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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01009775
First received: November 6, 2009
Last updated: March 19, 2013
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Melanoma
Drug: YM155
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Open-Label Study Of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 6-month Progression-free survival [ Time Frame: After the last non-progressing subject completes 6 months or discontinues the treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 1 year survival [ Time Frame: After the last non-progressing subject completes 6 months or discontinues the treatment ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 years after the last subject discontinues treatment ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: After the last non-progressing subject completes 6 months or discontinues the treatment ] [ Designated as safety issue: No ]
  • Clinical benefit rate [ Time Frame: After the last non-progressing subject completes 6 months or discontinues the treatment ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: After the last non-progressing subject completes 6 months or discontinues the treatment ] [ Designated as safety issue: No ]
  • Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs) [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: November 2009
Study Completion Date: August 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YM155 plus docetaxel Drug: YM155
intravenous infusion
Drug: Docetaxel
intravenous infusion
Other Name: Taxotere

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 </= 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009775

Locations
United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36619/36604
University of South Alabama
Mobile, Alabama, United States, 36604
United States, Arizona
Arizona Clinical Research Center
Tuscon, Arizona, United States, 85715
United States, California
The Angeles Clinic and Research
Los Angeles, California, United States, 90025
UCLA
Los Angeles, California, United States, 90095
Redwood Regional Medical Group
Sebastopol, California, United States, 95472
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Michigan
Univ. of Michigan Health System
Ann Arbor, Michigan, United States, 48109/48109
Univ. of Michigan Health System
Ann Arbor, Michigan, United States, 48105
United States, Pennsylvania
St. Lukes Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Ontario
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Sr. Medical Director Astellas Pharma Global Development
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01009775     History of Changes
Other Study ID Numbers: 155-CL-034, 2009-015738-31
Study First Received: November 6, 2009
Last Updated: March 19, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Astellas Pharma Inc:
Melanoma, Stage III
Melanoma, Stage IV
YM 155
Metastatic Melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014