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

Solid Tumor Malignancies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310895
• Other study ID #: GRN163L CP05-101
• Status: Completed
• Phase: Phase 1
• First received: April 4, 2006
• Last updated: December 22, 2015
• Start date: March 2006
• Est. completion date: March 2013

Study information

• Verified date: December 2015
• Source: Geron Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor Malignancies

Intervention

Drug:
• Imetelstat Sodium (GRN163L)
Dose increase by 25% if tolerated infused over 2 hours

Locations

Country	Name	City	State
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	Wayne State University, Karmanos Cancer Center	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Geron Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, DLT, and MTD		Measured during the first cycle of treatment	Yes
Secondary	PK profile and disease response		Within the first 2 cycles of treatment	No

External Links

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