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Trial record 1 of 1 for:    NCT00732420
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Open-label Study of Topotecan and Pazopanib in Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00732420
First received: August 11, 2008
Last updated: July 30, 2013
Last verified: July 2013

August 11, 2008
July 30, 2013
September 2008
June 2013   (final data collection date for primary outcome measure)
First course tolerability with rising dose of topotecan to determine the maximum tolerated dose of topotecan when given with pazopanib daily. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
First course tolerability with rising dose of topotecan to determine the maximum tolerated dose of topotecan when given with 400mg pazopanib daily.
Complete list of historical versions of study NCT00732420 on ClinicalTrials.gov Archive Site
Indications of efficacy through tumour shrinkage. Specific biomarker analysis. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Indications of efficacy through tumour shrinkage. Specific biomarker analysis.
Not Provided
Not Provided
 
Open-label Study of Topotecan and Pazopanib in Advanced Solid Tumors
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

To determined what dose of topotecan can be safely given with daily pazopanib.

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

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Solid Tumours
  • Drug: topotecan
    Topoisomerase I inhibition.
  • Drug: pazopanib
    Tyrosine kinase inhibitor
  • Experimental: Treatment Arm A
    Daily oral pazopanib in combination with weekly oral topotecan. Initially rising dose to determine the maximum tolerated dose: finally an expanded cohort treated at the maximum tolerated dose.
    Interventions:
    • Drug: topotecan
    • Drug: pazopanib
  • Experimental: Treatment Arm B
    Daily oral pazopanib in combination with oral topotecan given for 5 consecutive days every 21 days. Initially rising dose to determine the maximum tolerated dose; finally an additional cohort of patients treated at the maximum tolerated dose.
    Interventions:
    • Drug: topotecan
    • Drug: pazopanib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Netherlands
 
NCT00732420
HYT109091
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP