Clinical trial NCT02254018: Single Dose Escalation Study of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head and Neck Neoplasms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-01
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Maximum tolerated dose (MTD) of bivatuzumab mertansine
timeFrame: up to day 21
Secondary outcomes:
measure: Number of patients with adverse events
timeFrame: up to day 21
measure: Number of patients with clinically significant changes in laboratory parameters
timeFrame: up to day 21
measure: Number of patients with clinically significant changes in vital signs
timeFrame: up to day 21
measure: Tumor response
timeFrame: up to 1 year
measure: Concentration of bivatuzumab mertansine
timeFrame: up to day 21
measure: Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG)
timeFrame: up to day 21
measure: Number of patients with development of human anti-human antibodies (HAHA)
timeFrame: up to day 21
Other outcomes:
Locations:
Study officials:
References: