Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-Small Cell Lung Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Non Small Cell Lung Cancer	Drug: Talactoferrin Drug: Placebo	Phase III

MedlinePlus related topics:

Cancer Lung Cancer

Drug Information available for:

Talactoferrin Alfa Lactoferrin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official 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

Further study details as provided by Agennix:

Primary Outcome Measures:

Overall survival [ Time Frame: After the occurence of the required number of events ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression free survival [ Time Frame: At time of final analysis ] [ Designated as safety issue: No ]
Objective response and disease stablization rate [ Time Frame: At time of final analysis ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: At time of final analysis ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	720
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Talactoferrin	Drug: Talactoferrin Oral, 1.5 grams twice per day
2: Placebo Comparator Placebo	Drug: Placebo Oral, twice per day

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707304

Contacts


Contact: Yenyun Wang, MD	713-552-1091	ywang@agennix.com

Contact: Rajesh Malik, MD	713-552-1091	rmalik@agennix.com

Sponsors and Collaborators

Agennix

More Information

Responsible Party:	Agennix Incorporated ( Rajesh Malik, MD Chief Medical Officer )
Study ID Numbers:	LF-0207
First Received:	June 26, 2008
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00707304
Health Authority:	United States: Food and Drug Administration

Keywords provided by Agennix:

Non Small Cell Lung Cancer

Talactoferrin

Dendritic Cell Recruiter and Activator

Immunomodulatory agent

Study placed in the following topic categories:

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Agennix
Information provided by:	Agennix
ClinicalTrials.gov Identifier:	NCT00707304