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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 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.

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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.

Conditions Studied

Extensive-stage Small-cell Lung Cancer

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

FieldValue
Enrollment Target 81 participants
Start Date 2009-12
Est. Completion 2015-03
Phase Phase 2

Sponsor

SCRI Development Innovations

146 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01076504

The ClinicalTrials.gov registry entry for NCT01076504 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 172-participant average among 25 other Extensive-stage Small-cell Lung Cancer trials with a reported enrollment target (53% lower). The listed sponsor is SCRI Development Innovations, which has 146 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.