.
| Status | Completed |
| Enrollment | 43 |
| Est. completion date | |
| Est. primary completion date | December 2004 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
- Age greater than or equal to 18. - Histologically or cytologically confirmed diagnosis of advanced or metastatic renal cell carcinoma for which no effective therapy is available or that is unresponsive to conventional therapy. - Measurable disease. To be considered measurable, a lesion must be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT scan. - Karnofsky performance status of greater than or equal to 70. - Be able to have a central venous like access maintained throughout the study. - Provide written informed consent prior to the initiation of protocol therapy. - Appropriate organ function. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Chicago Medical Center | Chicago | Illinois |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Bay Area Cancer Research Group | Concord | California |
| United States | USC-Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
| United States | Innovative Medical Research of South Florida, Inc. | Miami Shores | Florida |
| United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | SUNY Upstate Medical University | Syracuse | New York |
| United States | CA Hematology Oncology Medical Group | Torrance | California |
| United States | Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Aptose Biosciences Inc. | University of Chicago, Wake Forest University |
United States,
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