A Study of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
A Phase II, Multicenter, Open-Label Study Of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
2 other identifiers
interventional
64
2 countries
13
Brief Summary
The purpose of the study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel in subjects with Stage III (unresectable) and Stage IV melanoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2009
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 6, 2009
CompletedFirst Posted
Study publicly available on registry
November 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedSeptember 4, 2015
August 1, 2015
1.3 years
November 6, 2009
August 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6-month Progression-free survival
After the last non-progressing subject completes 6 months or discontinues the treatment
Secondary Outcomes (7)
Objective response rate (proportion of subjects with complete response or partial response)
After the last non-progressing subject completes 6 months or discontinues the treatment
1 year survival
After the last non-progressing subject completes 6 months or discontinues the treatment
Overall survival
2 years after the last subject discontinues treatment
Duration of response
After the last non-progressing subject completes 6 months or discontinues the treatment
Clinical benefit rate
After the last non-progressing subject completes 6 months or discontinues the treatment
- +2 more secondary outcomes
Study Arms (1)
YM155 plus docetaxel
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma
- 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
You may not qualify if:
- Major surgery within 21 days of the Baseline Visit
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
University of South Alabama
Mobile, Alabama, 36604, United States
University of South Alabama
Mobile, Alabama, 36619/36604, United States
Arizona Clinical Research Center
Tuscon, Arizona, 85715, United States
The Angeles Clinic and Research
Los Angeles, California, 90025, United States
UCLA
Los Angeles, California, 90095, United States
Redwood Regional Medical Group
Sebastopol, California, 95472, United States
University of Colorado
Aurora, Colorado, 80045, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Univ. of Michigan Health System
Ann Arbor, Michigan, 48105, United States
Univ. of Michigan Health System
Ann Arbor, Michigan, 48109/48109, United States
St. Lukes Hospital Cancer Center
Bethlehem, Pennsylvania, 18015, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sr. Medical Director
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2009
First Posted
November 9, 2009
Study Start
November 1, 2009
Primary Completion
March 1, 2011
Study Completion
August 1, 2012
Last Updated
September 4, 2015
Record last verified: 2015-08