Clinical Trial: NCT03326102
Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | Daehwa Pharmaceutical Co., Ltd. |
| Information Provided By: | Daehwa Pharmaceutical Co., Ltd. |
| Last Update Posted: | 2024-02-16 |
Study Overview
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.
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)
Conditions
Recurrent or Metastatic Breast Cancer
Intervention / Treatment
- Drug: DHP107
- Drug: IV Paclitaxel
Other Study ID Numbers
- 107CS-6
Start Date (Actual)
2018-07-06
Primary Completion Date (Actual)
2022-12-13
Study Completion Date (Actual)
2022-12-13
Enrollment (Actual)
72
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Daehwa Pharmaceutical Co., Ltd. |
| Information Provided By: | Daehwa Pharmaceutical Co., Ltd. |
| Last Update Posted: | 2024-02-16 |
Study Overview
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.
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)
Conditions
Recurrent or Metastatic Breast Cancer
Intervention / Treatment
- Drug: DHP107
- Drug: IV Paclitaxel
Other Study ID Numbers
- 107CS-6
Start Date (Actual)
2018-07-06
Primary Completion Date (Actual)
2022-12-13
Study Completion Date (Actual)
2022-12-13
Enrollment (Actual)
72
Study Type
Interventional
Phase
Phase 2