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

Geron

Status and phase: Completed; Phase 1

Conditions: Solid Tumor Malignancies

Treatments: Drug: Imetelstat Sodium (GRN163L)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00310895

GRN163L CP05-101

Details and patient eligibility

About

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.

Full 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 the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.

Enrollment: 85 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

Dose escalation

Experimental group

Description:

Treatment Schedule 3 will consist of dosing on Days 1, 4, 8, and 11 of each 21 day cycle (3 weeks equals 1 cycle) and Treatment Schedule 4 will consist of dosing on Day 1 of each 28 day cycle (4 weeks equals 1 cycle)

Treatment:

Drug: Imetelstat Sodium (GRN163L)