EXPLORATORY EVALUATION OF A SEQUENTIAL ADMINISTRATION OF DOCETAXEL AND SU011248 IN WOMEN WITH ADVANCED BREAST CANCER

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-000224-13-SE
• Date of registration: 27/02/2006
• Prospective Registration: Yes
• Primary sponsor: PFIZER AB
• Public title: EXPLORATORY EVALUATION OF A SEQUENTIAL ADMINISTRATION OF DOCETAXEL AND SU011248 IN WOMEN WITH ADVANCED BREAST CANCER
• Scientific title: EXPLORATORY EVALUATION OF A SEQUENTIAL ADMINISTRATION OF DOCETAXEL AND SU011248 IN WOMEN WITH ADVANCED BREAST CANCER
• Date of first enrolment: 10/05/2006
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000224-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: Randomised: Open: yes Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Italy, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
1. Histologically or cytologically proven diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease. Locally recurrent disease must not be amenable to resection or radiation therapy with curative intent.
2. Her-2 negative breast cancer (ie, FISH negative or immunohistochemistry 0 or +1).
3. Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) is preferable with the presence of at least 1 measurable lesion not previously irradiated.
4. Must have received prior adjuvant anthracycline-based therapy. If adjuvant therapy included a taxane, relapse must have occurred ?12 months since completion of chemotherapy. Hormonal therapy concurrent or sequential to adjuvant chemotherapy is allowed as well as hormonal therapy for locally advanced or metastatic disease. Hormonal therapy is to be discontinued ?3 weeks prior to start of study treatment.
5. May have received prior radiation therapy. A measurable lesion that has been previously irradiated will not be considered to be a target lesion and will be evaluated only when it increases in size. Radiotherapy is to be completed ?3 weeks prior to start of study treatment.
6. Female, 18 years of age or older.
7. ECOG performance status 0 or 1.
8. Resolution of all acute toxic effects of prior therapy or surgical procedures to grade ?1 (except alopecia).
9. Adequate organ function as defined by the following criteria:
• Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ?1.5 x upper limit of normal (ULN), or AST and ALT ?2.5 x ULN if liver function abnormalities are due to underlying malignancy
• Alkaline phosphatase (ALP) ?2.5 x ULN
• Total serum bilirubin < ULN
• Serum albumin ?3.0 g/dL
• Absolute neutrophil count (ANC) ?1500/?L
• Platelets ?100,000/?L
• Hemoglobin ?9.0 g/dL
• Serum creatinine ?1.5 x ULN
• Left ventricular ejection fraction (LVEF) ?50% as measured by either multigated acquisition (MUGA) scan or echocardiogram (ECHO)
10. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
11. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Histology of inflammatory carcinoma.
2. Prior treatment with chemotherapy in the metastatic disease setting.
3. Prior treatment on a SU011248 clinical trial.
4. Prior treatment with any tyrosine kinase inhibitors, VEGF inhibitors, or other angiogenic inhibitors.
5. History of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80.
6. AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN
7. Major surgery, radiation therapy, or systemic therapy within 3 weeks of start of study treatment. At least 1 week should elapse since minor surgical procedures including placement of an access device or fine needle aspiration.
8. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
9. Prior radiation therapy to >25% of the bone marrow (whole pelvis is 25%).
10. Current treatment on another clinical trial.
11. Presence of brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
12. Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell carcinoma or squamous cell skin cancer or in situ carcinoma of the cervix uteri.
13. Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus.
14. Ongoing cardiac dysrhythmias of grade ?2, atrial fibrillation of any grade, or QTc interval >470 msec.
15. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
16. Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
17. Known human immunodeficiency virus infection.
18. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to study entry.
19. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.



Age minimum:
Age maximum:
Gender:
Female:
Male:

Health Condition(s) or Problem(s) studied

Advanced Breast Cancer
MedDRA version: 8.0 Level: PT Classification code 10006187

Intervention(s)

Product Name: sunitinib malate
Product Code: SU011248
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: sunitinib malate
Current Sponsor code: SU011248
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 12,5- 25 -

Product Name: docetaxel
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: docetaxel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20 -80-

Primary Outcome(s)

Primary end point(s): Pharmacokinetic parameters of docetaxel, SU011248 and its active metabolite SU012662

Secondary Objective:
1. To assess the tolerability of the combination of SU011248 given at 37.5 mg/day (Schedule2/1) with docetaxel administered at 75 mg/m2 every 3 weeks in ABC patients who haverelapsed after an anthracycline-based adjuvant regimen.

2. To assess preliminary anti-tumor activity of the combination SU011248/docetaxel

Main Objective: To characterize the pharmacokinetics of docetaxel and SU011248 (and its metabolite,
SU012662) according to the schedule adopted in the trial.

Secondary ID(s)

A6181100