A Phase III Study of NK105 in Patients With Breast Cancer

Clinical Trial Description

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

Study Design

See also
Status	Clinical Trial	Phase
Completed	`NCT01554371` - Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies	Phase 1/Phase 2
Completed	`NCT01703754` - Adenoviral Vector Monotherapy or Combination With Chemotherapy in Subjects With Recurrent/Metastatic Breast Cancer.	Phase 2
Completed	`NCT01711502` - Epidemiology and Management of Metastatic Breast Cancer	N/A
Recruiting	`NCT01993498` - Chronic Toxicities Related to Treatment in Patients With Localized Cancer	N/A

See also

Status

Clinical Trial

Phase

Completed

NCT01554371 - Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies

Phase 1/Phase 2

Completed

NCT01703754 - Adenoviral Vector Monotherapy or Combination With Chemotherapy in Subjects With Recurrent/Metastatic Breast Cancer.

Phase 2

Completed

NCT01711502 - Epidemiology and Management of Metastatic Breast Cancer

N/A

Recruiting

NCT01993498 - Chronic Toxicities Related to Treatment in Patients With Localized Cancer

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT01644890
Study type	Interventional
Source	Nippon Kayaku Co., Ltd.
Contact
Status	Completed
Phase	Phase 3
Start date	July 2012
Completion date	January 2017

A Phase III Study of NK105 in Patients With Breast Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms