Tesmilifene in Combination With Docetaxel in the Treatment of Metastatic Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00364195
• Date of registration: 14/08/2006
• Prospective Registration: No
• Primary sponsor: YM BioSciences
• Public title: Tesmilifene in Combination With Docetaxel in the Treatment of Metastatic Breast Cancer
• Scientific 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
• Date of first enrolment: June 2006
• Target sample size: 33
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00364195
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Former Serbia and Montenegro, Serbia, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients with documented histological/cytological proof of metastatic and/or
recurrent breast cancer suitable for treatment with docetaxel

2. 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.

3. 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.

4. 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.

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.

Exclusion Criteria:

1. 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.

2. Patients with known brain or meningeal metastases (CT scan not required to rule this
out unless there is a clinical suspicion of CNS disease).

3. Patients whose only measurable disease is in the bone.

4. 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.

5. Patients who have received treatment with any other investigational drug within the
preceding 4 weeks.

6. Patient who have received hormone treatment for cancer within 6 weeks or 5 half-lives
of enrolment (whichever is shorter).

7. Pregnant and breast-feeding females.

8. Patients with history of seizure disorder.

9. 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.

10. Known allergy or hypersensitivity to test article ingredients.

11. 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.

12. 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Metastatic Breast Cancer

Intervention(s)

Drug: Tesmilifene (YMB1002)

Primary Outcome(s)

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 Outcome(s)

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.

To correlate plasma tesmilifene levels during and following the infusion with the acute tesmilifene-related adverse events observed during and after the infusion.

Secondary ID(s)

YMB1002 203

Source(s) of Monetary Support

Please refer to primary and secondary sponsors