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

Primary Purpose

Melanoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
YM155
Docetaxel
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Stage III, Melanoma, Stage IV, YM 155, Metastatic Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Alabama
  • University of South Alabama
  • Arizona Clinical Research Center
  • The Angeles Clinic and Research
  • UCLA
  • Redwood Regional Medical Group
  • University of Colorado
  • H. Lee Moffitt Cancer Center
  • Univ. of Michigan Health System
  • Univ. of Michigan Health System
  • St. Lukes Hospital Cancer Center
  • MD Anderson Cancer Center
  • London Regional Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

YM155 plus docetaxel

Arm Description

Outcomes

Primary Outcome Measures

6-month Progression-free survival

Secondary Outcome Measures

Objective response rate (proportion of subjects with complete response or partial response)
1 year survival
Overall survival
Duration of response
Clinical benefit rate
Time to response
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)

Full Information

First Posted
November 6, 2009
Last Updated
August 20, 2015
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01009775
Brief Title
A Study of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
Official Title
A Phase II, Multicenter, Open-Label Study Of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Melanoma, Stage III, Melanoma, Stage IV, YM 155, Metastatic Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YM155 plus docetaxel
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
YM155
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
intravenous infusion
Primary Outcome Measure Information:
Title
6-month Progression-free survival
Time Frame
After the last non-progressing subject completes 6 months or discontinues the treatment
Secondary Outcome Measure Information:
Title
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
Title
1 year survival
Time Frame
After the last non-progressing subject completes 6 months or discontinues the treatment
Title
Overall survival
Time Frame
2 years after the last subject discontinues treatment
Title
Duration of response
Time Frame
After the last non-progressing subject completes 6 months or discontinues the treatment
Title
Clinical benefit rate
Time Frame
After the last non-progressing subject completes 6 months or discontinues the treatment
Title
Time to response
Time Frame
After the last non-progressing subject completes 6 months or discontinues the treatment
Title
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Time Frame
Monthly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Medical Director
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36619/36604
Country
United States
Facility Name
Arizona Clinical Research Center
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
The Angeles Clinic and Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Redwood Regional Medical Group
City
Sebastopol
State/Province
California
ZIP/Postal Code
95472
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Univ. of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Univ. of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109/48109
Country
United States
Facility Name
St. Lukes Hospital Cancer Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=562
Description
Link to results on JAPIC

Learn more about this trial

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

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