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

NCT02254005 | Completed Phase 1

• 1 other identifier: 1191.1
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) of bivatuzumab mertansine

  up to day 21

Secondary Outcomes (7)

• 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

• Concentration of bivatuzumab mertansine

  up to day 21

Study Arms (1)

single dose escalation

EXPERIMENTAL

Drug: bivatuzumab mertansine

Interventions

bivatuzumab mertansine DRUG

single dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients aged 18 years or older
• patients with breast cancer positive for CD44v6 in at least 50 % of the tumour cells
• patients with metastases pretreated with anthracyclines and taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments
• measurable tumour deposits by one or more radiological techniques (MRI, CT)
• life expectancy of at least 6 months
• Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
• patients must have given written informed consent (which must be consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation)

You may not qualify if:

• hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
• known secondary malignancy requiring therapy
• active infectious disease
• brain metastases requiring therapy
• neuropathy common toxicity criteria (CTC) grade 2 or above
• absolute neutrophil count less than 1,500/mm3
• platelet count less than 100,000/mm3
• bilirubin greater than 1.5 mg/dl (\> 26 μmol/L, système internationale (SI) unit equivalent)
• aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 3 times the upper limit of normal
• serum creatinine greater than 1.5 mg/dl (\> 132 μmol/L, SI unit equivalent)
• concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
• chemo- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
• women who are sexually active and unwilling to use a medically acceptable method of contraception
• pregnancy or lactation
• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

bivatuzumab mertansine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 1, 2014
• Study Start: October 1, 2002
• Primary Completion: December 1, 2004
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share