San Francisco, California 94115


Purpose:

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.


Criteria:

Inclusion Criteria: 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 Exclusion Criteria: 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).


NCT ID:

NCT03326102


Primary Contact:

Principal Investigator
Hope Rugo, M.D.
University of California, San Francisco

Hope Rugo, M.D.
Phone: 415-353-7070
Email: Hope.Rugo@ucsf.edu


Backup Contact:

N/A


Location Contact:

San Francisco, California 94115
United States

Rugo Hope, M.D.
Phone: 415-353-7070
Email: Hope.Rugo@ucsf.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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