Safety and Efficacy of Talactoferrin in Addition to Standard Chemotherapy in Patients With Non-small Cell Lung Cancer

NCT00706862 | Unknown Phase 3 DMC

• 1 other identifier: LF-0208
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of the study is to determine whether the combination of talactoferrin, carboplatin and paclitaxel improves progression free survival and overall survival in patients with non-small cell lung cancer compared to the combination of paclitaxel and carboplatin alone

Conditions

Non Small Cell Lung Cancer

Keywords

Non small cell lung cancer; Talactoferrin; Dendritic cell recruiter and activator; DCRA; Immunomodulatory agent; Lactoferrin

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  After the occurence of the required number of events

• Progression free survival

  At the time of final analysis

Secondary Outcomes (2)

• Objective response and disease stabilization rate

  At the time of final analysis

• Safety and tolerability

  At the time of final analysis

Study Arms (2)

1

EXPERIMENTAL

Talactoferrin, Carboplatin, Paclitaxel

Drug: Talactoferrin

2

PLACEBO COMPARATOR

Placebo, Carboplatin, Paclitaxel

Drug: Placebo

Interventions

Talactoferrin DRUG

Oral, 1.5 grams twice per day

Also known as: talactoferrin alfa, TLF, recombinant human talactoferrin, rhLF

1

Placebo DRUG

Oral, twice per day

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed locally advanced or metastatic non-small cell lung cancer that is unresectable
• At least 1 unirradiated target lesion measurable by RECIST
• Adequate hematologic, renal and hepatic function
• ECOG 0,1
• Able to understand and sign an Informed Consent

You may not qualify if:

• 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
• Received prior systemic anti-cancer therapy for NSCLC
• History of allergic reactions to compounds of similar chemical or biologic composition to talactoferrin or the chemotherapy drugs
• 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 render compliance or follow-up in the protocol problematic
• Concurrent radiotherapy or radiotherapy within 4 weeks prior to randomization or previous radiotherapy at the indicator sites (the sites that are to be followed for determination of a response)
• Concurrent systemic corticosteroid therapy within 4 weeks prior to randomization, except prophylactic use of steroids prior to paclitaxel administration
• 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 for 30 days after completion of treatment

Sponsors & Collaborators

• Agennix: lead

Study Sites (6)

City of Hope

Duarte, California, 91010, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

WITHDRAWN

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Chattanooga Oncology and Hematology Associates

Chattanooga, Tennessee, 37404, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

talactoferrin alfa

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yenyun Wang, MD

CONTACT

713-552-1091; ywang@agennix.com

Rajesh Malik, MD

CONTACT

713-552-1091; rmalik@agennix.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: June 30, 2008
• Study Start: February 1, 2009
• Primary Completion: June 1, 2015
• Study Completion: March 1, 2016
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

US (6)