Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer (OPERA)

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)

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.

Study Overview

• Status: Completed
• Conditions: Recurrent or Metastatic Breast Cancer
• Intervention / Treatment: Drug: DHP107; Drug: IV Paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czechia
  • I.P. Pavlova 6
    • Olomouc, I.P. Pavlova 6, Czechia, 775 20
      • Onkologicka klinika, Fakultni nemocnice Olomouc (OUH)
  • K Nemocnici
    • Hořovice, K Nemocnici, Czechia, 1106268 31
      • Onkologicky stacionar, NH Hospital a.s., nemocnice Horovice (NHH)
  • U Nemocnice 499/2
    • Praha 2, U Nemocnice 499/2, Czechia, 128 08
      • Onkologicka klinika, Vseobecna fakultni nemocnice v Praze (VFN)
• United States
  • California
    • Los Angeles, California, United States, 90027
      • California Research Institute (Cri)
    • San Francisco, California, United States, 94115
      • University of California San Francisco (UCSF)
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Regional Hospital (BRRH)
    • Weeki Wachee, Florida, United States, 34607
      • ASCLEPES Research Center(ARC)
  • Kansas
    • Kansas City, Kansas, United States, 64111
      • Saint Luke's Cancer Institute(SLCI)
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center(KUMC)
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Health System Research Institute (AAHS)
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital(MGH)
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Michigan Center of Medical Research(MCMR)
  • Minnesota
    • Minneapolis, Minnesota, United States, 55426
      • Metro-Minnesota Community Oncology Research Consortium (MMCORC)
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Nevada Cancer Research Foundation (NCRF)
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center (UPMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DHP107; The 12 eligible subjects will receive DHP107 and be taken blood samples for PK analysis on Day 1, 8 of cycle 1. Total 48 subjects (including PK subjects) will receive DHP107 200 mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days.	Drug: DHP107; DHP107 200mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days; Other Names: Liporaxel®, Oral Paclitaxel
Experimental: IV paclitaxel; Total 24 subject will receive IV paclitaxel 80 mg/m2 weekly.(3 weeks on/1 week off)	Drug: IV Paclitaxel; IV Paclitaxel 80 mg/m2 QW (3 weeks on/1 week off); Other Names: Taxol Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Daehwa Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Hope Rugo, M.D., University of California, San Francisco; Principal Investigator: David Weng, M.D., Anne Arundel Health System Research Institute (AAHS); Principal Investigator: Neelima Vidula, M.D., Massachusetts General Hospital (MGH); Principal Investigator: Adam Brufsky, M.D., University of Pittsburgh Medical Center (UPMC); Principal Investigator: Timothy Pluard, M.D., Saint Luke's Cancer Institute(SLCI); Principal Investigator: Priyanka Sharma, M.D., University of Kansas Medical Center(KUMC); Principal Investigator: Jane Skelton, M.D., Boca Raton Regional Hospital (BRRH); Principal Investigator: Richard Caradonna, M.D., ASCLEPES Research Center(ARC); Principal Investigator: Yan Ji, M.D., Metro-Minnesota Community Oncology Research Consortium (MMCORC); Principal Investigator: Craig Gordon, D.O., Michigan Center of Medical Research(MCMR); Principal Investigator: Ghassan Aljazayrly, M.D., California Research Institute (Cri); Principal Investigator: John Ellerton, M.D., Nevada Cancer Research Foundation (NCRF); Principal Investigator: Bohuslav Melichar, M.D., Onkologicka klinika, Fakultni nemocnice Olomouc (OUH); Principal Investigator: Martin Smakal, M.D., Onkologicky stacionar, NH Hospital a.s., nemocnice Horovice (NHH); Principal Investigator: Martina Zimovjanova, M.D., Onkologicka klinika, Vseobecna fakultni nemocnice v Praze (VFN)

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2018
• Primary Completion (Actual): December 13, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: October 19, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Breast Cancer; Paclitaxel; Liporaxel; DHP107
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Breast Diseases; Breast Neoplasms; Recurrence; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: 107CS-6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No