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Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer (OPERA)

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ClinicalTrials.gov Identifier: NCT03326102
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Daehwa Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Recurrent or Metastatic Breast Cancer Drug: DHP107 Drug: IV Paclitaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 25, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: 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.

Drug: DHP107
DHP107 200mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days
Other Name: Liporaxel®, Oral Paclitaxel

Experimental: IV paclitaxel
Total 24 subject will receive IV paclitaxel 80 mg/m2 weekly.(3 weeks on/1 week off)
Drug: IV Paclitaxel
IV Paclitaxel 80 mg/m2 QW (3 weeks on/1 week off)
Other Name: Taxol Injection




Primary Outcome Measures :
  1. Objective Response Rate(ORR) [ Time Frame: Every 8 weeks upto 18 months from randomization date ]
    ORR is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria


Secondary Outcome Measures :
  1. Progression free survival(PFS) [ Time Frame: Up to 18 months from randomization date ]
    PFS is defined as the time from date of randomization until the date of first documented progression or death.

  2. Overall survival(OS) [ Time Frame: Up to 36 months from FPI ]
    OS is defined as the time from the date of inclusion to the date of death.

  3. Time to treatment failure(TTF) [ Time Frame: Up to 18 months from randomization date ]
    TTF is defined as the time from the randomization date to the date of discontinuation of treatment, regardless of the cause.

  4. Duration of response(DOR) [ Time Frame: Up to 18 months from randomization date ]
    DOR is the time between the initial response to therapy and subsequent disease progression or relapse.

  5. Disease control rate(DCR) [ Time Frame: Up to 18 months from randomization date ]
    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.

  6. Quality of life(QoL) [ Time Frame: after randomization(C1D1), D1 of every 3rd cycle(each cycle consists of 28 days) up to 18 months ]
    Evaluate changes compared to baseline using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

  7. AUC [ 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) ]
    Area under the plasma concentration-time curve

  8. Cmax [ 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) ]
    Maximum concentration

  9. Tmax [ 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) ]
    Time to reach observed maximum concentration



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326102


Contacts
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Contact: Hope Rugo, M.D. 415-353-7070 Hope.Rugo@ucsf.edu

Locations
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United States, California
California Research Institute (CRI) Recruiting
Los Angeles, California, United States, 90027
Contact: Ghassan Aljazayrly, M.D.         
University of California San Francisco (UCSF) Recruiting
San Francisco, California, United States, 94115
Contact: Rugo Hope, M.D.    415-353-7070    Hope.Rugo@ucsf.edu   
Contact: Michelle Melisko, M.D.         
United States, Florida
Boca Raton Regional Hospital (BRRH) Terminated
Boca Raton, Florida, United States, 33486
ASCLEPES Research Center(ARC) Recruiting
Weeki Wachee, Florida, United States, 34607
Contact: Richard Caradonna, M.D.         
United States, Kansas
Saint Luke's Cancer Institute(SLCI) Recruiting
Kansas City, Kansas, United States, 64111
Contact: Timothy Pluard, M.D.         
University of Kansas Medical Center(KUMC) Recruiting
Kansas City, Kansas, United States, 66160
Contact: Priyanka Sharma, M.D.         
United States, Maryland
Anne Arundel Health System Research Institute (AAHS) Terminated
Annapolis, Maryland, United States, 21401
United States, Massachusetts
Massachusetts General Hospital(MGH) Recruiting
Boston, Massachusetts, United States, 02114
Contact: Vidula Neelima, M.D.    617-724-4000      
United States, Michigan
Michigan Center of Medical Research(MCMR) Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Craig Gordon, D.O.         
United States, Minnesota
Metro-Minnesota Community Oncology Research Consortium (MMCORC) Recruiting
Minneapolis, Minnesota, United States, 55426
Contact: Yan Ji, M.D.         
United States, Nevada
Nevada Cancer Research Foundation (NCRF) Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John Ellerton, M.D.         
United States, Pennsylvania
University of Pittsburgh Medical Center (UPMC) Terminated
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Daehwa Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Hope Rugo, M.D. University of California, San Francisco
Principal Investigator: David Weng, M.D. Anne Arundel Health System Research Institute (AAHS)
Principal Investigator: Neelima Vidula, M.D. Massachusetts General Hospital (MGH)
Principal Investigator: Adam Brufsky, M.D. University of Pittsburgh Medical Center (UPMC)
Principal Investigator: Timothy Pluard, M.D. Saint Luke's Cancer Institute(SLCI)
Principal Investigator: Priyanka Sharma, M.D. University of Kansas Medical Center(KUMC)
Principal Investigator: Jane Skelton, M.D. Boca Raton Regional Hospital (BRRH)
Principal Investigator: Richard Caradonna, M.D. ASCLEPES Research Center(ARC)
Principal Investigator: Yan Ji, M.D. Metro-Minnesota Community Oncology Research Consortium (MMCORC)
Principal Investigator: Craig Gordon, D.O. Michigan Center of Medical Research(MCMR)
Principal Investigator: Ghassan Aljazayrly, M.D. California Research Institute (CRI)
Principal Investigator: John Ellerton, M.D. Nevada Cancer Research Foundation (NCRF)
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Responsible Party: Daehwa Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03326102    
Other Study ID Numbers: 107CS-6
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daehwa Pharmaceutical Co., Ltd.:
Breast Cancer
DHP107
Paclitaxel
Liporaxel
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action