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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Drug: YM155; Drug: Docetaxel

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Centre
• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • University of South Alabama
    • Mobile, Alabama, United States, 36619/36604
      • University of South Alabama
  • Arizona
    • Tuscon, Arizona, United States, 85715
      • Arizona Clinical Research Center
  • California
    • Los Angeles, California, United States, 90095
      • UCLA
    • Los Angeles, California, United States, 90025
      • The Angeles Clinic and Research
    • Sebastopol, California, United States, 95472
      • Redwood Regional Medical Group
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Univ. of Michigan Health System
    • Ann Arbor, Michigan, United States, 48109/48109
      • Univ. of Michigan Health System
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Lukes Hospital Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • Md Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YM155 plus docetaxel	Drug: YM155; intravenous infusion; Drug: Docetaxel; intravenous infusion; Other Names: Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
6-month Progression-free survival	After the last non-progressing subject completes 6 months or discontinues the treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Investigators: Study Director: Sr. Medical Director, Astellas Pharma Global Development

Publications and helpful links

Helpful Links

• Link to results on JAPIC

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: November 6, 2009
• First Submitted That Met QC Criteria: November 6, 2009
• First Posted (Estimate): November 9, 2009

Study Record Updates

• Last Update Posted (Estimate): September 4, 2015
• Last Update Submitted That Met QC Criteria: August 20, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Metastatic Melanoma; Melanoma, Stage III; Melanoma, Stage IV; YM 155
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: 155-CL-034; 2009-015738-31 (EudraCT Number)