NCT03381417

Nanogen Pegcyte Clinical Study for the Prevention of CIN in Breast-cancer Patients.

Completed Phase 3 Last updated 2 January 2018

What this trial tests

Phase 3 trial testing pegcyte in Breast Cancer Female in 128 participants. Completed in 6 November 2017.

Timeline

6 October 2016

Primary endpoint
6 November 2017

6 November 2017

Quick facts

Lead sponsor	Nanogen Pharmaceutical Biotechnology Joint Stock Company
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	128
Start date	6 October 2016
Primary completion	6 November 2017
Estimated completion	6 November 2017
Sites	1 location across Vietnam

Drugs / interventions tested

• pegcyte — full drug profile →
• Neulastim — full drug profile →

Conditions studied

• Breast Cancer Female — all drugs for Breast Cancer Female →

Sponsor

Nanogen Pharmaceutical Biotechnology Joint Stock Company — full company profile →

Who can join

Adults 18 to 65, female only, with Breast Cancer Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Accelerated AC regimen-Doxorubicin 60 mg/m2,Cyclophosphamide 600 mg/m2 on day 1 \& day 14 of each cycle along with G-CSF support for up to 4 cycles, followed by Paclitaxel 175 mg/m2 in the next 4 cycles is the standard clinical practice in Vietnam for breast cancer, this regimen is to facilitate the dose-dense schedule, patients receive every-2-week therapy along with G-CSF support. the accelerated dose-dense schedule improve disease-free and overall survival among women with breast cancer .Primary objective of this study is to compare the efficacy and safety of Nanogen's Pegcyte and Roche's Neulastim for prevention of chemotherapy (Accelerated AC regimen)-induced neutropenia on breast cancer patients. Breast cancer patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will be recruited in this trial. All eligible patients receive single subcutaneous injection of study drugs 24 hours after chemotherapy administration in each cycle for 3 consecutive cycles. Efficacy and safety assessments will be assessed based on the incidence of severe neutropenia in combination of temperature \> 38.3℃ or sepsis or life threatening infection and incidence of serious adverse events.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.