A Study of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
NCT ID: NCT01009775
Last Updated: 2015-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2009-11-30
2012-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma
NCT00281541
Ipilimumab With Carboplatin and Paclitaxel in Patients With Unresectable Stage III and Stage IV Melanoma
NCT01676649
Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma
NCT01127451
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
NCT04099251
Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma
NCT00324155
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Part 1:
Part 1 is a lead-in stage that will confirm if YM155 can be safely administered in combination with docetaxel at a specified dose.
Part 2:
Subjects enrolled in Part 2 will receive YM155 and docetaxel at the dose established during Part 1.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
YM155 plus docetaxel
YM155
intravenous infusion
Docetaxel
intravenous infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
YM155
intravenous infusion
Docetaxel
intravenous infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* No prior systemic treatment or Cytotoxic chemotherapy for advanced melanoma (Stage III or Stage IV)
* If the subject is female, she must be non-pregnant and non-lactating at the Baseline Visit. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period
* Eastern Cooperative Oncology Group (ECOG) performance status \</= 1
* Life expectancy \> 12 weeks
* At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors ({RECIST} version 1.1)
* Subjects with a previous history of non-melanoma malignancy must have undergone curative therapy for all prior malignancies and be considered disease free for at least 5 years
Exclusion Criteria
* Presence or history of brain metastases
* Primary ocular, choroidal or mucosal melanoma
* Known history of positive test for Hepatitis B surface Antigen (HsbAg) or Hepatitis C antibody or history of positive test for Human Immunodeficiency Virus (HIV)
* Hypersensitivity to docetaxel or polysorbate 80
* Neuropathy greater than or equal to Grade 2 at Baseline Visit
* The subject has been previously treated with YM155
* Inadequate marrow, hepatic, and/or renal functions
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Astellas Pharma Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sr. Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of South Alabama
Mobile, Alabama, United States
University of South Alabama
Mobile, Alabama, United States
Arizona Clinical Research Center
Tuscon, Arizona, United States
The Angeles Clinic and Research
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Redwood Regional Medical Group
Sebastopol, California, United States
University of Colorado
Aurora, Colorado, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Univ. of Michigan Health System
Ann Arbor, Michigan, United States
Univ. of Michigan Health System
Ann Arbor, Michigan, United States
St. Lukes Hospital Cancer Center
Bethlehem, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
London Regional Cancer Centre
London, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-015738-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
155-CL-034
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.