Status:
COMPLETED
Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor Malignancies
Lead Sponsor:
Geron Corporation
Conditions:
Solid Tumor Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety and the maximum tolerated dose of GRN163L administration in treating patients with refractory or relapsed solid tumor malignancies.
Detailed Description
GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for t...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Male or female
- Measurable or evaluable solid tumor malignancy
- Relapsed, refractory, locally advanced, or metastatic disease
- Disease refractory to or not amenable to standard therapy
- Karnofsky performance status 70-100%
- Life expectancy 3 months or greater
Exclusion
- Pregnant or lactating women
- Primary central nervous system(CNS) malignancy or active CNS metastases
- Hematologic malignancy
- Chemotherapy within 4 weeks prior to study
- Mitomycin C, nitrosoureas within 6 weeks prior to study
- High dose chemotherapy with stem cell support within 6 months prior to study
- Signal transduction inhibitors, monoclonal antibodies, etc. within 4 weeks prior to study
- Systemic hormonal therapy within 4 weeks prior to study
- Anticoagulant therapy, antiplatelet therapy within 2 weeks prior to study
- Radiotherapy within 4 weeks prior to study
- Significant cardiovascular disease
- Serious/active infection
- Major surgical procedures within 2 weeks
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00310895
Start Date
March 1 2006
End Date
March 1 2013
Last Update
December 24 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
2
Wayne State University, Karmanos Cancer Center
Detroit, Michigan, United States, 48201