CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Guadecitabine +1 moredrug
Likely dose
Guadecitabine 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/NCT03913455
NCT03913455Phase 2Completed
CompareCT.gov

A Phase II Study Evaluating Efficacy and Safety of Hypomethylating Agent Guadecitabine in Combination With Carboplatin in Extensive Stage Small Cell Lung Cancer

Shadia Jalal, MD·interventional·Posted Apr 12, 2019·Updated Dec 20, 2023

In Brief

A Phase 2 clinical trial evaluating Guadecitabine and Carboplatin for Small Cell Lung Cancer and Extensive-stage Small Cell Lung Cancer. Completed, enrolled 24 participants across 4 sites.

Detailed Summary

This is a phase II, open-label, single arm, single-stage study. Both, chemo-sensitive and chemo-resistant patients will be enrolled and treated with 4 cycles of combination of Guadecitabine and carboplatin

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Cancer, Extensive-stage Small Cell Lung Cancer
CountriesUnited States
CollaboratorsAstex Pharmaceuticals, Inc., Indiana University

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 12, 2019
Enrollment StartJun 6, 2019
Primary CompletionApr 14, 2021
Study CompletionFeb 2, 2022
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.2 years ago

Interventions

Guadecitabinedrug

Guadecitabine 30 mg/m2 subcutaneously Days 1-5

Carboplatindrug

Carboplatin AUC 4 IV Day 5