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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
Results First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Nippon Kayaku Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Nos Metastatic Recurrent Drug: NK105 Drug: Paclitaxel Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: NK105 Drug: NK105
IV, Weekly

Active Comparator: Paclitaxel Drug: Paclitaxel
IV, Weekly




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Baseline, every 6 weeks of study treatment period, and end of study, ]

    PFS is defined as the period from the day of randomization until the first observation of lesion progression or death from any cause. Disease progression is defined as PD according to RECIST Ver. 1.1.

    Assessment period was from the day of randomisation until the first observation of lesion progression or death



Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Baseline, every 6 weeks of study treatment period, and end of study. ]

    OS is defined as the period from the day of randomization until the day of death from any cause.

    Assessment period was from the day of randomisation until the first observation of lesion progression or death


  2. Overall Response Rate [ Time Frame: Baseline, every 6 weeks of study treatment period, and end of study. ]

    ORR is the proportion of patients who are assessed as complete response or partial response as the best overall response among evaluable patients, according to RECIST Ver.1.1.

    Assessment period was from the day of randomisation until the first observation of lesion progression or death




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644890


Locations
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Japan
Japan Sites
Tokyo, Etc., Japan
Sponsors and Collaborators
Nippon Kayaku Co., Ltd.
Investigators
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Study Director: Call +81-3-6731-5200 Mon - Fri 9 AM - 5 PM (Japan Time) Nippon Kayaku Co., Ltd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nippon Kayaku Co., Ltd.
ClinicalTrials.gov Identifier: NCT01644890     History of Changes
Other Study ID Numbers: A3105301
First Posted: July 19, 2012    Key Record Dates
Results First Posted: July 29, 2019
Last Update Posted: July 29, 2019
Last Verified: February 2016

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

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action