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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Geron Corporation
ClinicalTrials.gov Identifier:
NCT00310895
First received: April 4, 2006
Last updated: February 18, 2014
Last verified: February 2014

April 4, 2006
February 18, 2014
March 2006
March 2013   (final data collection date for primary outcome measure)
Safety, DLT, and MTD [ Time Frame: Measured during the first cycle of treatment ] [ Designated as safety issue: Yes ]
  • Safety measured during each dose administration
  • Tolerability of each dose administration
  • Dose-limiting toxicities evaluated at each dose administration
  • Maximum tolerated dose
Complete list of historical versions of study NCT00310895 on ClinicalTrials.gov Archive Site
PK profile and disease response [ Time Frame: Within the first 2 cycles of treatment ] [ Designated as safety issue: No ]
  • Pharmacokinetic profile of GRN163L measured for 2 cycles
  • Preliminary antineoplastic activity
Not Provided
Not Provided
 
Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor Malignancies
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

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumor Malignancies
Drug: Imetelstat Sodium (GRN163L)
Dose increase by 25% if tolerated infused over 2 hours
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)
Intervention: Drug: Imetelstat Sodium (GRN163L)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00310895
GRN163L CP05-101
No
Geron Corporation
Geron Corporation
Not Provided
Not Provided
Geron Corporation
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP