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

Head and Neck Neoplasms Clinical Trial

Official title:

An Open Phase I Single Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck With Repeated Administration in Patients With Clinical Benefit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02254018
• Other study ID #: 1191.2
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2002

Study information

• Verified date: October 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. primary completion date: February 1, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• bivatuzumab mertansine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD) of bivatuzumab mertansine		up to day 21
Secondary	Number of patients with adverse events	grading according to the common toxicity criteria (CTC)	up to day 21
Secondary	Number of patients with clinically significant changes in laboratory parameters		up to day 21
Secondary	Number of patients with clinically significant changes in vital signs		up to day 21
Secondary	Tumor response	according to the response evaluation criteria in solid tumours (RECIST)	up to 1 year
Secondary	Concentration of bivatuzumab mertansine		up to day 21
Secondary	Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG)		up to day 21
Secondary	Number of patients with development of human anti-human antibodies (HAHA)		up to day 21

External Links

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