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

Phase 1

Completed

• Conditions: Solid Tumor Malignancies
• Interventions: Drug: Imetelstat Sodium (GRN163L)

• Registration Number: NCT00310895
• Lead Sponsor: Geron Corporation

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

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-04-04
• Study First Submitted QC: 2006-04-04
• Study First Posted: 2006-04-05
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-22
• Last Update Posted: 2015-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose escalation	Imetelstat Sodium (GRN163L)	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)

Primary Outcome Measures

Name	Time	Method
Safety, DLT, and MTD	Measured during the first cycle of treatment

Secondary Outcome Measures

Name	Time	Method
PK profile and disease response	Within the first 2 cycles of treatment

Trial Locations

Locations (2)

The University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Wayne State University, Karmanos Cancer Center; 🇺🇸 Detroit, Michigan, United States