CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 81 enrolled
Drug / intervention
Amrubicin +2 moredrug
Likely dose
Amrubicin 30 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01076504
NCT01076504Phase 2Completed
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A Phase II Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer

SCRI Development Innovations, LLC·interventional·Posted Feb 26, 2010·Updated May 5, 2016

In Brief

A Phase 2 clinical trial evaluating Amrubicin, Carboplatin, and 1 other intervention for Extensive-Stage Small Cell Lung Cancer. Completed, enrolled 81 participants across 20 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExtensive-Stage Small Cell Lung Cancer
CountriesUnited States
CollaboratorsCelgene

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 26, 2010
Enrollment StartDec 1, 2009
Primary CompletionMar 1, 2012
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.3 years ago

Interventions

Amrubicindrug

30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle

Carboplatindrug

AUC=5 IV, Day 1 of each 3-week treatment cycle

Pegfilgrastimdrug

6 mg SQ on Day 4 of each 3 week treatment cycle