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

December 22, 2015 updated by: Geron Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

85

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University, Karmanos Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety, DLT, and MTD
Time Frame: Measured during the first cycle of treatment
Measured during the first cycle of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
PK profile and disease response
Time Frame: Within the first 2 cycles of treatment
Within the first 2 cycles of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geron Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

April 4, 2006

First Submitted That Met QC Criteria

April 4, 2006

First Posted (ESTIMATE)

April 5, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2015

Last Update Submitted That Met QC Criteria

December 22, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRN163L CP05-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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