A Clinical Pharmacological Study of YM155 After Intravenous Infusion in Patients With Advanced Cancer

Astellas

Status and phase

Completed

Phase 1

Conditions

Cancer

Treatments

Drug: YM155

Study type

Interventional

Funder types

Industry

Identifiers

NCT01023386

155-CL-005

2008-002049-21 (Other Identifier)

Details and patient eligibility

About

This study investigates the pharmacokinetics of YM155, identifies the metabolic profile of YM155 and evaluates the safety and tolerability of YM155 after a 3-hour infusion in patients with advanced cancer

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors or non-Hodgkin's lymphomas for which YM155 has the potential, based on preclinical and/or clinical data, to show efficacy, namely:
- castrate resistant prostate cancer
- non-small cell lung cancer
- metastatic melanoma
- muscle invasive bladder cancer
- follicular lymphoma
- diffuse large B-cell lymphoma
Life expectancy ≥ 3 months; and Performance status (PS) ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale at baseline

Exclusion criteria

Radiotherapy, major surgery, hormonal therapy, and chemotherapy within 4 weeks prior to the first dose of study medication and 6 weeks in the case of mitomycin-C or nitrosourea
Previous therapy with YM155
Patients with renal, hepatic or colorectal cancers
Inadequate bone marrow, renal and/or hepatic function
History of being treated for other malignancy within 5 years except for treated basal or squamous cell carcinoma of the skin
Participation in any clinical study within 4 weeks prior to start of the first dose of study medication
Known brain or leptomeningeal metastases
Active uncontrolled systemic infection at baseline