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

NCT02254031 | Terminated Phase 1

• 1 other identifier: 1191.3
• Study Type: interventional
• Target: 8
• 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)

  up to 6 months

Secondary Outcomes (19)

• Incidence of adverse events

  up to 14 days after last drug administration

• Number of patients with clinically significant findings in laboratory examinations

  up to 14 days after last drug administration

• Number of patients with clinically significant findings in vital signs

  up to 14 days after last drug administration

• Number of patients with development of Human Anti-Human Antibody (HAHA)

  up to 14 days after last drug administration

• Area under the serum concentration time curve from time zero to time point 168 hours (AUC0-168)

  up to 168 hours

Study Arms (1)

bivatuzumab mertansine

EXPERIMENTAL

dose escalation

Drug: bivatuzumab mertansine

Interventions

bivatuzumab mertansine DRUG

bivatuzumab mertansine

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 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
• 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 of 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 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)
• radiotherapy to breast and thorax region within the past four weeks prior to treatment with the trial drug or during the trial
• women who are sexually active and unwilling to use a medically acceptable method of contraception
• pregnancy or lactation

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: July 1, 2003
• Primary Completion: January 1, 2005
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share