Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor Malignancies

Completed · Phase 1

Conditions studied: Solid Tumor Malignancies

In brief

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.

Key facts

Study ID

NCT00310895

Run by

Geron Corporation

People needed

85

Starts

2006-03-01

Expected to finish

2013-03-01

Last updated by the study team

2015-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Chicago Medical Center — Chicago, Illinois, United States
• Wayne State University, Karmanos Cancer Center — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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