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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00310895
Recruitment Status : Completed
First Posted : April 5, 2006
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
Estimated 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 : March 2006
Primary Completion Date : March 2013
Study Completion Date : March 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


Outcome Measures

Primary Outcome Measures :
  1. Safety, DLT, and MTD [ Time Frame: Measured during the first cycle of treatment ]

Secondary Outcome Measures :
  1. PK profile and disease response [ Time Frame: Within the first 2 cycles of treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310895


Locations
United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Michigan
Wayne State University, Karmanos Cancer Center
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Geron Corporation
More Information

Additional Information:
Responsible Party: Geron Corporation
ClinicalTrials.gov Identifier: NCT00310895     History of Changes
Other Study ID Numbers: GRN163L CP05-101
First Posted: April 5, 2006    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: December 2015

Keywords provided by Geron Corporation:
Refractory
Relapsed

Additional relevant MeSH terms:
Neoplasms