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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00310895

Enrollment

Registered

2006-04-05

Start date

2006-03-31

Completion date

2013-03-31

Last updated

2015-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor Malignancies

Keywords

Refractory, Relapsed

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.

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.

Interventions

DRUGImetelstat Sodium (GRN163L)

Dose increase by 25% if tolerated infused over 2 hours

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety, DLT, and MTD	Measured during the first cycle of treatment

Secondary

Measure	Time frame
PK profile and disease response	Within the first 2 cycles of treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026