Trials Sponsors Conditions Drugs Pricing

Conditions

Breast Cancer Leukemia, Myeloid, Chronic

Outcome Measures

Primary Outcomes (1)

Blood samples
5 weeks

Secondary Outcomes (1)

Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests.
5 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: Bosutinib

Interventions

BosutinibDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Men or women of nonchildbearing potential (WONCBP) aged 18 to 65 years inclusive at screening.
WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for more than 1 year (with follicle-stimulating hormone \[FSH\] level greater than or equal to 8 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue using it for 12 weeks after test article administration.

Sponsors & Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer
Industrylead

Study Sites (1)

Warsaw, 02-507, Poland

MeSH Terms

Conditions

Breast NeoplasmsLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

bosutinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeMyeloproliferative DisordersBone Marrow DiseasesHematologic Diseases

Study Officials

Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
STUDY DIRECTOR

Enrollment

27 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 23, 2008

First Posted

September 25, 2008

Study Start

October 2008

Date type not reported

This date has not been verified as actual or estimated.

Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations