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

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • Subjects who are ≥18 years of age on the date of written informed consent.
  • Subjects with confirmed diagnosis of recurrent or metastatic breast cancer based on histopathology examination
  • Subjects with diagnosis of HER2-negative breast cancer that was confirmed by IHC or in situ hybridization (ISH) assessment of tumor samples
  • Subjects who have received up to 3 lines of therapy for advanced disease, without prior exposure to taxane in the advanced stage setting
  • Subjects who have a life expectancy of ≥12 weeks.
  • Subjects who are able to take oral medication.
  • Subjects who have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Subjects who have measurable disease according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1).
  • Subjects who have adequate organ functions
  • Subjects who are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and procedures.
  • Subjects who have voluntarily agreed to participate by giving written informed consent.
  • Women of childbearing potential who have negative pregnancy test results

Exclusion Criteria

  • Subjects who have history of severe hypersensitive reaction to the active ingredient or any excipients of DHP107 or IV paclitaxel.
  • Subjects who have received prior taxane therapy in the metastatic setting
  • Subjects whose adjuvant or neoadjuvant treatment for early stage breast cancer was completed within 6 months prior to entry into the study.
  • Subjects who received radiation therapy within 2 weeks of randomization (C1D1)
  • Subjects who were diagnosed with New York Heart Association (NYHA) Class II congestive heart failure or have clinically significant arrhythmia not controlled by medication prior to study entry.
  • Subjects who developed cardiovascular disease within 24 weeks prior to study entry, which is deemed to be clinically significant by the Investigator.
  • Subjects with known active hepatitis B or C infection, or hepatobiliary disease, or known history of immunodeficiency virus infection.
  • Subjects with neuropathy grade ≥2 based on CTCAE v4.03 at the time of study entry
  • Subjects with uncontrolled medical or mental illness that, in the Investigator's judgement, could affect treatment tolerability or compliance.
  • Subjects diagnosed with other malignant primary tumor
  • Subjects with symptomatic, untreated metastases to the central nervous system (CNS) at the time of screening.
  • Subjects who are currently receiving prescription or non prescription medications or other products known to be moderate or potent inhibitors/inducers of CYP3A4, P-gp, or CYP2C8.
  • Subjects who cannot tolerate oral administration as determined by the Investigator
  • Pregnant or breastfeeding women.
  • Subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (C1D1).

Locations & Contacts

California

San Francisco
UCSF Medical Center-Mount Zion
Status: Active
Contact: Hope S. Rugo
Phone: 415-353-7070
Email: hope.rugo@ucsf.edu

Kansas

Fairway
University of Kansas Clinical Research Center
Status: Active
Name Not Available
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
University of Kansas Cancer Center-West
Status: Active
Name Not Available
Overland Park
University of Kansas Cancer Center-Overland Park
Status: Active
Name Not Available
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available

Missouri

Kansas City
The University of Kansas Cancer Center-North
Status: Active
Name Not Available
Lee's Summit
The University of Kansas Cancer Center-Lee's Summit
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Daehwa Pharmaceutical Co., Ltd.

Trial IDs

Primary ID 107CS-6
Secondary IDs NCI-2018-01373
Clinicaltrials.gov ID NCT03326102