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A Phase III Study of NK105 in Patients With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01644890
Recruitment Status : Completed
First Posted : July 19, 2012
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Nippon Kayaku Co., Ltd.

Tracking Information
First Submitted Date  ICMJE July 17, 2012
First Posted Date  ICMJE July 19, 2012
Last Update Posted Date February 3, 2017
Study Start Date  ICMJE July 2012
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2014)
Progression free survival [ Time Frame: 4.2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2012)
Progression free survival [ Time Frame: 2.5 years ]
Change History Complete list of historical versions of study NCT01644890 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase III Study of NK105 in Patients With Breast Cancer
Official Title  ICMJE A Multi-national Phase III Clinical Study Comparing NK105 Versus Paclitaxel in Patients With Metastatic or Recurrent Breast Cancer
Brief Summary 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.
Detailed Description This study is a randomized, open-label, multi-national phase III study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer Nos Metastatic Recurrent
Intervention  ICMJE
  • Drug: NK105
    IV, Weekly
  • Drug: Paclitaxel
    IV, Weekly
Study Arms  ICMJE
  • Experimental: NK105
    Intervention: Drug: NK105
  • Active Comparator: Paclitaxel
    Intervention: Drug: Paclitaxel
Publications * Fujiwara Y, Mukai H, Saeki T, Ro J, Lin YC, Nagai SE, Lee KS, Watanabe J, Ohtani S, Kim SB, Kuroi K, Tsugawa K, Tokuda Y, Iwata H, Park YH, Yang Y, Nambu Y. A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients. Br J Cancer. 2019 Mar;120(5):475-480. doi: 10.1038/s41416-019-0391-z. Epub 2019 Feb 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2017)
436
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2012)
380
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01644890
Other Study ID Numbers  ICMJE A3105301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nippon Kayaku Co., Ltd.
Study Sponsor  ICMJE Nippon Kayaku Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call +81-3-6731-5200 Mon - Fri 9 AM - 5 PM (Japan Time) Nippon Kayaku Co., Ltd.
PRS Account Nippon Kayaku Co., Ltd.
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP