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

Phase 1

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: bivatuzumab mertansine

• Registration Number: NCT02254005
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10-01
• Primary Completion: 2004-12-01
• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-09-30
• Study First Posted: 2014-10-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single dose escalation	bivatuzumab mertansine	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) of bivatuzumab mertansine	up to day 21

Secondary Outcome Measures

Name	Time	Method
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 clinically significant findings in vital signs	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
Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG)	up to day 21
Number of patients with development of human anti-human antibodies (HAHA)	up to day 21