Last updated: 11/04/2018 08:16:58

Open-label Study of Topotecan and Pazopanib in advanced solid tumors

GSK study ID
HYT109091
See study documents
Clinicaltrials.gov ID
NCT00732420
EudraCT ID
2007-007636-25
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 the Safety, Tolerability, and Pharmacokinetics of Two Schedules of Oral Topotecan in combination with Pazopanib in Subjects with Advanced Solid Tumors
Trial description: To determined what dose of topotecan can be safely given with daily pazopanib.
Primary purpose:
Screening
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

First course tolerability with rising dose of topotecan to determine the maximum tolerated dose of topotecan when given with pazopanib daily.

Timeframe: 5 weeks

Secondary outcomes:

Indications of efficacy through tumour shrinkage. Specific biomarker analysis.

Timeframe: 12 weeks

Interventions:
  • Drug: topotecan
  • Drug: pazopanib
    • Enrollment:
    68
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Solid Tumours
    Product
    pazopanib, topotecan
    Collaborators
    Not applicable
    Study date(s)
    September 2008 to June 2013
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion Criteria -
    • signed, written informed consent.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria
    • signed, written informed consent.
    • at least 18 years of age.
    • ECOG performance status 0 or 1.
    • Subjects must have histologically or cytologically confirmed diagnosis of advanced cancer and a solid tumor malignancy that has relapsed or is refractory to standard therapy or for which there is no established therapy.
    • able to swallow and retain oral medications.
    • females are eligible to enter and participate in this study providing adequate established contraception is being practiced. Exclusion Criteria
    • had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
    • received an investigational drug within 30 days or 5 half-lives (whichever is longer).
    • received prior treatment with pazopanib/investigational anti-angiogenic compounds.
    • presence of uncontrolled infection.
    • pregnant or lactating.
    • poorly controlled hypertension (SBP of ? 140 mmHg, or DBP of ? 90 mmHg.
    • Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.-
    • arterial thrombi, myocardial infarction, admission for unstable angina, uncontrolled or symptomatic arrhythmia, cardiac angioplasty, or stenting within the last 6 months.
    • any unresolved bowel obstruction or diarrhea ? Grade 1.
    • received an allogeneic bone marrow transplant.
    • known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or topotecan.
    • any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance with the study.
    • psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
    • clinical history, current alcohol or illicit drug use which, in the judgment of the investigator, would interfere with the subject’s ability to comply with the dosing schedule and protocol-specified evaluations.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Amsterdam, Netherlands, 1066 CX
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    UTRECHT, Netherlands, 3584 CX
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19104
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    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
    2013-12-06

    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 HYT109091 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
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