A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00281541

Enrollment

Registered

2006-01-25

Start date

2005-11-30

Completion date

2007-06-30

Last updated

2012-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

Treatment Efficacy, Treatment Effectiveness, Disease Management, Treatment, Safety, Malignant Melanoma

Brief summary

A study with YM155 for the treatment of unresectable stage III or metastatic stage IV melanoma.

Detailed description

A phase II, multicenter, open-label study in subjects with unresectable Stage III or metastatic (Stage IV) Melanoma to evaluate the efficacy and safety of YM155

Interventions

DRUGYM155

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically or cytologically confirmed unresectable stage III or IV malignant melanoma * Life expectancy \>12 weeks

Exclusion criteria

* History of other malignancy in the last 5 years * Major surgery within the past 21 days

Design outcomes

Primary

Measure	Time frame
Tumor response rate	6 cycles

Secondary

Measure	Time frame
Duration of response	6 cycles

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026