An Extension Study Administering YM155 to Subjects Previously Enrolled in Another Protocol Administering YM155

Astellas

Status and phase: Completed; Phase 2

Conditions: Melanoma; Non-Hodgkin's Lymphoma; Prostate Cancer

Treatments: Drug: YM155

Study type: Interventional

Funder types: Industry

Identifiers

NCT00818480

155-CL-101

Details and patient eligibility

About

This protocol is open to subjects previously enrolled in and who had completed a Phase I or Phase II study administering YM155. Subjects who are receiving benefit from treatment with YM155 are eligible after completing the previous study.

Full description

The main objective of the study is to continue to evaluate the safety and efficacy of YM155.

Each subject will be treated at the dose he/she was receiving at the completion of his/her previous phase I or phase II YM155 study.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completed a Phase I or II YM155 study with at least stable disease and continues to meet the criteria as stated in the previous YM155 study that allows for additional treatment with YM155
• Lack of progression based on the most recent radiological imaging, biochemical assessments and/or physical examination
• Negative pregnancy test result (females of child-bearing potential)

Exclusion criteria

• More than 21 days (or 14 days depending on the study of origin) between the time the last infusion of YM155 was stopped in the previous study and the proposed start of the first infusion in this study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

1. YM155

Experimental group

Treatment:

Drug: YM155