Dose Escalation of Bivatuzumab Mertansine in Patients Wit... | NCT02254044

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

NCT02254044

Sponsor

Boehringer Ingelheim

Status

Terminated

Last Update Posted

Oct 1, 2014Estimated

Enrollment

7Actual

Phase

Phase 1

Conditions

Carcinoma, Squamous Cell

Interventions

bivatuzumab mertansine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2003

Primary Completion Date

Nov 2004Actual

Completion Date

Not provided

First Submitted Date

Sep 30, 2014

First Submission Date that Met QC Criteria

Sep 30, 2014

First Posted Date

Oct 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2014

Last Update Posted Date

Oct 1, 2014Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Label	Type	Description	Intervention Names
bivatuzumab mertansine	Experimental	dose escalation	Drug: bivatuzumab mertansine

Name	Type	Description	Arm Group Labels	Other Names
bivatuzumab mertansine	Drug		bivatuzumab mertansine

Measure	Description	Time Frame
Maximum tolerated dose (MTD)		up to 6 months

Measure	Description	Time Frame
Incidence of adverse events	graded according to common toxicity criteria (CTC)	up to 14 days after last drug administration
Number of patients with clinically significant findings in laboratory examinations

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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)
patients unable to comply with the protocol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms