NCT03282825

Clinical Study of Decitabine and Paclitaxel Combination Therapy

An Open-labelled, Parallel, Multiple Ascending Dose, Phase Ib Clinical Study of Decitabine and Paclitaxel Combination Therapy in Treating Patients With Metastatic and Locally Advanced Breast Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Dong Wha Pharmaceutical Co. Ltd. · Industry
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Phase Ib clinical study of Decitabine and Paclitaxel combination therapy

Detailed description

An open-labelled, parallel, multiple ascending dose, phase Ib clinical study of Decitabine and Paclitaxel combination therapy in treating patients with metastatic and locally advanced breast cancer

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Decitabine	The subjects will be sequential administered with Decitabine and paclitaxel 80mg/m2 by IV(intravenous) infusion. Decitabine is starting dose of 15mg/m2 on 1D, 8D, 22D, 28D of a 28day cycle. Paclitaxel 80mg/m2 will be dosed in combination therapy with Decitabine on 8D, 22D, 28D of a 28day cycle.
DRUG	Paclitaxel	The subjects will be sequential administered with Decitabine and paclitaxel 80mg/m2 by IV(intravenous) infusion. Decitabine is starting dose of 15mg/m2 on 1D, 8D, 22D, 28D of a 28day cycle. Paclitaxel 80mg/m2 will be dosed in combination therapy with Decitabine on 8D, 22D, 28D of a 28day cycle.

Timeline

• Start date: 2017-03-28
• Primary completion: 2018-02-01
• Completion: 2018-05-01
• First posted: 2017-09-14
• Last updated: 2018-01-23

Locations

1 site across 1 country: South Korea