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
Study complete
Study complete
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
    Primary completion date:
    2006-25-08
    Observational study model:
    Not applicable
    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
    • Inclusion Criteria:
    • Stage IIIB or Stage IV breast cancer
    Inclusion and exclusion criteria
    Inclusion 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
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, W12 0NN
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46202
    Status
    Recruiting
    Contact us
    Location
    GSK Investigational Site
    Newcastle Upon Tyne, Northumberland, United Kingdom, NE4 6BE
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bandar Tun Razak, Cheras, Malaysia, 56000
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chapel Hill, North Carolina, United States, 27599
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Singapore, Singapore, 119074
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 12 Results

    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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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