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

Sponsor

Geron Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00310895

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

42.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor Malignancies	Drug: Imetelstat Sodium (GRN163L)	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

85 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and MTD of GRN163L in Patients With Refractory or Relapsed Solid Tumor Malignancies

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose escalation 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)	Drug: Imetelstat Sodium (GRN163L) Dose increase by 25% if tolerated infused over 2 hours

Arm

Intervention/Treatment

Experimental: Dose escalation

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)

Drug: Imetelstat Sodium (GRN163L)

Dose increase by 25% if tolerated infused over 2 hours

Outcome Measures

Primary Outcome Measures

Safety, DLT, and MTD [Measured during the first cycle of treatment]

Secondary Outcome Measures

PK profile and disease response [Within the first 2 cycles of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Chicago Medical Center	Chicago	Illinois	United States	60637
2	Wayne State University, Karmanos Cancer Center	Detroit	Michigan	United States	48201