MedTrace Logo

Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors

NCT00195260 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2013-02-11

Study results available
· View outcomes & findings →

Summary

To evaluate the safety and tolerability of oral SKI-606 (bosutinib) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population.

Conditions

  • Neoplasms

Interventions

DRUG

bosutinib

Dose levels evaluated 50mg, 100mg, 200mg, 300mg, 400mg, 500mg and 600mg. 500mg was identified as MTD, however due to GI toxicities at that dose, 400mg was selected as the RP2D. Drug was administered as long as tolerable and disease under study did not worsen.

DRUG

bosutinib

400mg QD bosutinib, as long as tolerated and disease under study does not worsen.

DRUG

bosutinib

400mg QD bosutinib, as long as tolerated and disease under study does not worsen.

DRUG

bosutinib

400mg QD bosutinib, as long as tolerated and disease under study does not worsen.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00195260 on ClinicalTrials.gov