Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000185268
Ethics application status
Approved
Date submitted
9/10/2008
Date registered
17/04/2009
Date last updated
17/04/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
LBH589 in combination with External Beam Radiotherapy or Chemoradiation for Locally Advanced Non Small Cell Lung Cancer
Scientific title
A dose finding study of oral LBH589 with radiation with or without chemotherapy for Stage III Non Small Cell Lung Cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 3812 0
Condition category
Condition code
Cancer 3994 3994 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group 1:
LBH589, an oral histone deacetylase inhibitor, will be combined with radiation for treatment of stage III non small cell lung cancer (NSCLC) in 3 increasing dose levels- 20 mg, 30 mg and 45 mg. The drug is administered orally. The radiation will be delivered to a total dose of 40 Gy in 2 Gy per fraction. 3 patients will start treatment with 20 mg LBH589 and radiation and observed for dose limiting toxicities. In case of no or minimal toxicities the next 3 patients will be treated at second dose level i.e. 30 mg. The next and final dose level will be 45 mg. A patient will be treated at only one particular dose level. The treatment will last for the duration of radiation, i.e. 4 weeks.
Intervention group 2:
Patients with stage III NSCLC will be treated with chemoradiation plus LBH589 in three increasing dose levels 20 mg, 30 mg and 45 mg. The total treatment duration will be 6 weeks. Radiation will be given at the dose of 60 Gy- 2 Gy per fraction. The chemotherapy will be intravenous cisplatin (50mg/m2 Days 1, 8 every 3 weeks) plus oral vinorelbine (50mg/m2 Days 1, 8 every 3 weeks) for 2 cycles. The first 3 patients will start treatment at 20 mg LBH589 with chemoradiation and observed for dose limiting toxicities. In case of no or minimal toxicities, the next three patients will be treated at 30 mg dose level. The final dose level will be 45 mg. The dose of chemotherapy and raditaion will remain constant throughout. A patient will be treated at only one dose level of LBH589 whether they experience any toxicity or not.
Intervention code [1] 3532 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4898 0
dose limiting toxicity and maximum tolerated dose using classical Fibonacci's phase I trial design.
Timepoint [1] 4898 0
The patients will be assessed for toxicities twice a week during treatment. Final assessment will be at week 4 after last treatment.
Secondary outcome [1] 8273 0
response rate using computerised tomography (CT) scan
Timepoint [1] 8273 0
4 weeks after completion of radiation

Eligibility
Key inclusion criteria
Histological or cytological diagnosis of locally advanced (stage III) NSCLC
Adequate organ function
Performance score < 2
Adequate lung functions with forced expiratory volume (FEV1) > 1 L
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Concurrent treatment with other histone deacetylase inhibitors such as sodium valproate
Concurrent treatment with anti-arrythmics with a tendency to prolong QTc interval.
Patients on other investigational drugs within last 30 days
Pregnant or lactating females
Patients who have any severe and/or uncontrolled medical conditions
Malabsorption syndrome

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4044 0
Commercial sector/Industry
Name [1] 4044 0
Novartis Pharmaceuticals Australia Pty Limited
Country [1] 4044 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace
Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 3730 0
None
Name [1] 3730 0
Address [1] 3730 0
Country [1] 3730 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6071 0
Royal Adelaide Hospital
Ethics committee address [1] 6071 0
Ethics committee country [1] 6071 0
Date submitted for ethics approval [1] 6071 0
Approval date [1] 6071 0
Ethics approval number [1] 6071 0

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

Contacts
Principal investigator
Name 29024 0
Address 29024 0
Country 29024 0
Phone 29024 0
Fax 29024 0
Email 29024 0
Contact person for public queries
Name 12181 0
Nimit Singhal
Address 12181 0
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 12181 0
Australia
Phone 12181 0
+61 8 882224398
Fax 12181 0
+61 8 882224358
Email 12181 0
[email protected]
Contact person for scientific queries
Name 3109 0
Nimit Singhal
Address 3109 0
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 3109 0
Australia
Phone 3109 0
+61 8 882224398
Fax 3109 0
+61 8 882224358
Email 3109 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.