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A Clinical Pharmacological Study to Assess the Distribution, Metabolism, and Elimination of YM155 After i.v. Infusion in Patients With Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Clinical Pharmacological Study to Assess the Distribution, Metabolism, and Elimination of YM155 After i.v. Infusion in Patients With Advanced Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

To evaluate the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of YM155 after a 3-hour infusion

Outcome Time Frame:

Day -1 up to and including Day of discharge (Day 11)

Safety Issue:

No

Principal Investigator

Use Central Contact

Investigator Role:

Study Chair

Investigator Affiliation:

Astellas Pharma Europe BV

Authority:

Hungary: National Institute of Pharmacy

Study ID:

155-CL-005

NCT ID:

NCT01023386

Start Date:

November 2009

Completion Date:

March 2010

Related Keywords:

  • Cancer
  • YM155
  • Mass-balance
  • Phase I
  • Pharmacokinetics

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