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Sponsored by: |
YM BioSciences |
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Information provided by: | YM BioSciences |
ClinicalTrials.gov Identifier: | NCT00364754 |
This is a Phase I, multi-centre, open-label, cross-over pharmacokinetic study designed to investigate whether the co-administration of a fixed dose of tesmilifene alters the plasma pharmacokinetics of a standard regimen of epirubicin and/or its principle metabolite, epirubicinol and cyclophosphamide.
Condition | Intervention | Phase |
---|---|---|
Metastatic/Recurrent Breast Cancer |
Drug: Tesmilifene (YMB 1002) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | A PHARMACOKINETIC INTERACTION PHASE I, MULTI-CENTRE, OPEN-LABEL, CROSS-OVER Study Evaluating the Effect of Tesmilifene on the Plasma Pharmacokinetics of Epirubicin and Cyclophosphamide in Patients With Metastatic/Recurrent Breast Cancer |
Estimated Enrollment: | 28 |
Study Start Date: | March 2006 |
This is a Phase I, multi-centre, open-label, cross-over pharmacokinetic study designed to investigate whether the co-administration of a fixed dose of tesmilifene alters the plasma pharmacokinetics of a standard regimen of epirubicin and/or it’s principle metabolite, epirubicinol and cyclophosphamide. The plasma pharmacokinetics of epirubicin/epirubicinol and cyclophosphamide when given alone or concurrently with tesmilifene will be examined. Safety information for the tesmilifene/ epirubicin and cyclophosphamide combination and for epirubicin and cyclophosphamide alone in this patient population will also be collected.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Previous therapy:
Exclusion Criteria:
Georgia | |
Pharmina | |
Tbilisi, Georgia | |
Russian Federation | |
Blokhin Cancer Research Center | |
Moscow, Russian Federation | |
Regional Oncology Dispensary | |
Yaroslavl, Russian Federation | |
Chelyabinsk Regional Oncology Dispensary | |
Chelyabinsk, Russian Federation | |
Central Clinical Hospital named after Semashko | |
Moscow, Russian Federation | |
Scientific Research Institute of Oncology named after Petrov | |
St. Petersburg, Russian Federation | |
St. Petersburg City Oncology Center | |
St. Petersburg, Russian Federation | |
Ukraine | |
Dnipropetrovsk Municipal Clinical Hospital No.4 | |
Dnipropetrovsk, Ukraine | |
Lviv Oncology Regional Treatment and Diagnostic Centre | |
Lviv, Ukraine | |
Kyiv Municipal Oncology Hospital | |
Kyiv, Ukraine |
Study Director: | Igor Sherman, PhD | YM BioSciences |
Study ID Numbers: | YMB1002 202 |
Study First Received: | August 15, 2006 |
Last Updated: | August 24, 2006 |
ClinicalTrials.gov Identifier: | NCT00364754 |
Health Authority: | Ukraine: State Pharmacological Center - Ministry of Health; Georgia: Ministry of Health; Russia: Ministry of Health and Social Development of Russian Federation |
Tesmilifene DPPE Breast cancer |
Cyclophosphamide Epirubicin Pharmacokinetic |
Skin Diseases N,N-diethyl-2-((4-phenylmethyl)phenoxy)ethanamine Histamine phosphate Breast Neoplasms Cyclophosphamide |
Epirubicin Breast Diseases Recurrence Histamine |
Neurotransmitter Agents Disease Attributes Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematologic Agents Physiological Effects of Drugs Histamine Agents Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Pathologic Processes Histamine Antagonists Therapeutic Uses Myeloablative Agonists Platelet Aggregation Inhibitors Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |