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A Phase II, Multicenter, Open-Label Study Of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

A Phase II, Multicenter, Open-Label Study Of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6-month Progression-free survival

Outcome Time Frame:

After the last non-progressing subject completes 6 months or discontinues the treatment

Safety Issue:

No

Principal Investigator

Sr. Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Food and Drug Administration

Study ID:

155-CL-034

NCT ID:

NCT01009775

Start Date:

November 2009

Completion Date:

August 2012

Related Keywords:

  • Melanoma
  • Melanoma, Stage III
  • Melanoma, Stage IV
  • YM 155
  • Metastatic Melanoma
  • Melanoma

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
University of ColoradoDenver, Colorado  80217
Arizona Clinical Research CenterTucson, Arizona  85712
H. Lee Moffitt Cancer CenterTampa, Florida  33612
UCLALos Angeles, California  90095
Redwood Regional Medical GroupSanta Rosa, California  95403
St. Lukes Hospital Cancer CenterBethlehem, Pennsylvania  18015
University of South AlabamaMobile, Alabama  36693
The Angeles Clinic and ResearchLos Angeles, California  90025
Univ. of Michigan Health SystemAnn Arbor, Michigan  48109/48109