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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00722293 |
This is an open-label, four-arm, Phase I, dose escalation study to evaluate the safety and tolerability and to determine the optimal tolerated regimen(OTR) of pazopanib in combination with epirubicin or doxorubicin in patients with advanced solid tumors. Patients will be enrolled in cohorts of 3 to receive escalating doses of pazopanib and epirubicin or doxorubicin. Dose escalation schemas for each study arm are described in the protocol. For each arm, the OTR will be defined as the highest dose combination of the agents where no more than one out of six patients experiences a dose-limiting toxicity. Six to twelve additional patients in each arm will be studied with the OTR to evaluate toxicity and pharmacokinetics. This will allow an assessment of potential drug-drug interactions. Antitumor activity will be assessed using RECIST criteria.
Condition | Intervention | Phase |
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Cancer |
Drug: Doxorubicin Drug: Pazopanib (GW786034) Drug: Epirubicin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase I, Open-Label, Study of the Safety, Pharmacokinetics, and Pharmacodynamics Dose Escalation of Pazopanib in Combination With Epirubicin or Doxorubicin for Advanced Solid Tumors. |
Estimated Enrollment: | 78 |
Study Start Date: | July 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
One of more of the following within the past 6 months:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Italy | |
GSK Investigational Site | Recruiting |
Milan, Italy, 20133 | |
Switzerland | |
GSK Investigational Site | Recruiting |
Lausanne, Switzerland, 1011 | |
GSK Investigational Site | Recruiting |
St Gallen, Switzerland, 9007 | |
GSK Investigational Site | Recruiting |
Bellinzona, Switzerland |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | VEG109603 |
Study First Received: | July 23, 2008 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00722293 History of Changes |
Health Authority: | United States: Institutional Review Board |
Solid tumors pazopanib (GW786034) epirubicin doxorubicin |
anti-angiogenesis pharmacokinetics pharmacodynamics |
Anti-Bacterial Agents Epirubicin Doxorubicin |
Antineoplastic Agents Therapeutic Uses Antibiotics, Antineoplastic |
Epirubicin Pharmacologic Actions Doxorubicin |