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A Study of Ispinesib in Metastatic Breast Cancer

NCT00607841 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-05-06

No results posted yet for this study

Summary

The Phase I portion was a dose-escalation study designed to assess safety and tolerability in patients with metastatic breast cancer. Phase II was intended to measure response rate in patients with metastatic breast cancer but did not enroll because the Phase I portion was halted prior to Maximum Tolerated Dose (MTD) determination.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Ispinesib

10 mg/m2 dose as a 1-hour intravenous infusion.

DRUG

Ispinesib

12 mg/m2 dose as a 1-hour intravenous infusion.

DRUG

Ispinesib

14 mg/m2 dose as a 1-hour intravenous infusion.

Sponsors & Collaborators

  • Cytokinetics

    lead INDUSTRY

Principal Investigators

  • Andrew A Wolff, MD, FACC · Cytokinetics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Peru

Study Locations

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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 NCT00607841 on ClinicalTrials.gov