NCT00089973

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2004

Geographic Reach
5 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2006

Completed
11.5 years until next milestone

Results Posted

Study results publicly available

February 26, 2018

Completed
Last Updated

February 26, 2018

Status Verified

August 1, 2017

Enrollment Period

2.2 years

First QC Date

August 18, 2004

Results QC Date

April 10, 2017

Last Update Submit

August 18, 2017

Conditions

Neoplasms, Breast

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Overall Response Rate (ORR) Following Administration of Ispinesib

    Overall tumor response rate, was defined as the percentage of participants achieving either a complete response (CR) or partial response (PR), stable disease (SD), or progressive disease (PD). It was assessed by Computer tomography (CT) or Magnetic Resonance Imaging (MRI) scan. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. The target lesions (TLs): CR, Disappearance of all TLs; PR where at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as reference the baseline sum LD; PD : At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

    After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months

Secondary Outcomes (9)

  • Median Time to Response

    After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months

  • Duration of Response

    After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months

  • Median Time-to-progression After Administration of Inspinesib

    After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months

  • Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

    From first dose of study drug (Day 1) to 30 days after the last dose (up to 26 months)

  • Number of Participants With Clinical Concern Values for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Temperature and Heart Rate

    After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months

  • +4 more secondary outcomes

Study Arms (1)

SB-715992

EXPERIMENTAL

Females with advanced or metastatic breast cancer were administered Ispinesib

Drug: Ispinesib

Interventions

IspinesibDRUG

Given intravenously at a dose of 18 milligram (mg)/ meter square (m\^2).

SB-715992

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

GSK Investigational Site

Jacksonville, Florida, 32224, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46202, United States

Location

GSK Investigational Site

Chapel Hill, North Carolina, 27599, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

GSK Investigational Site

Brussels, 1000, Belgium

Location

GSK Investigational Site

Bandar Tun Razak, Cheras, 56000, Malaysia

Location

GSK Investigational Site

Bandar Tun Razak, Cheras, 59100, Malaysia

Location

GSK Investigational Site

Singapore, 119074, Singapore

Location

GSK Investigational Site

Singapore, 169610, Singapore

Location

GSK Investigational Site

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

GSK Investigational Site

Manchester, Lancashire, M20 4BX, United Kingdom

Location

GSK Investigational Site

Newcastle upon Tyne, Northumberland, NE4 6BE, United Kingdom

Location

GSK Investigational Site

London, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ispinesib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2004

First Posted

August 20, 2004

Study Start

June 30, 2004

Primary Completion

August 25, 2006

Study Completion

August 25, 2006

Last Updated

February 26, 2018

Results First Posted

February 26, 2018

Record last verified: 2017-08

Locations

US(4)BE(1)SG(2)GB(4)MY(2)