Clinical trial NCT01009775: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Keywords: Melanoma, Stage III
Melanoma, Stage IV
YM 155
Metastatic Melanoma
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-11-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 6-month Progression-free survival
timeFrame: After the last non-progressing subject completes 6 months or discontinues the treatment
Secondary outcomes:
measure: Objective response rate (proportion of subjects with complete response or partial response)
timeFrame: After the last non-progressing subject completes 6 months or discontinues the treatment
measure: 1 year survival
timeFrame: After the last non-progressing subject completes 6 months or discontinues the treatment
measure: Overall survival
timeFrame: 2 years after the last subject discontinues treatment
measure: Duration of response
timeFrame: After the last non-progressing subject completes 6 months or discontinues the treatment
measure: Clinical benefit rate
timeFrame: After the last non-progressing subject completes 6 months or discontinues the treatment
measure: Time to response
timeFrame: After the last non-progressing subject completes 6 months or discontinues the treatment
measure: Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
timeFrame: Monthly
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Tuscon
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Sebastopol
country: United States
facility: Redwood Regional Medical Group
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Ann Arbor
country: United States
facility: Univ. of Michigan Health System
state: Michigan
city: Ann Arbor
country: United States
facility: Univ. of Michigan Health System
state: Michigan
city: Bethlehem
country: United States
facility: St. Lukes Hospital Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
Study officials:
affiliation: Astellas Pharma Global Development
name: Sr. Medical Director
role: STUDY_DIRECTOR
References: