Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer
NCT ID: NCT03326102
Last Updated: 2024-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2018-07-06
2022-12-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
DHP107
DHP107 200mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days
IV paclitaxel
Total 24 subject will receive IV paclitaxel 80 mg/m2 weekly.(3 weeks on/1 week off)
IV Paclitaxel
IV Paclitaxel 80 mg/m2 QW (3 weeks on/1 week off)
Interventions
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DHP107
DHP107 200mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days
IV Paclitaxel
IV Paclitaxel 80 mg/m2 QW (3 weeks on/1 week off)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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).
Exclusion Criteria
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).
18 Years
ALL
No
Sponsors
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Daehwa Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hope Rugo, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
David Weng, M.D.
Role: PRINCIPAL_INVESTIGATOR
Anne Arundel Health System Research Institute (AAHS)
Neelima Vidula, M.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital (MGH)
Adam Brufsky, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center (UPMC)
Timothy Pluard, M.D.
Role: PRINCIPAL_INVESTIGATOR
Saint Luke's Cancer Institute(SLCI)
Priyanka Sharma, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center(KUMC)
Jane Skelton, M.D.
Role: PRINCIPAL_INVESTIGATOR
Boca Raton Regional Hospital (BRRH)
Richard Caradonna, M.D.
Role: PRINCIPAL_INVESTIGATOR
ASCLEPES Research Center(ARC)
Yan Ji, M.D.
Role: PRINCIPAL_INVESTIGATOR
Metro-Minnesota Community Oncology Research Consortium (MMCORC)
Craig Gordon, D.O.
Role: PRINCIPAL_INVESTIGATOR
Michigan Center of Medical Research(MCMR)
Ghassan Aljazayrly, M.D.
Role: PRINCIPAL_INVESTIGATOR
California Research Institute (CRI)
John Ellerton, M.D.
Role: PRINCIPAL_INVESTIGATOR
Nevada Cancer Research Foundation (NCRF)
Bohuslav Melichar, M.D.
Role: PRINCIPAL_INVESTIGATOR
Onkologicka klinika, Fakultni nemocnice Olomouc (OUH)
Martin Smakal, M.D.
Role: PRINCIPAL_INVESTIGATOR
Onkologicky stacionar, NH Hospital a.s., nemocnice Horovice (NHH)
Martina Zimovjanova, M.D.
Role: PRINCIPAL_INVESTIGATOR
Onkologicka klinika, Vseobecna fakultni nemocnice v Praze (VFN)
Locations
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California Research Institute (CRI)
Los Angeles, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
Boca Raton Regional Hospital (BRRH)
Boca Raton, Florida, United States
ASCLEPES Research Center(ARC)
Weeki Wachee, Florida, United States
Saint Luke's Cancer Institute(SLCI)
Kansas City, Kansas, United States
University of Kansas Medical Center(KUMC)
Kansas City, Kansas, United States
Anne Arundel Health System Research Institute (AAHS)
Annapolis, Maryland, United States
Massachusetts General Hospital(MGH)
Boston, Massachusetts, United States
Michigan Center of Medical Research(MCMR)
Farmington Hills, Michigan, United States
Metro-Minnesota Community Oncology Research Consortium (MMCORC)
Minneapolis, Minnesota, United States
Nevada Cancer Research Foundation (NCRF)
Las Vegas, Nevada, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States
Onkologicka klinika, Fakultni nemocnice Olomouc (OUH)
Olomouc, I.P. Pavlova 6, Czechia
Onkologicky stacionar, NH Hospital a.s., nemocnice Horovice (NHH)
Hořovice, K Nemocnici, Czechia
Onkologicka klinika, Vseobecna fakultni nemocnice v Praze (VFN)
Prague, U Nemocnice 499/2, Czechia
Countries
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Other Identifiers
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107CS-6
Identifier Type: -
Identifier Source: org_study_id
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