Metastatic Breast CancerPhase 2NCT00364195
Tesmilifene in Combination With Docetaxel in the Treatment of Metastatic Breast Cancer
A Phase 2 study testing Tesmilifene (YMB1002) in people with Metastatic Breast Cancer, run by YM BioSciences at 3 sites in Serbia.
Trial summary
This is a Phase II study designed to evaluate whether the co-administration of a fixed dose of tesmilifene and a standard regimen of docetaxel alters the plasma pharmacokinetics of docetaxel. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Tesmilifene (YMB1002)
- How many people
- 33 participants
- Where
- 3 sitesSerbia
- Study dates
- Jun 2006to not given
- Phase
- Phase 2
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with documented histological/cytological proof of metastatic and/or recurrent breast cancer suitable for treatment with docetaxel
- Patients must have documented hormone receptor status (ER/PR) and Her-2 neu status determined either by Immunohistochemistry or FISH, within 21 days of randomisation, if possible, otherwise receptor status from patient history can be used, if determined from earlier biopsy/surgery. Patients may be randomised whilst results of hormone receptor status (ER/PR) and Her-2 neu status are pending from the laboratory.
- Radiological investigations must be conducted within 21 days prior to randomization. Exceptions will be made only for patients who have had NEGATIVE examinations with 35 days prior to randomisation.
- Presence of at least one uni-dimensional measurable lesion. 5. Disease free interval (DFI) less than or equal to 24 months (from the time of initial surgery to randomization date).
- 6. Previous hormone therapy, chemotherapy and radiation therapy allowed as defined in the protocol 7. Patients with an ECOG status of 0, 1 or 2. 8. Have a life expectancy of at least 6 months 9. Patients must be female and aged ≥ 18 years and ≤ 65 years 10. Patients must be willing and able to follow instructions and make all required study visits.
- 11. Patients must be willing and able to give written consent to participate in this study.
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- 12. Patients must have adequate organ and marrow function as defined in the protocol.
- 13. All women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L of BHCG) within 72 hours prior to randomization.
- 14. Patients must have a negative blood tests for HIV and Hepatitis B and C within 4 weeks prior to randomisation.
Who cannot join
- Patients with 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.
- Patients with known brain or meningeal metastases (CT scan not required to rule this out unless there is a clinical suspicion of CNS disease).
- Patients whose only measurable disease is in the bone.
- Patients using 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.
- Patients who have received treatment with any other investigational drug within the preceding 4 weeks.
- Patient who have received hormone treatment for cancer within 6 weeks or 5 half-lives of enrolment (whichever is shorter).
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- Pregnant and breast-feeding females.
- Patients with history of seizure disorder.
- Patients with 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, Celebrex®, Vioxx® ) who can not comply with guidelines or concomitant therapy as outlined in appendix V, i.e.; avoid from midnight before treatment until midnight post treatment. Patients who are required to take low dose aspirin (81 mg) may be allowed to continue taking low dose aspirin.
- Patients on H1 antagonists (e.g., antihistamines, antidepressants or antiemetics) detailed in appendix V who can not comply with guidelines or concomitant therapy as outlined in appendix V, i.e.; avoid from 12 hours before the start of protocol treatment begins until the patient is off protocol treatment.
Trial locations and contacts
3 sites in 1 country.
Serbia3 sites
Clinical Hospital Center Bezanijska Kosa
Belgrade
Institute for Oncology and Radiology of Serbia (IORS)
Belgrade
Institute of Oncology Sremska Kamenica
Kamenitz
About this study
Official title: A Pharmacokinetic Interaction and Safety and Efficacy Phase II, Open Label Study With a Safety Lead-in Evaluating Docetaxel Plus Tesmilifene (YMB1002) in Patients With Metastatic Breast Cancer Suitable for Treatment With Docetaxel
This is a Phase II study designed to evaluate whether the co-administration of a fixed dose of tesmilifene and a standard regimen of docetaxel alters the plasma pharmacokinetics of docetaxel. This study will also assess the safety and efficacy of the tesmilifene/docetaxel combination in metastatic breast cancer patients.
Read the detailed description
Primary Objective:
- To evaluate whether the co-administration of a fixed dose of tesmilifene (5.3 mg/kg) with a standard dose of docetaxel (100 mg/m2) alters the plasma pharmacokinetics of docetaxel compared to the pharmacokinetics of docetaxel when given alone.
Secondary Objectives:
- To correlate plasma tesmilifene levels during and following the infusion with the acute tesmilifene-related adverse events observed during and after the infusion.
- To collect safety information for tesmilifene when administered in combination with docetaxel.
- To evaluate response rate, duration of response and overall survival in metastatic breast cancer patients receiving docetaxel plus tesmilifene.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Tesmilifene (YMB1002)
- Keywords
- Metastatic breast cancer, Tesmilifene, DPPE
- 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 (YMB1002)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate whether the co-administration of a fixed dose of tesmilifene (5.3 mg/kg) with a standard dose of docetaxel (100 mg/m2) alters the plasma pharmacokinetics of docetaxel compared to the pharmacokinetics of docetaxel when given alone.
Secondary outcomes (3)
To correlate plasma tesmilifene levels during and following the infusion with the acute tesmilifene-related adverse events observed during and after the infusion.
To collect safety information for tesmilifene when administered in combination with docetaxel.
To evaluate response rate, duration of response and overall survival in metastatic breast cancer patients receiving docetaxel plus tesmilifene.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YM BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364195
- Sponsor's protocol ID
- YMB1002 203
- Status last verified
- Jan 2009
- First submitted
- 14 Aug 2006
- Last updated
- 9 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Interaction and Safety and Efficacy Phase II, Open Label Study With a Safety Lead-in Evaluating Docetaxel Plus Tesmilifene (YMB1002) in Patients With Metastatic Breast Cancer Suitable for Treatment With Docetaxel
- ClinicalTrials.gov ID
- NCT00364195
- Acronym / sponsor ID
- YMB1002 203
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic breast cancer, Tesmilifene, DPPE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- YM BioSciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- First posted
- 15 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 II study designed to evaluate whether the co-administration of a fixed dose of tesmilifene and a standard regimen of docetaxel alters the plasma pharmacokinetics of docetaxel. This study will also assess the safety and efficacy of the tesmilifene/docetaxel combination in metastatic breast cancer patients.
Detailed description
Primary Objective:
- To evaluate whether the co-administration of a fixed dose of tesmilifene (5.3 mg/kg) with a standard dose of docetaxel (100 mg/m2) alters the plasma pharmacokinetics of docetaxel compared to the pharmacokinetics of docetaxel when given alone.
Secondary Objectives:
- To correlate plasma tesmilifene levels during and following the infusion with the acute tesmilifene-related adverse events observed during and after the infusion.
- To collect safety information for tesmilifene when administered in combination with docetaxel.
- To evaluate response rate, duration of response and overall survival in metastatic breast cancer patients receiving docetaxel plus tesmilifene.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with documented histological/cytological proof of metastatic and/or recurrent breast cancer suitable for treatment with docetaxel
- Patients must have documented hormone receptor status (ER/PR) and Her-2 neu status determined either by Immunohistochemistry or FISH, within 21 days of randomisation, if possible, otherwise receptor status from patient history can be used, if determined from earlier biopsy/surgery. Patients may be randomised whilst results of hormone receptor status (ER/PR) and Her-2 neu status are pending from the laboratory.
- Radiological investigations must be conducted within 21 days prior to randomization. Exceptions will be made only for patients who have had NEGATIVE examinations with 35 days prior to randomisation.
- Presence of at least one uni-dimensional measurable lesion. 5. Disease free interval (DFI) less than or equal to 24 months (from the time of initial surgery to randomization date).
- 6. Previous hormone therapy, chemotherapy and radiation therapy allowed as defined in the protocol 7. Patients with an ECOG status of 0, 1 or 2. 8. Have a life expectancy of at least 6 months 9. Patients must be female and aged ≥ 18 years and ≤ 65 years 10. Patients must be willing and able to follow instructions and make all required study visits.
Key exclusion criteria (12 listed)
- Patients with 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.
- Patients with known brain or meningeal metastases (CT scan not required to rule this out unless there is a clinical suspicion of CNS disease).
- Patients whose only measurable disease is in the bone.
- Patients using 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.
- Patients who have received treatment with any other investigational drug within the preceding 4 weeks.
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 (YMB1002) | Drug | – |
Primary outcome
To evaluate whether the co-administration of a fixed dose of tesmilifene (5.3 mg/kg) with a standard dose of docetaxel (100 mg/m2) alters the plasma pharmacokinetics of docetaxel compared to the pharmacokinetics of docetaxel when given alone.
3 secondary outcomes
To correlate plasma tesmilifene levels during and following the infusion with the acute tesmilifene-related adverse events observed during and after the infusion.
To collect safety information for tesmilifene when administered in combination with docetaxel.
To evaluate response rate, duration of response and overall survival in metastatic breast cancer patients receiving docetaxel plus tesmilifene.
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 9 Jan 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tesmilifene (YMB1002) in people with Metastatic Breast Cancer, run by YM BioSciences at 3 sites in Serbia.
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 9 inclusion and 12 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 9 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Serbia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To evaluate whether the co-administration of a fixed dose of tesmilifene (5.3 mg/kg) with a standard dose of docetaxel (100 mg/m2) alters the plasma pharmacokinetics of docetaxel compared to the pharmacokinetics of docetaxel when given alone.. 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 9 Jan 2009.