Safety and Dose Study of GRN163L Administered to 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