Clinical trial NCT00089973: Study Of Ispinesib In Subjects With Breast Cancer
Official title: Phase II, Open Label Study of Ispinesib in Subjects With Advanced or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms, Breast
Keywords: breast cancer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2004-08-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to find how breast cancer responds to the investigational drug, Ispinesib. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. In particular, this study will try is to find the answers to the following research questions:

1. Does breast cancer respond to Ispinesib?
2. What are the side effects of Ispinesib?
3. How much Ispinesib is in the blood at specific times after it is taken?


Eligibility criteria: Inclusion Criteria:

* Stage IIIB or Stage IV breast cancer
* Previously received anthracycline and taxane therapy

Exclusion criteria:

* Actively receiving anti-cancer therapy agent(s).

Primary outcomes:
measure: Percentage of Participants With Overall Response Rate (ORR) Following Administration of Ispinesib
timeFrame: After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months
Secondary outcomes:
measure: Median Time to Response
timeFrame: After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months
measure: Duration of Response
timeFrame: After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months
measure: Median Time-to-progression After Administration of Inspinesib
timeFrame: After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months
measure: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: From first dose of study drug (Day 1) to 30 days after the last dose (up to 26 months)
measure: Number of Participants With Clinical Concern Values for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Temperature and Heart Rate
timeFrame: After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months
measure: Number of Participants With Toxicity Shift Grade From Baseline for Hematology Parameters
timeFrame: After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months
measure: Number of Participants With Toxicity Shift Grade From Baseline for Clinical Chemistry Grade Shifts
timeFrame: After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months
measure: Pharmacokinetic (PK) Parameter-Clearance
timeFrame: Pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours up to Cycle 10, up to 26 months
measure: PK Parameter-Volume of Distribution
timeFrame: Pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours up to Cycle 10, up to 26 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Bandar Tun Razak, Cheras
country: Malaysia
facility: GSK Investigational Site
city: Bandar Tun Razak, Cheras
country: Malaysia
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Southampton
country: United Kingdom
facility: GSK Investigational Site
state: Hampshire
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Newcastle Upon Tyne
country: United Kingdom
facility: GSK Investigational Site
state: Northumberland
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: