CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 135 enrolled
Drug / intervention
Aldoxorubicin +1 moredrug
Likely dose
Aldoxorubicin 230 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/NCT02200757
NCT02200757Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer Who Either Relapsed or Were Refractory to Prior Chemotherapy

ImmunityBio, Inc.·interventional·Posted Jul 25, 2014·Updated Jun 25, 2024

In Brief

A Phase 2 clinical trial evaluating Aldoxorubicin and Topotecan for Metastatic Small Cell Lung Cancer. Completed, enrolled 135 participants across 29 sites in 3 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of aldoxorubicin compared to topotecan in subjects with metastatic small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Small Cell Lung Cancer
CountriesHungary, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 25, 2014
Enrollment StartApr 20, 2015
Primary CompletionMay 15, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.9 years ago

Interventions

Aldoxorubicindrug

230 mg/m2 (170 mg/m2 doxorubicin equivalent) intravenously on Day 1 of each 21-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs.

Topotecandrug

1.5 mg/m2/day intravenously for 5 consecutive days on Day 1 of each 21-day cycle OR 4 mg/m2 intravenously on Days 1, 8 and 15 of each 28-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs