Clinical trial · Interventional
A Study of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
A Phase II, Multicenter, Open-Label Study Of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
NCT01009775CI-TRIAL-00019043completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| YM155 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- YM155 plus docetaxel
- interventionNames
- Drug: YM155
- Drug: Docetaxel
Primary outcomes (1)
- measure
- 6-month Progression-free survival
- timeFrame
- After the last non-progressing subject completes 6 months or discontinues the treatment
Secondary outcomes (7)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 functionsReferences
Publications (0)
Data not yet available
No reference posted for this study.