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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00707304




Registration number
NCT00707304
Ethics application status
Date submitted
26/06/2008
Date registered
30/06/2008
Date last updated
21/08/2012

Titles & IDs
Public title
Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer
Scientific title
FORTIS-M: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Oral Talactoferrin in Addition to Best Supportive Care in Patients With Non-small Cell Lung Cancer Who Have Failed Two or More Prior Treatment Regimens
Secondary ID [1] 0 0
LF-0207
Universal Trial Number (UTN)
Trial acronym
FORTIS-M
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

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

Experimental: 1 - Talactoferrin alfa (talactoferrin or TLF, also known as recombinant human lactoferrin, rhLF or talactoferrinum alfa) is a recombinant version of the glycoprotein expressed in and purified from Aspergillus niger var. awamori. Talactoferrin is structurally and functionally similar to native human lactoferrin. The structural equivalence of talactoferrin to native human lactoferrin has been demonstrated by a comparison of the 3-dimensional structure, molecular weight, biological activity and other physicochemical properties, and is known to differ only in the nature of glycosylation.

Placebo Comparator: 2 - Placebo contains the same phosphate-based buffer used as the diluent for the talactoferrin solution. In addition, the placebo will contain FD&C/EU grade dyes suitable for oral use to mimic the color of the vialed drug product.


Treatment: Drugs: Talactoferrin
Oral, 1.5 grams twice per day

Treatment: Drugs: Placebo
Oral, twice per day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
After the occurence of the required number of events
Secondary outcome [1] 0 0
Progression free survival
Timepoint [1] 0 0
At time of final analysis
Secondary outcome [2] 0 0
Objective response and disease stablization rate
Timepoint [2] 0 0
At time of final analysis
Secondary outcome [3] 0 0
Safety and tolerability
Timepoint [3] 0 0
At time of final analysis

Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed stage IIIB or IV NSCLC

- Failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic NSCLC

- At least one target lesion that is unirradiated and measurable by RECIST

- Adequate hematologic, renal and hepatic function

- ECOG 0, 1, or 2

- Able to understand and sign an Informed Consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Presence of brain metastases, unless the patient received brain irradiation, including
adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is
stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization

- Any gastrointestinal tract disease or other medical condition resulting in the
inability to take oral medications

- History of other malignancies except: (i) adequately treated basal or squamous cell
carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine
cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other
curatively treated solid tumor with no evidence of disease for = 5 years

- Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart
failure

- Serious active infection

- Psychiatric illness/ social situations that would limit study compliance

- Other uncontrolled serious chronic disease or conditions that in the investigator's
opinion could affect compliance or follow-up in the protocol

- Concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to
randomization or previous radiotherapy to the target lesion sites (the sites that are
to be followed for determination of a response)

- Known HIV positive or on active anti-retroviral therapy

- Known Hepatitis B surface antigen positive or hepatitis C positive

- Receipt of any investigational medication within 4 weeks prior to randomization

- Pregnant or lactating patients, or fertile female patients with a positive pregnancy
test, or fertile female patients unwilling to use adequate contraception during
treatment and 30 days after completion of treatment

- Sexually active male patients unwilling to practice contraception while participating
on the study and up to 30 days after completion of treatment

- Legal incapacity or limited legal capacity, unless authorization is granted by a legal
guardian

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/11/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2012
Sample size
Target
Accrual to date
Final
742
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [3] 0 0
Townsville Hospital - Townsville
Recruitment hospital [4] 0 0
The Queen Elisabeth Hospital - Woodville South
Recruitment hospital [5] 0 0
Epworth Healthcare - Richmond
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
4814 - Townsville
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3121 - Richmond
Recruitment outside Australia
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Gaziantep
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Istanbul
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Izmir
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Brist
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Hants
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Hull
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Manchester
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S Glam,
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Staffs
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Strath
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Warwks

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Agennix
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether talactoferrin can improve overall survival
in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two
or more regimens.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00707304
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00707304