Clinical Trials /

Oral Paclitaxel Efficacy Safety and PK in Recurrent and metAstatic Breast Cancer

NCT03326102

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: PK, Efficacy and Safety Study of DHP107 in Patients With Recurrent or Metastatic Breast Cancer
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: 107CS-6
  • NCT ID: NCT03326102

Conditions

  • Recurrent or Metastatic Breast Cancer

Interventions

DrugSynonymsArms
DHP107Liporaxel®, Oral PaclitaxelDHP107
IV PaclitaxelTaxol InjectionIV paclitaxel

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.

Trial Arms

NameTypeDescriptionInterventions
DHP107Experimental[Part 1] The first 12 eligible subjects will receive DHP107 and be taken blood samples for PK analysis on Day 1, 8 of cycle 1. [Part 2] total 48 subjects (including part 1 subjects) will receive DHP107 200 mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days.
  • DHP107
IV paclitaxelExperimental[Part 2] 24 subject will receive IV paclitaxel 80 mg/m2 weekly.
  • IV Paclitaxel

Eligibility 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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate(ORR)
Time Frame:Every 8 weeks upto 18 months from randomization date
Safety Issue:
Description:ORR is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria

Secondary Outcome Measures

Measure:Progression free survival(PFS)
Time Frame:Up to 18 months from randomization date
Safety Issue:
Description:PFS is defined as the time from date of randomization until the date of first documented progression or death.
Measure:Overall survival(OS)
Time Frame:Up to 36 months from FPI
Safety Issue:
Description:OS is defined as the time from the date of inclusion to the date of death.
Measure:Time to treatment failure(TTF)
Time Frame:Up to 18 months from randomization date
Safety Issue:
Description:TTF is defined as the time from the randomization date to the date of discontinuation of treatment, regardless of the cause.
Measure:Duration of response(DOR)
Time Frame:Up to 18 months from randomization date
Safety Issue:
Description:DOR is the time between the initial response to therapy and subsequent disease progression or relapse.
Measure:Disease control rate(DCR)
Time Frame:Up to 18 months from randomization date
Safety Issue:
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.
Measure:Quality of life(QoL)
Time Frame:after randomization(C1D1), D1 of every 3rd cycle(each cycle consists of 28 days) up to 18 months
Safety Issue:
Description:Evaluate changes compared to baseline using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Measure: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)
Safety Issue:
Description:Area under the plasma concentration-time curve
Measure: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)
Safety Issue:
Description:Maximum concentration
Measure: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)
Safety Issue:
Description:Time to reach observed maximum concentration

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Daehwa Pharmaceutical Co., Ltd.

Trial Keywords

  • Breast Cancer
  • DHP107
  • Paclitaxel
  • Liporaxel

Last Updated

October 25, 2017