Last updated: 11/04/2018 08:33:01

SB-715992 In Combination With Docetaxel In Patients With Solid Tumors

GSK study ID
KSP10003
Clinicaltrials.gov ID
NCT00169520
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: A Phase I, Open-Label Study of SB-715992 in Combination with Docetaxel in Patients with Advanced Solid Tumors.
Trial description: The purpose of this study is to determine the dose regimen of SB-715992 in combination with docetaxel in patients with solid tumors. SB-715992 and docetaxel were dosed by 1-hour 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 SB-715992. 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: throughout the study

Secondary outcomes:

PK endpoints of SB-715992 and docetaxel pending the conduct of the PK interaction portion. Antitumor activity will be assessed every 2 cycles (PD).

Timeframe: every 2 cycles

Interventions:
  • Drug: docetaxel
  • Drug: SB-715992
    • Enrollment:
    30
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Solid Tumor Cancer
    Product
    ispinesib
    Collaborators
    Not applicable
    Study date(s)
    June 2004 to October 2005
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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.
    • Females who are pregnant or nursing.
    • Pre-existing hemolytic anemia.
    Inclusion and exclusion 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 60 mL/min (calculated by the Cockcroft Gault Formula).
    • Known contraindications to the use of docetaxel or to other drugs formulated with polysorbate 80.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, SW3 6JJ
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Oxford, Oxfordshire, United Kingdom, OX2 6PD
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-21-10

    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

    Additional information
    Not applicable
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