Back to resultsOral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer (OPERA)
Primary Purpose
Recurrent or Metastatic Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DHP107
IV Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent or Metastatic Breast Cancer focused on measuring Breast Cancer, DHP107, Paclitaxel, Liporaxel
Eligibility Criteria
Key Inclusion Criteria:
- 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 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).
Key Exclusion Criteria:
- 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 with neuropathy grade ≥2 based on CTCAE v4.03 at the time of study entry
- Subjects with symptomatic, untreated metastases to the central nervous system (CNS) at the time of screening.
- Subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (C1D1).
Sites / Locations
- California Research Institute (CRI)Recruiting
- University of California San Francisco (UCSF)Recruiting
- Boca Raton Regional Hospital (BRRH)
- ASCLEPES Research Center(ARC)Recruiting
- Saint Luke's Cancer Institute(SLCI)Recruiting
- University of Kansas Medical Center(KUMC)Recruiting
- Anne Arundel Health System Research Institute (AAHS)
- Massachusetts General Hospital(MGH)Recruiting
- Michigan Center of Medical Research(MCMR)Recruiting
- Metro-Minnesota Community Oncology Research Consortium (MMCORC)Recruiting
- Nevada Cancer Research Foundation (NCRF)Recruiting
- University of Pittsburgh Medical Center (UPMC)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
DHP107
IV paclitaxel
Arm Description
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.
Total 24 subject will receive IV paclitaxel 80 mg/m2 weekly.(3 weeks on/1 week off)
Outcomes
Primary Outcome Measures
Objective Response Rate(ORR)
ORR is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria
Secondary Outcome Measures
Progression free survival(PFS)
PFS is defined as the time from date of randomization until the date of first documented progression or death.
Overall survival(OS)
OS is defined as the time from the date of inclusion to the date of death.
Time to treatment failure(TTF)
TTF is defined as the time from the randomization date to the date of discontinuation of treatment, regardless of the cause.
Duration of response(DOR)
DOR is the time between the initial response to therapy and subsequent disease progression or relapse.
Disease control rate(DCR)
DCR is defined as the percentage of subjects who were evaluated for complete response(CR), partial response(PR), and stable disease(SD) as the best response among from randomization.
Quality of life(QoL)
Evaluate changes compared to baseline using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
AUC
Area under the plasma concentration-time curve
Cmax
Maximum concentration
Tmax
Time to reach observed maximum concentration
Full Information
NCT ID
NCT03326102
First Posted
October 19, 2017
Last Updated
March 11, 2020
Sponsor
Daehwa Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03326102
Brief Title
Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer
Acronym
OPERA
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daehwa Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent or Metastatic Breast Cancer
Keywords
Breast Cancer, DHP107, Paclitaxel, Liporaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DHP107
Arm Type
Experimental
Arm Description
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.
Arm Title
IV paclitaxel
Arm Type
Experimental
Arm Description
Total 24 subject will receive IV paclitaxel 80 mg/m2 weekly.(3 weeks on/1 week off)
Intervention Type
Drug
Intervention Name(s)
DHP107
Other Intervention Name(s)
Liporaxel®, Oral Paclitaxel
Intervention Description
DHP107 200mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days
Intervention Type
Drug
Intervention Name(s)
IV Paclitaxel
Other Intervention Name(s)
Taxol Injection
Intervention Description
IV Paclitaxel 80 mg/m2 QW (3 weeks on/1 week off)
Primary Outcome Measure Information:
Title
Objective Response Rate(ORR)
Description
ORR is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria
Time Frame
Every 8 weeks upto 18 months from randomization date
Secondary Outcome Measure Information:
Title
Progression free survival(PFS)
Description
PFS is defined as the time from date of randomization until the date of first documented progression or death.
Time Frame
Up to 18 months from randomization date
Title
Overall survival(OS)
Description
OS is defined as the time from the date of inclusion to the date of death.
Time Frame
Up to 36 months from FPI
Title
Time to treatment failure(TTF)
Description
TTF is defined as the time from the randomization date to the date of discontinuation of treatment, regardless of the cause.
Time Frame
Up to 18 months from randomization date
Title
Duration of response(DOR)
Description
DOR is the time between the initial response to therapy and subsequent disease progression or relapse.
Time Frame
Up to 18 months from randomization date
Title
Disease control rate(DCR)
Description
DCR is defined as the percentage of subjects who were evaluated for complete response(CR), partial response(PR), and stable disease(SD) as the best response among from randomization.
Time Frame
Up to 18 months from randomization date
Title
Quality of life(QoL)
Description
Evaluate changes compared to baseline using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time Frame
after randomization(C1D1), D1 of every 3rd cycle(each cycle consists of 28 days) up to 18 months
Title
AUC
Description
Area under the plasma concentration-time curve
Time Frame
on Day 1 of Cycle 1(each cycle consists of 28days) at predose, 1, 2, 3, 4, 6 and 10 hrs post dose (before the 2nd dose on Day 1) and on Day 8 of Cycle 1 at predose (before the 1st dose on Day 8)
Title
Cmax
Description
Maximum concentration
Time Frame
on Day 1 of Cycle 1(each cycle consists of 28days) at predose, 1, 2, 3, 4, 6 and 10 hrs post dose (before the 2nd dose on Day 1) and on Day 8 of Cycle 1 at predose (before the 1st dose on Day 8)
Title
Tmax
Description
Time to reach observed maximum concentration
Time Frame
on Day 1 of Cycle 1(each cycle consists of 28days) at predose, 1, 2, 3, 4, 6 and 10 hrs post dose (before the 2nd dose on Day 1) and on Day 8 of Cycle 1 at predose (before the 1st dose on Day 8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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 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).
Key Exclusion Criteria:
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 with neuropathy grade ≥2 based on CTCAE v4.03 at the time of study entry
Subjects with symptomatic, untreated metastases to the central nervous system (CNS) at the time of screening.
Subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (C1D1).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hope Rugo, M.D.
Phone
415-353-7070
Email
Hope.Rugo@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hope Rugo, M.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Weng, M.D.
Organizational Affiliation
Anne Arundel Health System Research Institute (AAHS)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neelima Vidula, M.D.
Organizational Affiliation
Massachusetts General Hospital (MGH)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam Brufsky, M.D.
Organizational Affiliation
University of Pittsburgh Medical Center (UPMC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timothy Pluard, M.D.
Organizational Affiliation
Saint Luke's Cancer Institute(SLCI)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Priyanka Sharma, M.D.
Organizational Affiliation
University of Kansas Medical Center(KUMC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jane Skelton, M.D.
Organizational Affiliation
Boca Raton Regional Hospital (BRRH)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Caradonna, M.D.
Organizational Affiliation
ASCLEPES Research Center(ARC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yan Ji, M.D.
Organizational Affiliation
Metro-Minnesota Community Oncology Research Consortium (MMCORC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craig Gordon, D.O.
Organizational Affiliation
Michigan Center of Medical Research(MCMR)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ghassan Aljazayrly, M.D.
Organizational Affiliation
California Research Institute (CRI)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Ellerton, M.D.
Organizational Affiliation
Nevada Cancer Research Foundation (NCRF)
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Research Institute (CRI)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghassan Aljazayrly, M.D.
Facility Name
University of California San Francisco (UCSF)
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rugo Hope, M.D.
Phone
415-353-7070
Email
Hope.Rugo@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Michelle Melisko, M.D.
Facility Name
Boca Raton Regional Hospital (BRRH)
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Terminated
Facility Name
ASCLEPES Research Center(ARC)
City
Weeki Wachee
State/Province
Florida
ZIP/Postal Code
34607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Caradonna, M.D.
Facility Name
Saint Luke's Cancer Institute(SLCI)
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Pluard, M.D.
Facility Name
University of Kansas Medical Center(KUMC)
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priyanka Sharma, M.D.
Facility Name
Anne Arundel Health System Research Institute (AAHS)
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Individual Site Status
Terminated
Facility Name
Massachusetts General Hospital(MGH)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vidula Neelima, M.D.
Phone
617-724-4000
Facility Name
Michigan Center of Medical Research(MCMR)
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Gordon, D.O.
Facility Name
Metro-Minnesota Community Oncology Research Consortium (MMCORC)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Ji, M.D.
Facility Name
Nevada Cancer Research Foundation (NCRF)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Ellerton, M.D.
Facility Name
University of Pittsburgh Medical Center (UPMC)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Terminated
12. IPD Sharing Statement
Learn more about this trial
Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer
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