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

NCT01023386 | Completed Phase 1

• 2 other identifiers: 155-CL-0052008-002049-21
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Keywords

YM155; Mass-balance; Phase I; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (2)

• To identify the metabolic profile of YM155

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

• To evaluate the safety and tolerability of YM155 through vital signs, laboratory analysis, adverse events, physical exams, ECOG performance status and echo-cardiography

  Screening (Day -21 to -2), Day -1 up to and including Day of discharge (Day 11) and end of study visit (7-14 weeks after discharge)

Interventions

YM155 DRUG

I.V.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Budapest, 1122, Hungary

Location

MeSH Terms

Conditions

Neoplasms

Interventions

sepantronium

Study Officials

• Use Central Contact

  Astellas Pharma Europe B.V.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 2, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 13, 2010

Record last verified: 2010-04

Locations

HU (1)