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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumor Malignancies

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety, DLT, and MTD

Outcome Time Frame:

Measured during the first cycle of treatment

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

GRN163L CP05-101

NCT ID:

NCT00310895

Start Date:

March 2006

Completion Date:

March 2013

Related Keywords:

  • Solid Tumor Malignancies
  • Refractory
  • Relapsed
  • Neoplasms

Name

Location

The University of Chicago Medical CenterChicago, Illinois  60637-1470
Wayne State University, Karmanos Cancer CenterDetroit, Michigan  48201