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.
Title
- Brief Title: Oral Paclitaxel Efficacy Safety and PK in Recurrent and 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
Drug | Synonyms | Arms |
---|
DHP107 | Liporaxel®, Oral Paclitaxel | DHP107 |
IV Paclitaxel | Taxol Injection | IV 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
Name | Type | Description | Interventions |
---|
DHP107 | Experimental | 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. | |
IV paclitaxel | Experimental | Total 24 subject will receive IV paclitaxel 80 mg/m2 weekly.(3 weeks on/1 week off) | |
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).
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: | Recruiting |
Lead Sponsor: | Daehwa Pharmaceutical Co., Ltd. |
Trial Keywords
- Breast Cancer
- DHP107
- Paclitaxel
- Liporaxel
Last Updated
March 13, 2020