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

NCT ID: NCT02254018

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-01

Brief Summary

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

Conditions

Head and Neck Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bivatuzumab mertansine

single dose escalation

Group Type: EXPERIMENTAL

bivatuzumab mertansine

Intervention Type: DRUG

Interventions

bivatuzumab mertansine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. male and female patients aged 18 years or older

2. patients with histologically confirmed squamous cell carcinoma of the head and neck

3. patients with local and / or regional recurrent disease or distant metastases who are refractory to 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 of 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

5. neuropathy grade 2 or above (excluding pre-existing neuropathy of cranial nerves due to surgery, radiotherapy or tumour growth)

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 three weeks prior to treatment with the trial drug or during the trial

13. radiotherapy to head and neck region within the past four weeks before inclusion or during the trial

14. men and 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 three weeks before start of therapy or concomitantly with this trial

17. patients unable to comply with the protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1191.2

Identifier Type: -

Identifier Source: org_study_id