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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03433027




Registration number
NCT03433027
Ethics application status
Date submitted
5/02/2018
Date registered
14/02/2018

Titles & IDs
Public title
A Study of BB-401 in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Scientific title
A Phase 2 Trial of Intratumoral EGFR Antisense DNA (BB-401) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC) Who Have Failed All Available Standard Therapies
Secondary ID [1] 0 0
BB-401-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BB-401

Experimental: BB-401 - BB-401 Intratumoral injection


Treatment: Drugs: BB-401
BB-401 1.92ug/mL Intratumoral Injections, every week for up to 8 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response (OR) of the injected tumor
Timepoint [1] 0 0
Up to 20 months (estimated length of the study)
Secondary outcome [1] 0 0
Disease Control Rate (DCR)
Timepoint [1] 0 0
End of Treatment Visit (Week 9) through to study end (up to 18 months)
Secondary outcome [2] 0 0
Progression Free Survival (PFS)
Timepoint [2] 0 0
Up to 20 months (estimated length of study)
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to 20 months (estimated length of study)
Secondary outcome [4] 0 0
Duration of Response (DoR)
Timepoint [4] 0 0
20 months (estimated length of study)

Eligibility
Key inclusion criteria
Key

* Histologically or cytologically confirmed HNSCC
* Failed (or are ineligible/decline to receive) all available standard therapies
* Stable, treated brain metastases
* One target lesion defined as measurable (via RECIST v1.1), with a maximum longest diameter of 4 cm, and suitable for injection
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Agree to biopsies of a selected primary lesion and where possible of a second untreated lesion at baseline and end of treatment
* Ceased anti-cancer therapy for at least 3 weeks or 5 half-lives for chemotherapy based treatment regimen, or 4 weeks from any therapy with therapeutic biologicals or any type of investigational therapy

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Nasopharyngeal Carcinoma
* Concomitant anti-cancer therapy
* Unresolved toxicities from prior treatments
* Patients in whom the indicator lesion is at risk of hemorrhage or clinically significant swelling/inflammation

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/04/2020
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
The Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Calvary Central Districts Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Elizabeth Vale
Recruitment outside Australia
Country [1] 0 0
Russian Federation
State/province [1] 0 0
Irkutsk
Country [2] 0 0
Russian Federation
State/province [2] 0 0
Krasnodar
Country [3] 0 0
Russian Federation
State/province [3] 0 0
Leningrad Region
Country [4] 0 0
Russian Federation
State/province [4] 0 0
Saint Petersburg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Benitec Biopharma, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data for primary and secondary outcome measures will be made available for the Interim Analysis and routinely through-out the study for the Data Safety Monitoring Board

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
Data will be available within 6-8 weeks from data cut off/lock
Available to whom?
Data will only be available to the Data Safety Monitoring Board and Interim Analysis members
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03433027