Breast Neoplasms
Conditions
Brief summary
Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD) of bivatuzumab mertansine | up to day 21 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG) | up to day 21 | — |
| Incidence of adverse events | up to day 21 | — |
| Number of patients with clinically significant findings in laboratory tests | up to day 21 | — |
| Number of patients with development of human anti-human antibodies (HAHA) | up to day 21 | — |
| Tumor response rate | up to 1 year | assessed by response evaluation criteria in solid tumours (RECIST) |
| Concentration of bivatuzumab mertansine | up to day 21 | — |
| Number of patients with clinically significant findings in vital signs | up to day 21 | — |
Outcome results
None listed