A Study of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
This study has been completed.
Sponsor:
Astellas Pharma Inc
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
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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
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 |
ClinicalTrials.gov processed this record on May 19, 2013