Metastatic/Recurrent Breast CancerPhase 1NCT00364754
Pharmacokinetic Study of Tesmilifene (YMB1002) Plus Epirubicin and Cyclophosphamide in Metastatic Breast Cancer
A Phase 1 study testing Tesmilifene (YMB 1002) in people with Metastatic/Recurrent Breast Cancer, run by YM BioSciences at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Metastatic/Recurrent Breast Cancer
- What is being tested?
- Tesmilifene (YMB 1002)
- How many people
- 28 participants
- Where
- 10 sitesin 3 countries
- Study dates
- May 2004to Jan 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- 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.
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- 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.
- ECOG status of 0, 1 or 2.
- Female, aged 18 to 55 years.
- Life expectancy of at least 6 months.
- Patients must be willing and able to follow instructions and make all required study visits.
- Patients must be willing and able to give written consent to participate in this study.
- Disease free interval less than or equal to 36 months.
- Normal organ and marrow function
- 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.
- Negative blood tests for HIV and Hepatitis B and C within 4 weeks prior to randomisation.
Who cannot join
- 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.
- Known brain or meningeal metastases
- 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.
- Treatment with any other investigational drug within the preceding four weeks.
- Pregnant and breast-feeding females.
- History of seizure disorder.
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- 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.
- 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.
- Known allergy or hypersensitivity to test article ingredients.
- 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.
- Patients on H1 antagonists as detailed in the protocol who can not comply with guidelines or concomitant therapy
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Russia6 sites
Chelyabinsk Regional Oncology Dispensary
Chelyabinsk
Blokhin Cancer Research Center
Moscow
Central Clinical Hospital named after Semashko
Moscow
Scientific Research Institute of Oncology named after Petrov
Saint Petersburg
St. Petersburg City Oncology Center
Saint Petersburg
Regional Oncology Dispensary
Yaroslavl
Ukraine3 sites
Dnipropetrovsk Municipal Clinical Hospital No.4
Dnipropetrovsk
Kyiv Municipal Oncology Hospital
Kyiv
Lviv Oncology Regional Treatment and Diagnostic Centre
Lviv
About this 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
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.
Read the 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.
- Conditions
- Metastatic/Recurrent Breast Cancer
- Being tested
- Tesmilifene (YMB 1002)
- Keywords
- Tesmilifene, DPPE, Breast cancer, Cyclophosphamide, Epirubicin, Pharmacokinetic
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tesmilifene (YMB 1002)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (4)
Adverse experiences will be collected and graded using the NCI Expanded Common Terminology Criteria for Adverse Events version 3.0.
Blood pressure, temperature, pulse and respiration will be tabulated across time and shift tables will be presented.
The tesmilifene concentration, haematology and biochemistry values will be tabulated across time.
Although response is not the endpoint of this trial, patients with measurable disease will be assessed by standard institutional criteria.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2006 (estimated)
- Study startMay 2004
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic/Recurrent Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- YM BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Igor Sherman, PhD, Study director, YM BioSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364754
- Sponsor's protocol ID
- YMB1002 202
- Status last verified
- Apr 2014
- First submitted
- 15 Aug 2006
- Last updated
- 21 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00364754
- Acronym / sponsor ID
- YMB1002 202
- Conditions
- Metastatic/Recurrent Breast Cancer
- Keywords
- Tesmilifene, DPPE, Breast cancer, Cyclophosphamide, Epirubicin, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- YM BioSciencesIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 16 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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.
- Previous therapy:
- ECOG status of 0, 1 or 2.
- Female, aged 18 to 55 years.
- Life expectancy of at least 6 months.
Key exclusion criteria (11 listed)
- 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.
- Known brain or meningeal metastases
- 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.
- Treatment with any other investigational drug within the preceding four weeks.
- Pregnant and breast-feeding females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tesmilifene (YMB 1002) | Drug | – |
Primary outcome
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.
4 secondary outcomes
Adverse experiences will be collected and graded using the NCI Expanded Common Terminology Criteria for Adverse Events version 3.0.
Blood pressure, temperature, pulse and respiration will be tabulated across time and shift tables will be presented.
The tesmilifene concentration, haematology and biochemistry values will be tabulated across time.
Although response is not the endpoint of this trial, patients with measurable disease will be assessed by standard institutional criteria.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor Sherman, PhD study director
YM BioSciences
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tesmilifene (YMB 1002) in people with Metastatic/Recurrent Breast Cancer, run by YM BioSciences at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Russia, Ukraine, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.