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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01009775
• Other study ID #: 155-CL-034
• Secondary ID: 2009-015738-31
• Status: Completed
• Phase: Phase 2
• First received: November 6, 2009
• Last updated: August 20, 2015
• Start date: November 2009
• Est. completion date: August 2012

Study information

• Verified date: August 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• YM155
intravenous infusion
• Docetaxel
intravenous infusion

Locations

Country	Name	City	State
Canada	London Regional Cancer Centre	London	Ontario
United States	Univ. of Michigan Health System	Ann Arbor	Michigan
United States	Univ. of Michigan Health System	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	St. Lukes Hospital Cancer Center	Bethlehem	Pennsylvania
United States	MD Anderson Cancer Center	Houston	Texas
United States	The Angeles Clinic and Research	Los Angeles	California
United States	UCLA	Los Angeles	California
United States	University of South Alabama	Mobile	Alabama
United States	University of South Alabama	Mobile	Alabama
United States	Redwood Regional Medical Group	Sebastopol	California
United States	H. Lee Moffitt Cancer Center	Tampa	Florida
United States	Arizona Clinical Research Center	Tuscon	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month Progression-free survival		After the last non-progressing subject completes 6 months or discontinues the treatment	No
Secondary	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	No
Secondary	1 year survival		After the last non-progressing subject completes 6 months or discontinues the treatment	No
Secondary	Overall survival		2 years after the last subject discontinues treatment	No
Secondary	Duration of response		After the last non-progressing subject completes 6 months or discontinues the treatment	No
Secondary	Clinical benefit rate		After the last non-progressing subject completes 6 months or discontinues the treatment	No
Secondary	Time to response		After the last non-progressing subject completes 6 months or discontinues the treatment	No
Secondary	Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)		Monthly	No

External Links

•   Link to results on JAPIC