Prospective, multicenter, randomized, parallel-group, open-label phase II study to investigate the efficacy, safety and tolerability of 2 doses of ZK 219477 (16 and 12 mg/m2 body surface area) in patients with metastatic breast cancer
- Conditions
- Histologically proven metastatic breast cancer.
- Registration Number
- EUCTR2005-003216-30-SI
- Lead Sponsor
- Schering AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 54
1. Females aged >/= 18 years
2. Histologically proven (at diagnosis), metastatic breast cancer
3. At least 1 unidimensionally measurable lesion (suitable for modRECIST evaluation)
4. Performance status: WHO 0-1
5. Progression of disease following a maximum of two previous steps of chemotherapy, including treatments in an adjuvant or neoadjuvant setting
6. No previous taxane or vinca alkaloid treatment
7. No more than 1 non cytotoxic therapy (biologic agents)
8. No radiotherapy, chemotherapy, or immune/biologic therapy within 3 weeks prior to first dose of ZK 219477
9. Adequate recovery from previous surgery, radiation, and chemotherapy
10. Adequate function of major organs and systems
Hematopoietic:
- Hemoglobin >/= 10 g/dL
- WBC >/= 3,000/mm3
- Absolute neutrophil count >/= 1,500/mm3
- Platelet count >/= 100,000/mm3
Hepatic:
- Bilirubin within normal limits
- AST/ALT
Renal:
- Creatinine
Cardiovascular:
- No New York Heart Association (NYHA) class III or IV
heart failure (see Attachment 4)
- No unstable angina pectoris
- No arrhythmia needing continuous treatment
No other uncontrolled concurrent illness
11. Negative pregnancy test at enrollment (females of childbearing potential only)
12. Agreement to use highly effective contraception methods (intra-uterine contraceptive device [IUCD], condoms, oral contraceptives, or other adequate barrier contraception) in females of child-bearing potential
13. In case the patients participate in the optional PET-Scan substudy: Able to tolerate PET imaging
14. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. More than 2 previous chemotherapy regimens (including those given in an adjuvant or neo-adjuvant setting)
2. Peripheral neuropathy
3. Any prior treatment with epothilones
4. Use of any investigational drug within 4 weeks before start of study treatment or inadequate recovery from any toxic effects of such therapy
5. Candidacy for curative resection
6. Brain metastases requiring whole-brain irradiation
7. Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix
8. Active infection
9. Breast-feeding
10. Any conditions that in the opinion of the investigator could hamper the compliance with the study protocol
11. In case the patients participate in the optional PET-Scan substudy: Poorly controlled diabetes defined as fasting glucose levels of >200 mg/dL.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the efficacy of 2 doses of ZK 219477 in patients with metastatic breast cancer in progression following a maximum of 2 previous regimen of chemotherapy. Previous chemotherapy must not include taxanes or vinca alkaloids.;Secondary Objective: To investigate safety and tolerability of 2 doses of ZK 219477.;Primary end point(s): Proportion of patients with either CR or PR as best overall response
- Secondary Outcome Measures
Name Time Method