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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2013
• Main ID: NCT01009775
• Date of registration: 06/11/2009
• Primary sponsor: Astellas Pharma Inc
• Public title: A Study of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
• Scientific title: A Phase II, Multicenter, Open-Label Study Of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
• Date of first enrolment: November 2009
• Target sample size: 64
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01009775
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada, United States

Contacts

• Name: Sr. Medical Director
• Affiliation: Astellas Pharma Global Development

Key inclusion & exclusion criteria

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
- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Melanoma

Intervention(s)

Drug: Docetaxel

Drug: YM155

Primary Outcome(s)

6-month Progression-free survival [Time Frame: After the last non-progressing subject completes 6 months or discontinues the treatment]

Secondary Outcome(s)

1 year survival [Time Frame: After the last non-progressing subject completes 6 months or discontinues the treatment]

Clinical benefit rate [Time Frame: After the last non-progressing subject completes 6 months or discontinues the treatment]

Duration of response [Time Frame: After the last non-progressing subject completes 6 months or discontinues the treatment]

Objective response rate (proportion of subjects with complete response or partial response) [Time Frame: After the last non-progressing subject completes 6 months or discontinues the treatment]

Overall survival [Time Frame: 2 years after the last subject discontinues treatment]

Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs) [Time Frame: Monthly]

Time to response [Time Frame: After the last non-progressing subject completes 6 months or discontinues the treatment]

Secondary ID(s)

155-CL-034

2009-015738-31

Source(s) of Monetary Support

Please refer to primary and secondary sponsors