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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Geron Corporation
• Treatments: Imetelstat; Motesanib diphosphate; Niacinamide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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