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A Study Evaluating the Proton Pump Inhibitor Pantoprazole in Combination With Doxorubicin for Advanced Cancer Patients With an Extension Cohort of Metastatic Breast Cancer Patients

2014-08-27 03:12:10 | BioPortfolio

Summary

This is a single-centre, open label, dose finding, phase I study to determine the recommended phase II dose (RP2D) for the combination of doxorubicin and pantoprazole in patients with advanced tumours and no standard treatment options. A minimum of 3 patients will be enrolled per dose level and intra-patient dose escalation is not permitted. Once the RP2D has been identified, six additional patients will be treated at the RP2D to confirm its tolerability. This cohort will include only patients with metastatic breast cancer with no standard treatment options.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Advanced Solid Tumours

Intervention

pantoprazole sodium for injection, doxorubicin hydrochloride injection

Location

Princess Margaret Hospital
Toronto
Ontario
Canada
M5G 2M9

Status

Not yet recruiting

Source

University Health Network, Toronto

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:10-0400

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Adverse reactions that occur initially at the site of injection or infusion. Milder type is confined to a local allergic flare reaction. A more severe reaction is caused by extravasation of VESICANTS from the blood vessel at the site of injection and can cause damage to the surrounding tissue. In tumor flare reaction symptoms involve well beyond the injection site such as an increase in the tumor size and tumor markers levels, bone pain, and HYPERCALCEMIA.

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