Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer

Recurrent or Metastatic Breast Cancer Clinical Trial

— OPERA  

Official title:

A Multi-national,Multi-center, Open-label, Phase 2 Clinical Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of DHP107 (Liporaxel®,Oral Paclitaxel) Compared to IV Paclitaxel in Patients With Recurrent or Metastatic Breast Cancer(OPERA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326102
• Other study ID #: 107CS-6
• Status: Completed
• Phase: Phase 2
• Start date: July 6, 2018
• Est. completion date: December 13, 2022

Study information

• Verified date: January 2022
• Source: Daehwa Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of DHP107 (Oral Paclitaxel, Korea brand name: Liporaxel®) compared to IV Paclitaxel in patients with Recurrent or Metastatic Breast Cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 13, 2022
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Subjects with confirmed diagnosis of recurrent or metastatic breast cancer based on histopathology examination

2. Subjects with diagnosis of HER2-negative breast cancer that was confirmed by IHC or in situ hybridization (ISH) assessment of tumor samples

3. Subjects who have received up to 3 lines of therapy for advanced disease, without prior exposure to taxane in the advanced stage setting

4. Subjects who have a performance status of =2 on the Eastern Cooperative Oncology Group (ECOG) scale.

5. Subjects who have measurable disease according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1).

Key Exclusion Criteria:

1. Subjects who have received prior taxane therapy in the metastatic setting

2. Subjects whose adjuvant or neoadjuvant treatment for early stage breast cancer was completed within 6 months prior to entry into the study.

3. Subjects with neuropathy grade =2 based on CTCAE v4.03 at the time of study entry

4. Subjects with symptomatic, untreated metastases to the central nervous system (CNS) at the time of screening.

5. Subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (C1D1).

Related Conditions & MeSH terms

• Breast Neoplasms
• Recurrence
• Recurrent or Metastatic Breast Cancer

Intervention

Drug:
• DHP107
DHP107 200mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days
• IV Paclitaxel
IV Paclitaxel 80 mg/m2 QW (3 weeks on/1 week off)

Locations

Country	Name	City	State
Czechia	Onkologicky stacionar, NH Hospital a.s., nemocnice Horovice (NHH)	Horovice	K Nemocnici
Czechia	Onkologicka klinika, Fakultni nemocnice Olomouc (OUH)	Olomouc	I.P. Pavlova 6
Czechia	Onkologicka klinika, Vseobecna fakultni nemocnice v Praze (VFN)	Praha 2	U Nemocnice 499/2
United States	Anne Arundel Health System Research Institute (AAHS)	Annapolis	Maryland
United States	Boca Raton Regional Hospital (BRRH)	Boca Raton	Florida
United States	Massachusetts General Hospital(MGH)	Boston	Massachusetts
United States	Michigan Center of Medical Research(MCMR)	Farmington Hills	Michigan
United States	Saint Luke's Cancer Institute(SLCI)	Kansas City	Kansas
United States	University of Kansas Medical Center(KUMC)	Kansas City	Kansas
United States	Nevada Cancer Research Foundation (NCRF)	Las Vegas	Nevada
United States	California Research Institute (CRI)	Los Angeles	California
United States	Metro-Minnesota Community Oncology Research Consortium (MMCORC)	Minneapolis	Minnesota
United States	University of Pittsburgh Medical Center (UPMC)	Pittsburgh	Pennsylvania
United States	University of California San Francisco (UCSF)	San Francisco	California
United States	ASCLEPES Research Center(ARC)	Weeki Wachee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Daehwa Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

United States,  Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate(ORR)	ORR is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria	Every 8 weeks upto 18 months from randomization date
Secondary	Progression free survival(PFS)	PFS is defined as the time from date of randomization until the date of first documented progression or death.	Up to 18 months from randomization date
Secondary	Overall survival(OS)	OS is defined as the time from the date of inclusion to the date of death.	Up to 36 months from FPI
Secondary	Time to treatment failure(TTF)	TTF is defined as the time from the randomization date to the date of discontinuation of treatment, regardless of the cause.	Up to 18 months from randomization date
Secondary	Duration of response(DOR)	DOR is the time between the initial response to therapy and subsequent disease progression or relapse.	Up to 18 months from randomization date
Secondary	Disease control rate(DCR)	DCR is defined as the percentage of subjects who were evaluated for complete response(CR), partial response(PR), and stable disease(SD) as the best response among from randomization.	Up to 18 months from randomization date
Secondary	Quality of life(QoL)	Evaluate changes compared to baseline using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	after randomization(C1D1), D1 of every 3rd cycle(each cycle consists of 28 days) up to 18 months
Secondary	PK	Pharmacokinetics is defined as the study of the time course of drug absorption, distribution, metabolism, and excretion.	The 12 eligible subjects will receive DHP107 and be taken blood samples for PK analysis on Day 1, 8 of Cycle 1