Overview

Single Dose Escalation Study of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Metastatic Breast Cancer

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
Summary
Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Bivatuzumab mertansine
Maytansine
Criteria
Inclusion Criteria:

1. female patients aged 18 years or older

2. patients with breast cancer positive for CD44v6 in at least 50 % of the tumour cells

3. patients with metastases pretreated with anthracyclines and taxanes (unless
contraindications to taxanes and / or anthracyclines) or not amenable to established
treatments

4. measurable tumour deposits by one or more radiological techniques (MRI, CT)

5. life expectancy of at least 6 months

6. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2

7. patients must have given written informed consent (which must be consistent with
International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local
legislation)

Exclusion Criteria:

1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients
of the trial drugs

2. known secondary malignancy requiring therapy

3. active infectious disease

4. brain metastases requiring therapy

5. neuropathy common toxicity criteria (CTC) grade 2 or above

6. absolute neutrophil count less than 1,500/mm3

7. platelet count less than 100,000/mm3

8. bilirubin greater than 1.5 mg/dl (> 26 μmol/L, système internationale (SI) unit
equivalent)

9. aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than
3 times the upper limit of normal

10. serum creatinine greater than 1.5 mg/dl (> 132 μmol/L, SI unit equivalent)

11. concomitant non-oncological diseases which are considered relevant for the evaluation
of the safety of the trial drug

12. chemo- or immunotherapy within the past four weeks prior to treatment with the trial
drug or during the trial (except for present trial drug)

13. radiotherapy to breast and thorax region within the past four weeks before inclusion
or during the trial

14. women who are sexually active and unwilling to use a medically acceptable method of
contraception

15. pregnancy or lactation

16. treatment with other investigational drugs or participation in another clinical trial
within the past four weeks before start of therapy or concomitantly with this trial
(except for present trial drug)

17. patients unable to comply with the protocol