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

Boehringer Ingelheim

Status and phase: Terminated; Phase 1

Conditions: Carcinoma, Squamous Cell

Treatments: Drug: bivatuzumab mertansine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02254044

1191.4

Details and patient eligibility

About

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

Enrollment: 7 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patients from 18 to 80 years of age (both inclusive)
2. patients with histologically confirmed squamous cell carcinoma of the head and neck or esophagus
3. patients with local and / or regional recurrent disease or distant metastases who are refractory to or not amenable to established treatments
4. evaluable tumour deposits
5. life expectancy of at least 3 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)

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-, radio- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
13. men and women who are sexually active and unwilling to use a medically acceptable method of contraception
14. pregnancy or lactation
15. 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)
16. patients unable to comply with the protocol

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

bivatuzumab mertansine

Experimental group

Description:

dose escalation

Treatment:

Drug: bivatuzumab mertansine