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

• Register: EUCTR
• Last refreshed on: 4 April 2022
• Main ID: EUCTR2009-015738-31-FR
• Date of registration: 16/10/2009
• Prospective Registration: Yes
• Primary sponsor: Astellas Pharma Global Development, Inc. (APGD)
• Public title: A Phase II, Multicenter, Open-Label Study Of YM155 Plus Docetaxel in Subjects with Stage III (Unresectable) or Stage IV Melanoma
• Scientific title: A Phase II, Multicenter, Open-Label Study Of YM155 Plus Docetaxel in Subjects with Stage III (Unresectable) or Stage IV Melanoma
• Date of first enrolment: 15/12/2009
• Target sample size: 72
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015738-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion criteria:
A subject is eligible for the study if all of the following apply:
1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved
written Informed Consent and privacy language as per national regulations (e.g.,
HIPAA Authorization for U.S. sites) must be obtained from the subject or legally
authorized representative prior to any study-related procedures (including
withdrawal of prohibited medication, if applicable).

2. Male or female subjects aged 18 years or older at the Baseline Visit.

3. Histologically or cytologically confirmed Stage III (unresectable) or Stage IV
melanoma.

4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the
Baseline Visit.

5. No prior systemic treatment for advanced melanoma (Stage III or Stage IV).
Treatment with a kinase inhibitor, biologic therapy, vaccine or investigational
treatment for unknown primary melanoma is allowed if administered in the
adjuvant setting > 4 weeks prior to the Baseline Visit. Treatment with an
immunotherapy is allowed if administered > 6 weeks prior to the Baseline Visit.

6. Completion of palliative radiation treatment if administered > 4 weeks prior to the
Baseline Visit.

7. At least one measurable target lesion according to RECIST (Version 1.1).
o If the lesion received prior radiation, there must be evidence of disease
progression since last radiated.

8. Subjects with a previous history of non-melanoma malignancy are eligible for this
study only if the subject meets the following criteria for a cancer survivor:
o The subject has undergone potentially curative therapy for all prior
malignancies including basal cell or squamous cell carcinoma of the skin or
carcinoma-in-situ of the cervix.
o The subject has been considered disease free for at least 5 years.

9. Life expectancy > 12 weeks at the Baseline Visit.

10. If the subject is female, she must be non-pregnant and non-lactating. Each site
will administer a pregnancy test to any female of childbearing potential during
the Screening Period and at the Baseline Visit. Only females with negative
pregnancy test results will be eligible. All sexually active males and females of
childbearing potential must agree to use an adequate method of contraception
throughout the study period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
A subject will be excluded from participation if any of the following apply:
1. Major surgery within 21 days of the Baseline Visit.

2. Presence of brain metastases.

3. Previously treated with YM155.

4. Primary ocular, choroidal or mucosal melanoma.

5. Neuropathy > Grade 2 at Baseline Visit.

6. Inadequate marrow, hepatic and/or renal function at the Baseline Visit defined as:
o Serum creatinine > 1.5 x upper limit of normal (ULN) or calculated serum
creatinine clearance < 60 mL/min.
o ANC < 1500/mm3.
o Platelet < 100,000/mm3.
o Alanine transaminase (ALT) and Aspartate transaminase (AST) > 1.5 x ULN
concomitant with alkaline phosphatase > 2.5 x ULN.
o Bilirubin > ULN.

7. The subject has significant and/or uncontrolled cardiac, renal, hepatic or other systemic disorders, deep tissue infections or significant psychological conditions at Baseline Visit that in the Investigator’s judgment would jeopardize subject enrollment or compliance with the study procedures.

8. Hypersensitivity to docetaxel or polysorbate 80.

9. 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).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Stage III (Unresectable) or Stage IV Melanoma.
MedDRA version: 12.0 Level: LLT Classification code 10025670 Term: Malignant melanoma stage III
MedDRA version: 12.0 Level: LLT Classification code 10025671 Term: Malignant melanoma stage IV

Intervention(s)

Product Name: YM155
Product Code: YM155
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 781661-94-7
Current Sponsor code: YM155
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: Taxotere
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DOCETAXEL
CAS Number: 114977-28-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Secondary Objective: To evaluate the following:
• Objective Response Rate (ORR).
• 1-year Survival.
• Overall Survival (OS).
• Duration of Response (DOR).
• Clinical Benefit Rate (CBR).
• Time to Response (TTR).
• Safety and tolerability of YM155 given in combination with docetaxel.

Main Objective: To evaluate 6-month Progression Free Survival (PFS).

Primary end point(s): The primary endpoint for the study is progression free survival (PFS). The 6-month PFS is defined as the probability that a patient survives without objective tumor progression at 6 months (24 weeks) following the first dose of study regimen. Objective tumor progression is assessed by the independent radiological review.

Secondary ID(s)

155-CL-034

Ethics review

Status: Approved
Approval date: 15/12/2009
Contact:

Results

• Results available: Yes
• Date Posted: 15/09/2016
• Date Completed: 14/08/2012
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-015738-31/results