A Phase III Study of NK105 in Patients With Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Nippon Kayaku Co.,Ltd.
Sponsor:
Information provided by (Responsible Party):
Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01644890
First received: July 17, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent breast cancer.


Condition Intervention Phase
Breast Cancer Nos Metastatic Recurrent
Drug: NK105
Drug: Paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-national Phase III Clinical Study Comparing NK105 Versus Paclitaxel in Patients With Metastatic or Recurrent Breast Cancer

Resource links provided by NLM:


Further study details as provided by Nippon Kayaku Co.,Ltd.:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 4.2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 414
Study Start Date: July 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NK105 Drug: NK105
IV, Weekly
Active Comparator: Paclitaxel Drug: Paclitaxel
IV, Weekly

Detailed Description:

This study is a randomized, open-label, multi-national phase III study.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent of the patient signed by herself.
  • Histologically confirmed metastatic or recurrent adenocarcinoma of the breast.
  • Aged 20 to 74 at the time of informed consent.

Exclusion Criteria:

  • Prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent breast cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644890

Contacts
Contact: Contact: Nippon Kayaku Co., Ltd. +81-3-3237-5111

Locations
Japan
Japan Sites Recruiting
Tokyo, etc., Japan
Sponsors and Collaborators
Nippon Kayaku Co.,Ltd.
Investigators
Study Director: Call +81-3-3237-5111 Mon - Fri 9 AM - 5 PM (Japan Time) Nippon Kayaku Co.,Ltd.
  More Information

No publications provided

Responsible Party: Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01644890     History of Changes
Other Study ID Numbers: A3105301
Study First Received: July 17, 2012
Last Updated: June 4, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Nippon Kayaku Co.,Ltd.:
NK105, Paclitaxel, Breast cancer, Micelle

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014