NCT03913455

Guadecitabine in Combination With Carboplatin in Extensive Stage Small Cell Lung Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Shadia Jalal, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Small Cell Lung Cancer
• Extensive-stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Guadecitabine	Guadecitabine 30 mg/m2 subcutaneously Days 1-5
DRUG	Carboplatin	Carboplatin AUC 4 IV Day 5

Timeline

• Start date: 2019-06-06
• Primary completion: 2021-04-14
• Completion: 2022-02-02
• First posted: 2019-04-12
• Last updated: 2023-12-20
• Results posted: 2023-12-20

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study