Last updated: 11/04/2018 08:33:21

Ispinesib In Combination With Carboplatin In Patients With Solid Tumors

GSK study ID
KSP10014
See study documents
Clinicaltrials.gov ID
NCT00136578
EudraCT ID
2004-002248-87
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: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Tolerability of Ispinesib in Combination with Carboplatin on an Every 21-Day Schedule in Subjects with Advanced Solid Tumors.
Trial description: The purpose of this study is to determine the dose regimen of Ispinesib in combination with carboplatin in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion and carboplatin is dosed by 30 minute intravenous infusion every 3 weeks (on the same day). A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with Ispinesib. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Safety and tolerability endpoints will consist of the valuation of adverse events (AEs),vital signs and laboratory values. A dose regimen where = 1 of 6 (or =17%) subjects experience a dose-limiting toxicity.

Timeframe: Up to Day 154

Secondary outcomes:

Antitumor activity will be assessed every 2 cycles and will be recorded as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).

Timeframe: Up to 140

Interventions:
  • Drug: SB-715992
  • Drug: carboplatin
    • Enrollment:
    30
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Solid Tumours
    Product
    ispinesib
    Collaborators
    Not applicable
    Study date(s)
    October 2004 to October 2006
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy.
    • ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2. Exclusion criteria:
    • Females who are pregnant or nursing.
    • Pre-existing hemolytic anemia.
    • Pre-existing peripheral neuropathy greater than or equal grade 2. Greater than or equal to 4 prior chemotherapy regimens including neoadjuvant/adjuvant chemotherapy, except breast cancer subjects who may have received more than 4 prior chemotherapy regimens.
    • Absolute neutrophil count less than 1,500/mm3.
    • Platelets less than 100,000/mm3.
    • Hemoglobin less than 9 g/dL.
    • Total bilirubin greater than1.5 mg/dL.
    • AST/ALT greater than 2.5 X upper limit of normal.
    • Creatinine clearance less than or equal to 50 mL/min (calculated by the Cockcroft Gault Formula).
    • Known contra-indications to the use of carboplatin, cisplatin, or other platinum-containing compounds.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Newcastle Upon Tyne, Northumberland, United Kingdom, NE4 6BE
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37203
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-25-10

    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

    Participate in clinical trial
    Additional information
    Results for study KSP10014 can be found on the GSK Clinical Study Register.
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