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

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.

Conditions

• Recurrent or Metastatic Breast Cancer

Interventions

DRUG

DHP107

DHP107 200mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days

DRUG

IV Paclitaxel

IV Paclitaxel 80 mg/m2 QW (3 weeks on/1 week off)

Sponsors & Collaborators

• Daehwa Pharmaceutical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Hope Rugo, M.D. · University of California, San Francisco

• David Weng, M.D. · Anne Arundel Health System Research Institute (AAHS)

• Neelima Vidula, M.D. · Massachusetts General Hospital (MGH)

• Adam Brufsky, M.D. · University of Pittsburgh Medical Center (UPMC)

• Timothy Pluard, M.D. · Saint Luke's Cancer Institute(SLCI)

• Priyanka Sharma, M.D. · University of Kansas Medical Center(KUMC)

• Jane Skelton, M.D. · Boca Raton Regional Hospital (BRRH)

• Richard Caradonna, M.D. · ASCLEPES Research Center(ARC)

• Yan Ji, M.D. · Metro-Minnesota Community Oncology Research Consortium (MMCORC)

• Craig Gordon, D.O. · Michigan Center of Medical Research(MCMR)

• Ghassan Aljazayrly, M.D. · California Research Institute (CRI)

• John Ellerton, M.D. · Nevada Cancer Research Foundation (NCRF)

• Bohuslav Melichar, M.D. · Onkologicka klinika, Fakultni nemocnice Olomouc (OUH)

• Martin Smakal, M.D. · Onkologicky stacionar, NH Hospital a.s., nemocnice Horovice (NHH)

• Martina Zimovjanova, M.D. · Onkologicka klinika, Vseobecna fakultni nemocnice v Praze (VFN)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-06

Primary Completion

2022-12-13

Completion

2022-12-13

FDA Drug

Yes

Countries

• United States
• Czechia

Study Locations