Dose Escalation of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus

NCT02254044 | Terminated Phase 1

• 1 other identifier: 1191.4
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Carcinoma, Squamous Cell

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

You may qualify if:

• patients from 18 to 80 years of age (both inclusive)
• patients with histologically confirmed squamous cell carcinoma of the head and neck or esophagus
• patients with local and / or regional recurrent disease or distant metastases who are refractory to or not amenable to established treatments
• evaluable tumour deposits
• life expectancy of at least 3 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 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-, radio- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
• men and 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

Carcinoma, Squamous Cell

Interventions

bivatuzumab mertansine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

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, 2003
• Primary Completion: November 1, 2004
• Last Updated: October 1, 2014

Record last verified: 2014-09