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Protocol # 18-084

Status

Recruiting

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.

Condition

  • Recurrent or Metastatic Breast Cancer

Interventions

  • DHP107
  • IV Paclitaxel

Phase

Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Objective Response Rate(ORR)

Secondary Outcome:

  • Progression free survival(PFS)
  • Overall survival(OS)
  • Time to treatment failure(TTF)
  • Duration of response(DOR)
  • Disease control rate(DCR)
  • Quality of life(QoL)
  • AUC
  • Cmax
  • Tmax

Enrollment

72

Study Start Date

July 25, 2018

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Daehwa Pharmaceutical Co., Ltd.

Source

Daehwa Pharmaceutical Co., Ltd.

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)

Clinicaltrials.gov Identifier

NCT03326102

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.