Clinical trial NCT03326102: Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer
Official title: A Multi-national,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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent or Metastatic Breast Cancer
Keywords: Breast Cancer
DHP107
Paclitaxel
Liporaxel
Lead sponsor: Daehwa Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-10-30
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be assigned to DHP107 or IV paclitaxel in a ratio of 2:1 (n=48 to DHP107 and n=24 to IV paclitaxel)
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Key Inclusion Criteria:

1. Subjects with confirmed diagnosis of recurrent or metastatic breast cancer based on histopathology examination
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).

Key Exclusion Criteria:

1. Subjects who have received prior taxane therapy in the metastatic setting
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).

Primary outcomes:
measure: Objective Response Rate(ORR)
timeFrame: Every 8 weeks upto 18 months from randomization date
Secondary outcomes:
measure: Progression free survival(PFS)
timeFrame: Up to 18 months from randomization date
measure: Overall survival(OS)
timeFrame: Up to 36 months from FPI
measure: Time to treatment failure(TTF)
timeFrame: Up to 18 months from randomization date
measure: Duration of response(DOR)
timeFrame: Up to 18 months from randomization date
measure: Disease control rate(DCR)
timeFrame: Up to 18 months from randomization date
measure: Quality of life(QoL)
timeFrame: after randomization(C1D1), D1 of every 3rd cycle(each cycle consists of 28 days) up to 18 months
measure: PK
timeFrame: The 12 eligible subjects will receive DHP107 and be taken blood samples for PK analysis on Day 1, 8 of Cycle 1
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: California Research Institute (CRI)
state: California
city: San Francisco
country: United States
facility: University of California San Francisco (UCSF)
state: California
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital (BRRH)
state: Florida
city: Weeki Wachee
country: United States
facility: ASCLEPES Research Center(ARC)
state: Florida
city: Kansas City
country: United States
facility: Saint Luke's Cancer Institute(SLCI)
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Medical Center(KUMC)
state: Kansas
city: Annapolis
country: United States
facility: Anne Arundel Health System Research Institute (AAHS)
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital(MGH)
state: Massachusetts
city: Farmington Hills
country: United States
facility: Michigan Center of Medical Research(MCMR)
state: Michigan
city: Minneapolis
country: United States
facility: Metro-Minnesota Community Oncology Research Consortium (MMCORC)
state: Minnesota
city: Las Vegas
country: United States
facility: Nevada Cancer Research Foundation (NCRF)
state: Nevada
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC)
state: Pennsylvania
city: Olomouc
country: Czechia
facility: Onkologicka klinika, Fakultni nemocnice Olomouc (OUH)
state: I.P. Pavlova 6
city: Hořovice
country: Czechia
facility: Onkologicky stacionar, NH Hospital a.s., nemocnice Horovice (NHH)
state: K Nemocnici
city: Praha 2
country: Czechia
facility: Onkologicka klinika, Vseobecna fakultni nemocnice v Praze (VFN)
state: U Nemocnice 499/2
Study officials:
affiliation: University of California, San Francisco
name: Hope Rugo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Anne Arundel Health System Research Institute (AAHS)
name: David Weng, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital (MGH)
name: Neelima Vidula, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh Medical Center (UPMC)
name: Adam Brufsky, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Luke's Cancer Institute(SLCI)
name: Timothy Pluard, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas Medical Center(KUMC)
name: Priyanka Sharma, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Boca Raton Regional Hospital (BRRH)
name: Jane Skelton, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: ASCLEPES Research Center(ARC)
name: Richard Caradonna, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Metro-Minnesota Community Oncology Research Consortium (MMCORC)
name: Yan Ji, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan Center of Medical Research(MCMR)
name: Craig Gordon, D.O.
role: PRINCIPAL_INVESTIGATOR
affiliation: California Research Institute (CRI)
name: Ghassan Aljazayrly, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Nevada Cancer Research Foundation (NCRF)
name: John Ellerton, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Onkologicka klinika, Fakultni nemocnice Olomouc (OUH)
name: Bohuslav Melichar, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Onkologicky stacionar, NH Hospital a.s., nemocnice Horovice (NHH)
name: Martin Smakal, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Onkologicka klinika, Vseobecna fakultni nemocnice v Praze (VFN)
name: Martina Zimovjanova, M.D.
role: PRINCIPAL_INVESTIGATOR
References: