Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer

Phase 3

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Placebo; Drug: Talactoferrin

• Registration Number: NCT00707304
• Lead Sponsor: Agennix

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-26
• Study First Submitted QC: 2008-06-26
• Study First Posted: 2008-06-30
• Study Start: 2008-11
• Primary Completion: 2011-03
• Status Verified: 2012-08
• Study Completion: 2012-08
• Disposition First Submitted: 2012-08-13
• Disposition First Submitted QC: 2012-08-13
• Last Update Submitted: 2012-08-13
• Disposition First Posted: 2012-08-21
• Last Update Posted: 2012-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 742

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	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.
1	Talactoferrin	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	After the occurence of the required number of events

Secondary Outcome Measures

Name	Time	Method
Progression free survival	At time of final analysis
Objective response and disease stablization rate	At time of final analysis
Safety and tolerability	At time of final analysis

Trial Locations

Locations (186)

Desert Oasis Cancer Center; 🇺🇸 Casa Grande, Arizona, United States

Arizona Oncology Associates; 🇺🇸 Tucson, Arizona, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Pasco Pinellas Cancer Center; 🇺🇸 New Port Richey, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Cancer Care Specialists of Central Illinois; 🇺🇸 Decatur, Illinois, United States

Cancer Care & Hematology Specialists of Chicagoland; 🇺🇸 Niles, Illinois, United States

Central Indiana Cancer Centers; 🇺🇸 Greenfield, Indiana, United States

Kansas City Cancer Center, LLC; 🇺🇸 Overland Park, Kansas, United States

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