Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All Drugs and Chemicals

Imetelstat

Motesanib diphosphate

Enzyme Inhibitors

Protein Kinase Inhibitors

25% dose escalation infused over 2 hours weekly

Imetelstat Sodium (GRN163L)

Steve Kelsey, MD

The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered to patients with refractory or relapsed multiple myeloma.

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.

Safety and Dose Study of GRN163L Administered to Treat Patients With Refractory or Relapsed Multiple Myeloma

A Phase 1 Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of GRN163L in Patients With Refractory or Relapsed Multiple Myeloma

Geron Corporation

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Patients will be enrolled in the order of confirmation of eligibility. Dose cohorts will be filled sequentially with a minimum of 3 patients. Once assigned to a dose cohort, each patient will continue to be treated at the same dose level throughout the course of the study.

The starting dose of GRN163L for this study will be 3.2 mg/kg. Subsequent dose levels will be 4.8, 6, 7.5, 9, 11, and 13.5 mg/kg. The maximum dose to be administered will not exceed 13.5 mg/kg.

Paclitaxel and carboplatin will be administered on Day 2 of each 21-day cycle.

The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered in combination with a standard paclitaxel/carboplatin regimen to patients with advanced or metastatic non-small cell lung cancer.

Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer

A Phase I Study of GRN163L in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Bortezomib

Dexamethasone acetate

Stephen Kelsey, MD

The purpose of this study is to determine safety and the maximum tolerated dose (MTD) of GRN163L and Velcade with and without Decadron when administered to patients with refractory or relapsed multiple myeloma.

Safety and Dose Study of GRN163L and Velcade to Treat Patients With Refractory or Relapsed Myeloma

A Phase I Study of GRN163L in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Dose Study of GRN163L Administered to Treat Patients With Refractory or Relapsed Multiple Myeloma	NCT00594126	Multiple Myelom...	Imetelstat Sodi...	18 Years -	Geron Corporation
Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer	NCT00510445	Lung Cancer	Imetelstat Sodi...	18 Years -	Geron Corporation
Safety and Dose Study of GRN163L and Velcade to Treat Patients With Refractory or Relapsed Myeloma	NCT00718601	Multiple Myelom...	Imetelstat Sodi...	18 Years -	Geron Corporation
Safety and Dose Study of GRN163L and Velcade to Treat Patients With Refractory or Relapsed Myeloma	NCT00718601	Multiple Myelom...	Imetelstat Sodi...	18 Years -	Geron Corporation

Spots Global Cancer Trial Database for imetelstat sodium (grn163l)