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Pharmacokinetic Study of Tesmilifene (YMB1002) Plus Epirubicin and Cyclophosphamide in Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00364754
Recruitment Status : Completed
First Posted : August 16, 2006
Last Update Posted : April 21, 2014
Information provided by (Responsible Party):
YM BioSciences

Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic/Recurrent Breast Cancer Drug: Tesmilifene (YMB 1002) Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. The distribution of the pharmacokinetic variables will be summarized by treatment. The variables AUC and CMAX expressed as geometric means and ratios of geometric means on the original scale of measurement.

Secondary Outcome Measures :
  1. Adverse experiences will be collected and graded using the NCI Expanded Common Terminology Criteria for Adverse Events version 3.0.
  2. Blood pressure, temperature, pulse and respiration will be tabulated across time and shift tables will be presented.
  3. The tesmilifene concentration, haematology and biochemistry values will be tabulated across time.
  4. Although response is not the endpoint of this trial, patients with measurable disease will be assessed by standard institutional criteria.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with documented histological/cytological proof of metastatic and/or recurrent breast cancer suitable for treatment with epirubicin and cyclophosphamide. Patients with locally advanced and inoperable lesions are also eligible.
  2. Previous therapy:

    • If patients have had hormone-responsive disease, randomization is permitted after 6 weeks off anti-hormonal therapy or 5 half lives (whichever is shorter) unless there is evidence of progressive disease in which case patients could be randomized earlier.
    • No previous exposure to anthracycline/anthracenedione-based chemotherapy.
    • Patients may have received non-anthracycline/anthracenedione based adjuvant chemotherapy, completed a minimum of 4 weeks prior to randomization. Patients must not have had previous chemotherapy for metastatic disease.
    • Immunotherapy and experimental therapy must stop a minimum of 4 weeks prior to randomization.
    • A minimum of four weeks must have elapsed between the end of prior radiotherapy and randomization. Exceptions will be made, however, for palliative radiotherapy which involves no more than 30% of bone marrow.
  3. ECOG status of 0, 1 or 2.
  4. Female, aged 18 to 55 years.
  5. Life expectancy of at least 6 months.
  6. Patients must be willing and able to follow instructions and make all required study visits.
  7. Patients must be willing and able to give written consent to participate in this study.
  8. Disease free interval less than or equal to 36 months.
  9. Normal organ and marrow function
  10. Negative serum or urine pregnancy test within 72 hours prior to randomization and must be on a medically recognized form of birth control that is approved by the investigator.
  11. Negative blood tests for HIV and Hepatitis B and C within 4 weeks prior to randomisation.

Exclusion Criteria:

  1. Previous malignancies, excluding curatively treated basal or squamous cell carcinoma of the skin or in-situ cervical cancer or any other cancer treated more than five years prior to study entry and presumed cured.
  2. Known brain or meningeal metastases
  3. Use of chemotherapeutic agents for any malignancy within 4 weeks prior to study entry or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  4. Treatment with any other investigational drug within the preceding four weeks.
  5. Pregnant and breast-feeding females.
  6. History of seizure disorder.
  7. Clinical evidence of congestive heart failure, recent myocardial infarction within 6 months, uncontrolled arterial hypertension, unstable angina, cardiomyopathy or arterial or ventricular clinically significant arrhythmias even if medically controlled.
  8. Clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, respiratory, neurologic, psychiatric, immunologic, gastrointestinal, haematologic, metabolic or any other condition or laboratory abnormality that, in the opinion of the Investigator or Medical Director of YM BioSciences Inc., makes the patient unsuitable for participation in the study.
  9. Known allergy or hypersensitivity to test article ingredients.
  10. Patients on COX 1 or 2 prostaglandin inhibitors (e.g. ASA, other NSAID's, Celcbrex®, Vioxx® ) who can not comply with guidelines or concomitant therapy.
  11. Patients on H1 antagonists as detailed in the protocol who can not comply with guidelines or concomitant therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00364754

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Tbilisi, Georgia
Russian Federation
Chelyabinsk Regional Oncology Dispensary
Chelyabinsk, Russian Federation
Blokhin Cancer Research Center
Moscow, 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
Regional Oncology Dispensary
Yaroslavl, Russian Federation
Dnipropetrovsk Municipal Clinical Hospital No.4
Dnipropetrovsk, Ukraine
Kyiv Municipal Oncology Hospital
Kyiv, Ukraine
Lviv Oncology Regional Treatment and Diagnostic Centre
Lviv, Ukraine
Sponsors and Collaborators
YM BioSciences
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Study Director: Igor Sherman, PhD YM BioSciences

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Responsible Party: YM BioSciences Identifier: NCT00364754    
Other Study ID Numbers: YMB1002 202
First Posted: August 16, 2006    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: April 2014
Keywords provided by YM BioSciences:
Breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Platelet Aggregation Inhibitors