Prospective, multicenter, randomized, independent-group, open-label phase II study to investigate the efficacy, safety and tolerability of 4 regimes with 3 doses of ZK 219477 (16 and 12 mg/m² body surface area as 3-hour infusion or 22 mg/m² body surface area as 30-minute or 3-hour infusion) in patients with metastatic breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003216-30-DE

Enrollment

120

Registered

2005-10-04

Start date

2005-11-14

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Histologically proven metastatic breast cancer.

Interventions

Product Code: SH Y03757A Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: not available Current Sponsor code: ZK 219477 Concentration unit: mg milligram(s) Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficacy of 4 regimes with 3 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 4 regimes with 3 doses of ZK 219477.;Primary end point(s): Proportion of patients with either CR or PR as best overall response	—

Measure

Time frame

Main Objective: To investigate the efficacy of 4 regimes with 3 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 4 regimes with 3 doses of ZK 219477.;Primary end point(s): Proportion of patients with either CR or PR as best overall response

—

Countries

Germany, Italy, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026