Expired Study
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Philadelphia, Pennsylvania 19104


Purpose:

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


Study summary:

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


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.


NCT ID:

NCT00732420


Primary Contact:

Study Director
GSK Clinical Trials
GlaxoSmithKline


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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