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Completed

NCT Number: NCT00310895

Safety and Dose Study of GRN163L Administered to 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.

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Key information

Conditions

Solid Tumor Malignancies Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The University of Chicago Medical Center, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imetelstat Sodium (GRN163L)

Drug

Dose increase by 25% if tolerated infused over 2 hours

Primary outcomes

  1. Safety, DLT, and MTD

    Time frame: Measured during the first cycle of treatment

Secondary outcomes

  1. PK profile and disease response

    Time frame: Within the first 2 cycles of treatment

Sponsors and collaborators

Lead sponsor

Geron Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Apr 5, 2006
Registry last updated
Dec 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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