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NCT01076504 · ClinicalTrials.gov registry record · Phase 2
A Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer
A Phase 2 study of Extensive-stage Small-cell Lung Cancer, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
- 20
- Study locations
NCT01076504: Completed Phase 2 study of Extensive-stage Small-cell Lung Cancer, sponsored by SCRI Development Innovations.
NCT01076504 is a Phase 2 study of Extensive-stage Small-cell Lung Cancer that has completed, run by SCRI Development Innovations. The registered enrollment target is 81 participants, below the 172-participant average among 25 other Extensive-stage Small-cell Lung Cancer trials with a reported enrollment target (53% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01076504, a Phase 2 study of Extensive-stage Small-cell Lung Cancer, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
- 20
- Study locations
Study Summary
This proposed trial will investigate the combination of amrubicin and carboplatin in the first-line treatment of patients with extensive-stage small cell lung cancer (ES- SCLC). Since myelosuppression is the most common toxicity produced by this drug combination, pegfilgrastim will be administered with each treatment cycle. This trial will be the first clinical trial to evaluate a combination of amrubicin and carboplatin in the first-line treatment of ES SCLC in a U.S. population.
Primary Outcome
Percentage of patients still alive one year after their first treatment
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Amrubicin
- DRUG Pegfilgrastim
Study Locations (20)
Florida
- Florida Cancer Specialists - Fort Myers
- Watson Clinic Center for Cancer Care and Research - Lakeland
- Florida Hospital Cancer Institute - Orlando
Tennessee
- Chattanooga Oncology Hematology Associates - Chattanooga
- Family Cancer Center - Collierville
- Tennessee Oncology, PLLC - Nashville
Kentucky
- Baptist Hospital East - Louisville
- Norton Cancer Institute - Louisville
Maryland
- Center for Cancer and Blood Disorders - Bethesda
- National Capital Clinical Research Consortium - Bethesda
Virginia
- Peninsula Cancer Institute - Newport News
- Virginia Cancer Institute - Richmond
Arkansas
- Northeast Arkansas Clinic - Jonesboro
Georgia
- Medical Oncology Associates of Augusta - Augusta
Louisiana
- Hematology Oncology Clinic, LLP - Baton Rouge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2009-12 |
| Est. Completion | 2015-03 |
| Phase | Phase 2 |
What the finished NCT01076504 record still lists
NCT01076504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 172-participant average among 25 other Extensive-stage Small-cell Lung Cancer trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Extensive-stage Small-cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Carboplatin is the first listed.
NCT01076504 names 20 study sites across 13 states, led by Florida, Tennessee, Kentucky.
Frequently Asked Questions
What is clinical trial NCT01076504 about?
NCT01076504 is a clinical study titled "A Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer". This proposed trial will investigate the combination of amrubicin and carboplatin in the first-line treatment of patients with extensive-stage small cell lung cancer (ES- SCLC). Since myelosuppression is the most common toxicity produced by this drug combination, pegfilgrastim will be administered w...
What is the current status of trial NCT01076504?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2009-12. Estimated completion is 2015-03.
What conditions does trial NCT01076504 study?
This clinical trial studies the following conditions: Extensive-stage Small-cell Lung Cancer.
What interventions are being tested in trial NCT01076504?
The interventions under investigation include: Carboplatin (DRUG), Amrubicin (DRUG), Pegfilgrastim (DRUG).
Who is sponsoring clinical trial NCT01076504?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01076504 being conducted?
This trial has 20 study locations across Arkansas, Florida, Georgia, Kentucky, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Extensive-stage Small-cell Lung Cancer
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Where NCT01076504's enrollment target sits among peer trials
81 15th of 25 higher than 11 of 25 other Extensive-stage Small-cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Extensive-stage Small-cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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