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

Sponsor

Agennix (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00706862

Collaborator

(none)

1,100

Enrollment

Locations

Arms

84.9

Duration (Months)

183.3

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: Talactoferrin Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

FORTIS-C: A Phase 3, Randomized, Placebo-controlled Study of Oral Talactoferrin in Combination With Carboplatin and Paclitaxel as First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Study Start Date :

Feb 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2015

Anticipated Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Talactoferrin, Carboplatin, Paclitaxel	Drug: Talactoferrin Oral, 1.5 grams twice per day Other Names: talactoferrin alfa TLF recombinant human talactoferrin rhLF
Placebo Comparator: 2 Placebo, Carboplatin, Paclitaxel	Drug: Placebo Oral, twice per day

Arm

Intervention/Treatment

Experimental: 1

Talactoferrin, Carboplatin, Paclitaxel

Drug: Talactoferrin

Oral, 1.5 grams twice per day

Other Names:

talactoferrin alfa

TLF

recombinant human talactoferrin

rhLF

Placebo Comparator: 2

Placebo, Carboplatin, Paclitaxel

Drug: Placebo

Oral, twice per day

Outcome Measures

Primary Outcome Measures

Overall Survival [After the occurence of the required number of events]
Progression free survival [At the time of final analysis]

Secondary Outcome Measures

Objective response and disease stabilization rate [At the time of final analysis]
Safety and tolerability [At the time of final analysis]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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
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
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

Locations

	Site	City	State	Country	Postal Code
1	City of Hope	Duarte	California	United States	91010
2	Rush University Medical Center	Chicago	Illinois	United States	60612
3	Montefiore Medical Center	Bronx	New York	United States	10467
4	Duke University Medical Center	Durham	North Carolina	United States	27710
5	Chattanooga Oncology and Hematology Associates	Chattanooga	Tennessee	United States	37404
6	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203