Trials / Completed
CompletedNCT03326102
Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Daehwa Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DHP107 | DHP107 200mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days |
| DRUG | IV Paclitaxel | IV Paclitaxel 80 mg/m2 QW (3 weeks on/1 week off) |
Timeline
- Start date
- 2018-07-06
- Primary completion
- 2022-12-13
- Completion
- 2022-12-13
- First posted
- 2017-10-30
- Last updated
- 2024-02-16
Locations
15 sites across 2 countries: United States, Czechia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03326102. Inclusion in this directory is not an endorsement.