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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

A 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)

Keywords

Recurrent or Metastatic Breast Cancer Breast Cancer DHP107 Paclitaxel Liporaxel Breast Neoplasms Albumin-Bound Paclitaxel

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  1. Subjects who have history of severe hypersensitive reaction to the active ingredient or any excipients of DHP107 or IV paclitaxel.
  2. Subjects who have received prior taxane therapy in the metastatic setting
  3. Subjects whose adjuvant or neoadjuvant treatment for early stage breast cancer was completed within 6 months prior to entry into the study.
  4. Subjects who received radiation therapy within 2 weeks of randomization (C1D1)
  5. 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.
  6. Subjects who developed cardiovascular disease within 24 weeks prior to study entry,which is deemed to be clinically significant by the Investigator.
  7. Subjects with known active hepatitis B or C infection, or hepatobiliary disease, or known history of immunodeficiency virus infection.
  8. Subjects with neuropathy grade ≥2 based on CTCAE v4.03 at the time of study entry
  9. Subjects with uncontrolled medical or mental illness that, in the Investigator's judgement, could affect treatment tolerability or compliance.
  10. . Subjects diagnosed with other malignant primary tumor
  11. . Subjects with symptomatic, untreated metastases to the central nervous system (CNS) at the time of screening.
  12. . 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.
  13. . Subjects who cannot tolerate oral administration as determined by the Investigator
  14. . Pregnant or breastfeeding women.
  15. . Subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (C1D1).

Locations

  • UCSF School of Medicine not yet accepting patients
    San Francisco, California, 94115, United States
  • University of Kansas Cancer Center(KUCC) not yet accepting patients
    Kansas City, Kansas, 66160, United States
  • Saint Luke's Cancer Institute(SLCI) not yet accepting patients
    Kansas City, Kansas, 64111, United States
  • MD anderson cancer center not yet accepting patients
    Houston, Texas, 77030, United States
  • Massachusetts General Hospital(MGH) not yet accepting patients
    Boston, Massachusetts, 02114, United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Daehwa Pharmaceutical Co., Ltd.
ID
NCT03326102
Phase
Phase 2
Lead Scientist
Hope Rugo
Study Type
Interventional
Last Updated
October 25, 2017
I’m interested in this study!