Last updated: 11/04/2018 08:15:38

Topotecan Pharmacokinetic Characterization Study

GSK study ID
HYT104152
See study documents
Clinicaltrials.gov ID
NCT00361803
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 Study to Characterize the Pharmacokinetics of 4 mg/m2 Weekly Intravenous Topotecan in Patients with Cancer
Trial description: A multi-center, open label, single dose Phase I pharmacokinetic (PK) characterization of weekly IV (intravenous) topotecan given at 4mg/m2. 15 patients will be evaluated.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

CL and Vss of total topotecan

Timeframe: Predose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.5, 4.5, 6.5, 8.5, 12, and 24 hours after the start of infusion on Day 1

Secondary outcomes:

Cmax tmax t½ AUC(0-t) AUC(0-8) of total topotecan. Safety and tolerability will also be evaluated.

Timeframe: Up to 77 days

Interventions:
  • Drug: topotecan
    • Enrollment:
    15
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Kurtis, KK, Jewell RC, Hartney JT, Griffin, PP, et al. Phase I study to characterize pharmacokinetics (PK) of topotecan (T) at 4 mg/m2 administered weekly as a 30-minute IV infusion. J Clin Oncol 26: 2008 (May 20 suppl; abstr 13551).
    Medical condition
    Cancer
    Product
    topotecan
    Collaborators
    Not applicable
    Study date(s)
    September 2006 to August 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Written informed consent
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Written informed consent
    • Performance status of 0, 1, or 2 on the Eastern Co-operative Oncology Group (ECOG) Scale
    • Predicted life expectancy of at least 3 months
    • Subjects with histologically or cytologically confirmed advanced solid tumors who have failed conventional therapy for their tumor type or have a tumor type for which no standard effective therapy exists; OR Patients for whom single-agent topotecan therapy is suitable
    • At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery
    • Must be free of post-treatment side effects (with the exception of alopecia)
    • No concurrent chemotherapy, biologic therapy or radiotherapy is allowed
    • Hemoglobin = 9.0 g/dL
    • WBC = 3,500/mm3 [= 3.5 x 109/L]
    • Neutrophils = 1,500/mm3 [= 1.5 x 109/L]
    • Platelets = 100,000/mm3 [= 100.0 x 109/L]
    • Calculated creatinine clearance=60 mL/min using the Cockcroft-Gault formula
    • Serum bilirubin < 2.0 mg/dL (34 µmol/L) AST, SGPT/ALT and alkaline phosphatase < 2 times the upper limit of normal if liver metastases cannot be visualized by abdominal computed tomography (CT) or magnetic resonance imaging (MRI scan)
    • If liver metastases are present, subjects with < 5 times the upper limit of normal are eligible to participate Exclusion criteria:
    • Women who are pregnant or lactating
    • Women subjects of childbearing potential who refuse to abstain from sexual intercourse or practice adequate contraception. Childbearing potential is defined as women who are not surgically sterilized (i.e. have not had a hysterectomy, bilateral oophorectomy [ovariectomy], or bilateral tubal ligation) or post-menopausal (i.e., documented absence of menses for one year prior to entry into the study).
    • Men unwilling to abstain from sex or use effective contraception during the study and for 3 months following completion of topotecan treatment
    • Subjects with uncontrolled emesis, regardless of etiology
    • Active infection
    • Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk
    • Treatment with another investigational drug within 30 days or five half-lives prior to entry into the study (whichever is longer)
    • History of allergic reactions to compounds chemically related to topotecan.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Scottsdale, Arizona, United States, 85259
    Status
    Terminated/Withdrawn
    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
    2007-09-08

    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

    Participate in clinical trial
    Additional information
    Results for study HYT104152 can be found on the GSK Clinical Study Register.
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