Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer
This study has been completed.
Sponsor:
Geron Corporation
Information provided by (Responsible Party):
Geron Corporation
ClinicalTrials.gov Identifier:
NCT00510445
First received: July 31, 2007
Last updated: January 24, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: Imetelstat Sodium (GRN163L) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of GRN163L in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Geron Corporation:
Primary Outcome Measures:
- Safety and MTD [ Time Frame: First 3 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- PK and efficacy [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 27 |
| Study Start Date: | July 2007 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Single Arm Trial
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.
|
Drug: Imetelstat Sodium (GRN163L)
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. |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of NSCLC
- Stage IIIb with pleural effusion, Stage IV, or recurrent disease
- Measurable or evaluable disease by RECIST criteria
- ECOG performance status 0-1
- Adequate hepatic/renal function and platelet count
- If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction > 50%
Exclusion Criteria:
- More than 2 prior chemotherapy regimens for metastatic disease (prior adjuvant chemotherapy is allowed)
- Tumor progression during treatment with paclitaxel (refractory to paclitaxel)
- Taxane-based regimen within 12 weeks
- Any systemic therapy for cancer within 4 weeks
- Anti-platelet therapy within 2 weeks, other than low dose aspirin prophylaxis therapy
- Therapeutic anticoagulation therapy except for low dose warfarin (eg, 1 mg by mouth per day)
- Radiation therapy within 3 weeks
- Major surgery within 4 weeks (central line placement is allowed)
- Prolongation of PT or aPTT > the ULN or fibrinogen < the LLN
- History of or active central nervous system metastatic disease
- Any other active malignancy
- Active or chronically recurrent bleeding (eg, active peptic ulcer disease)
- Clinically significant infection
- Active autoimmune disease requiring immunosuppressive therapy
- Clinically significant cardiovascular disease or condition
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510445
Locations
| United States, Maryland | |
| University of Maryland Greenebaum Cancer Center | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Texas | |
| The University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Wisconsin | |
| University of Wisconsin, Paul P. Carbone Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792 | |
Sponsors and Collaborators
Geron Corporation
More Information
Additional Information:
No publications provided
| Responsible Party: | Geron Corporation |
| ClinicalTrials.gov Identifier: | NCT00510445 History of Changes |
| Other Study ID Numbers: | GRN163L CP14A005 |
| Study First Received: | July 31, 2007 |
| Last Updated: | January 24, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Geron Corporation:
|
Non Small Cell Lung Cancer Advanced Non Small Cell Lung Cancer Metastatic Non Small Cell Lung Cancer |
Additional relevant MeSH terms:
|
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 |
Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 22, 2013