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
  Purpose

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 Intervention Phase
Solid Tumor Malignancies
Drug: Imetelstat Sodium (GRN163L)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Geron Corporation:

Primary Outcome Measures:
  • Safety, DLT, and MTD [ Time Frame: Measured during the first cycle of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK profile and disease response [ Time Frame: Within the first 2 cycles of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 85
Study Start Date: March 2006
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Geron Corporation
ClinicalTrials.gov Identifier: NCT00310895     History of Changes
Other Study ID Numbers: GRN163L CP05-101
Study First Received: April 4, 2006
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Geron Corporation:
Refractory
Relapsed

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 01, 2014