Dose Escalation of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Recurrent or Metastatic Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

An Open Phase I Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously Once Per Week for Three Weeks in Female Patients With CD44v6 Positive Recurrent or Metastatic Breast Cancer With Repeated Administration Courses in Patients With Clinical Benefit

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02254031
• Other study ID #: 1191.3
• Status: Terminated
• Phase: Phase 1
• Start date: July 1, 2003

Study information

• Verified date: October 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. primary completion date: January 1, 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 local and / or regional recurrent disease or distant metastases who are refractory to anthracyclines and / or 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 of 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 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 prior to treatment with the trial drug 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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• bivatuzumab mertansine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD)		up to 6 months
Secondary	Incidence of adverse events	graded according to common toxicity criteria (CTC)	up to 14 days after last drug administration
Secondary	Number of patients with clinically significant findings in laboratory examinations		up to 14 days after last drug administration
Secondary	Number of patients with clinically significant findings in vital signs		up to 14 days after last drug administration
Secondary	Number of patients with development of Human Anti-Human Antibody (HAHA)		up to 14 days after last drug administration
Secondary	Area under the serum concentration time curve from time zero to time point 168 hours (AUC0-168)		up to 168 hours
Secondary	Area under the serum concentration time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz)		up to 14 days after last drug administration
Secondary	Area under the serum concentration time curve from time point zero to infinity (AUC0-8)		up to 14 days after last drug administration
Secondary	Maximum serum concentration (Cmax)		up to 14 days after last drug administration
Secondary	Time to reach maximum serum concentration (tmax)		up to 14 days after last drug administration
Secondary	Terminal elimination half-life (t1/2)		up to 14 days after last drug administration
Secondary	Mean residence time (MRT)		up to 14 days after last drug administration
Secondary	Total body clearance (CL)		up to 14 days after last drug administration
Secondary	Volume of distribution at steady state (Vss)		up to 14 days after last drug administration
Secondary	Volume of distribution during the terminal elimination phase (Vz)		up to 14 days after last drug administration
Secondary	Trough concentration at steady state (Cpre,ss)		up to 7 days after drug administration
Secondary	Minimum serum concentration during the dosing interval t at steady state (Cmin,ss)		up to 7 days after drug administration
Secondary	Linearity index (LI)		up to 14 days after last drug administration
Secondary	Accumulation factor (RA)		up to 14 days after last drug administration
Secondary	Tumor response	according to response evaluation criteria in solid tumours (RECIST)	up to 14 days after last drug administration

External Links

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