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

Phase 1

Active, not recruiting

• Conditions: Histologically proven metastatic breast cancer.

• Registration Number: EUCTR2005-003216-30-GB
• Lead Sponsor: Bayer Schering Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-14
• Study Completion: 2009-01-15
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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