Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor Malignancies
NCT ID: NCT00310895
Last Updated: 2015-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
85 participants
INTERVENTIONAL
2006-03-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose escalation
Treatment Schedule 3 will consist of dosing on Days 1, 4, 8, and 11 of each 21 day cycle (3 weeks equals 1 cycle) and Treatment Schedule 4 will consist of dosing on Day 1 of each 28 day cycle (4 weeks equals 1 cycle)
Imetelstat Sodium (GRN163L)
Dose increase by 25% if tolerated infused over 2 hours
Interventions
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Imetelstat Sodium (GRN163L)
Dose increase by 25% if tolerated infused over 2 hours
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Geron Corporation
INDUSTRY
Responsible Party
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Locations
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The University of Chicago Medical Center
Chicago, Illinois, United States
Wayne State University, Karmanos Cancer Center
Detroit, Michigan, United States
Countries
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Related Links
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Related Info
Other Identifiers
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GRN163L CP05-101
Identifier Type: -
Identifier Source: org_study_id