Last updated: 11/04/2018 08:33:30

Study Of Ispinesib In Subjects With Breast Cancer

GSK study ID
KSP20001
Clinicaltrials.gov ID
NCT00089973
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Phase II, Open Label Study of Ispinesib in Subjects with Advanced or Metastatic Breast Cancer
Trial description: 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?
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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:

Median time to response

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

Duration of response

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

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

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)

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

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

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

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

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

Interventions:
Drug: Ispinesib
Enrollment:
50
Observational study model:
Not applicable
Primary completion date:
2006-25-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Breast
Product
ispinesib
Collaborators
Not applicable
Study date(s)
June 2004 to August 2006
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Stage IIIB or Stage IV breast cancer
  • Previously received anthracycline and taxane therapy
  • Actively receiving anti-cancer therapy agent(s).
Inclusion and exclusion 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).

Trial location(s)

Location
Status
Contact us
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Location
GSK Investigational Site
London, United Kingdom, W12 0NN
Status
Study Complete
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Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Recruiting
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Location
GSK Investigational Site
Newcastle Upon Tyne, Northumberland, United Kingdom, NE4 6BE
Status
Study Complete
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Location
GSK Investigational Site
Bandar Tun Razak, Cheras, Malaysia, 56000
Status
Study Complete
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Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Status
Study Complete
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Location
GSK Investigational Site
Singapore, Singapore, 119074
Status
Study Complete
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Location
GSK Investigational Site
Southampton, Hampshire, United Kingdom, SO16 6YD
Status
Study Complete
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Location
GSK Investigational Site
Jacksonville, Florida, United States, 32224
Status
Study Complete
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Location
GSK Investigational Site
Singapore, Singapore, 169610
Status
Study Complete
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Location
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M20 4BX
Status
Will Be Recruiting
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Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Status
Will Be Recruiting
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Location
GSK Investigational Site
Bruxelles, Belgium, 1000
Status
Study Complete
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Study documents

No study documents available.

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2006-25-08
Actual study completion date
2006-25-08

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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