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| Sponsor: | Geron Corporation |
|---|---|
| Information provided by (Responsible Party): | Geron Corporation |
| ClinicalTrials.gov Identifier: | NCT01137968 |
Purpose
The purpose of this is to evaluate the efficacy and safety of imetelstat (GRN163L) as maintenance therapy for patients with advanced stage NSCLC who have not progressed after 4 cycles of platinum based therapy.
Participants will be randomized in a 2:1 ratio to imetelstat + standard of care versus standard of care alone. Participants who received bevacizumab with their induction chemotherapy will continue to receive bevacizumab on this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Drug: imetelstat Drug: Bevacizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Study of Imetelstat as Maintenance Therapy After Initial Induction Chemotherapy for Advance Non-small Cell Lung Cancer(NSCLC) |
| Estimated Enrollment: | 96 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: imetelstat plus standard of care
imetelstat plus standard of care (bevacizumab or observation)
|
Drug: imetelstat
9.4 mg/kg over a 2 hour IV infusion on Day 1 and Day 8 of each 21 day cycle until disease progression.
Other Name: GRN163L
Drug: Bevacizumab
Dosage and duration will be according to the FDA-approved bevacizumab package insert. Bevacizumab will be administered on Day 1 of each 21-day cycle.
Other Name: Avastin
|
|
Standard of care
Bevacizumab or observation
|
Drug: Bevacizumab
Dosage and duration will be according to the FDA-approved bevacizumab package insert. Bevacizumab will be administered on Day 1 of each 21-day cycle.
Other Name: Avastin
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow reserve as measured by ANC ≥ 1500/mm3, hemoglobin
≥ 9 g/dL, platelet count ≥ 75,000 μL. Must be measured ≥ 1 week after last transfusion of blood products and/or last dose of hematopoietic growth factor.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from screening and study entry:
Patients will be excluded from being randomized if any of the following criteria apply:
Clinically significant cardiovascular disease or condition including:
Contacts and Locations
Show 33 Study Locations| Study Director: | Martha Blaney, PharmD | Geron Corporation |
| Principal Investigator: | Joan Schiller, MD | University of Texas |
More Information
| Responsible Party: | Geron Corporation |
| ClinicalTrials.gov Identifier: | NCT01137968 History of Changes |
| Other Study ID Numbers: | CP14B012 |
| Study First Received: | June 3, 2010 |
| Last Updated: | May 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
imetelstat imetelstat sodium GRN163L telomerase inhibitor telomerase inhibition maintenance therapy |
non-small cell lung cancer relapsed non-small cell lung cancer advanced non-small cell lung cancer NSCLC, cancer stem cells Bevacizumab post induction chemotherapy |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |