A Study of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma

Phase 2

Completed

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.

Detailed Description: All subjects will receive YM155 and docetaxel given in a 21-day cycle. The docetaxel dose will be established based on the findings of the lead-in portion of the study (Part 1). Once the docetaxel dose is established, Part 2 enrollment will begin.

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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
YM155 plus docetaxel	YM155	-
YM155 plus docetaxel	Docetaxel	-

Primary Outcome Measures

Name	Time	Method
6-month Progression-free survival	After the last non-progressing subject completes 6 months or discontinues the treatment

Secondary Outcome Measures

Name	Time	Method
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
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
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
Time to response	After the last non-progressing subject completes 6 months or discontinues the treatment
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)	Monthly

Locations (11): 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
St. Lukes Hospital Cancer Center
🇺🇸
Bethlehem, Pennsylvania, United States
MD Anderson Cancer Center
🇺🇸
Houston, Texas, United States
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University of South Alabama
🇺🇸Mobile, Alabama, United States