Combination of Capecitabine and GTI-2040 in the Treatment of Renal Cell Carcinoma

Aptose Biosciences

Status and phase

Completed

Phase 2

Phase 1

Conditions

Carcinoma, Renal Cell

Metastases, Neoplasm

Treatments

Drug: GTI-2040

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00056173

L01-1409

Details and patient eligibility

About

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.

Enrollment

43 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.