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

Sponsor

Agennix (Industry)

Overall Status

Completed

CT.gov ID

NCT00707304

Collaborator

(none)

742

Enrollment

189

Locations

Arms

Duration (Months)

3.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

742 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Talactoferrin Oral, 1.5 grams twice per day Other Names: talactoferrin alfa TLF recombinant human lactoferrin rhLF
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.	Drug: Placebo Oral, twice per day

Arm

Intervention/Treatment

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.

Drug: Talactoferrin

Oral, 1.5 grams twice per day

Other Names:

talactoferrin alfa

TLF

recombinant human lactoferrin

rhLF

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.

Drug: Placebo

Oral, twice per day

Outcome Measures

Primary Outcome Measures

Overall survival [After the occurence of the required number of events]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Desert Oasis Cancer Center	Casa Grande	Arizona	United States	85122
2	Arizona Oncology Associates	Tucson	Arizona	United States	85710
3	University of Colorado Hospital	Aurora	Colorado	United States	80045
4	Pasco Pinellas Cancer Center	New Port Richey	Florida	United States	34652
5	Emory University	Atlanta	Georgia	United States	30322
6	Rush University Medical Center	Chicago	Illinois	United States	60612
7	Cancer Care Specialists of Central Illinois	Decatur	Illinois	United States	62526
8	Cancer Care & Hematology Specialists of Chicagoland	Niles	Illinois	United States	60714
9	Central Indiana Cancer Centers	Greenfield	Indiana	United States	46140
10	Kansas City Cancer Center, LLC	Overland Park	Kansas	United States	66210
11	NCI, CCR, The Waren Grant Magnuson Clinical Center	Bethesda	Maryland	United States	20892
12	Newland Medical Associates	Southfield	Michigan	United States	48075
13	Minnesota Oncology and Hematology, PA	Minneapolis	Minnesota	United States	55405
14	Washington University School of Medicine	St. Louis	Missouri	United States	63128
15	Southeast Nebraska Cancer Center	Lincoln	Nebraska	United States	68510
16	NH Oncology-Hematology, PA	Hooksett	New Hampshire	United States	03106
17	Montefiore Medical Center	Bronx	New York	United States	10467
18	University of Rochester Medical Center	Rochester	New York	United States	14642
19	Alamance Regional Medical Center	Burlington	North Carolina	United States	27216
20	Duke University Medical Center	Durham	North Carolina	United States	27710
21	Rex Cancer Center	Raleigh	North Carolina	United States	27609
22	Legacy Pharma Research	Bismarck	North Dakota	United States	58501
23	Signal Point Clinical Research Center	Middletown	Ohio	United States	45042
24	Kaiser Group Health	Portland	Oregon	United States	97227
25	Texas Oncology	Dallas	Texas	United States	75230
26	Texas Oncology	Fort Worth	Texas	United States	76104
27	Tyler Cancer Center	Tyler	Texas	United States	75702
28	Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care	Salem	Virginia	United States	24153
29	Cancer Care Northwest	Spokane	Washington	United States	99202
30	Campbelltown Hospital	Campbelltown	New South Wales	Australia	2560
31	Port Macquarie Base Hospital	Port Macquarie	New South Wales	Australia	2444
32	Townsville Hospital	Townsville	Queensland	Australia	4814
33	The Queen Elisabeth Hospital	Woodville South	South Australia	Australia	5011
34	Epworth Healthcare	Richmond	Victoria	Australia	3121
35	DDODIU-Plovdiv, EOOD	Aleksandur Stamboliyski	Plovdiv	Bulgaria	4004
36	UMHAT 'Dr. Georgi Stranski', EAD	Pleven		Bulgaria	5800
37	DDODIU-Plovdiv, EOOD	Plovdiv		Bulgaria	4004
38	DDODIU - Sofia District EOOD	Sofia		Bulgaria	1233
39	UMHAT 'Tsaritsa Yoanna - ISUL', EAD	Sofia		Bulgaria	1527
40	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
41	Mount Sinai Hospital	Toronto	Ontario	Canada	M5G 1X5
42	Hôtel-Dieu de Lévis	Lévis	Quebec	Canada	G6V 3Z1
43	Gerald Bronfman Centre for Clinical Research in Oncology	Montreal	Quebec	Canada	H3A 1A1
44	Fakultni nemocnice Na Bulovce	Budinova	Praha	Czech Republic	180 00
45	Institut Onkologie a Rehabilitace Na Plesi	Nova Ves pod Plesi		Czech Republic	262 04
46	Vitkovicka nemocnice a.s.	Ostrava		Czech Republic	700 30
47	Fakultni Nemocnice Ostrava	Ostrava		Czech Republic	708 52
48	Pardubicka krajska nemocnice, a.s.	Pardubice		Czech Republic	532 03
49	Fakultni Nemocnice Kralovske Vinohrady	Praha		Czech Republic	100 00
50	Fakultni nemocnice v Motole, s.p.	Praha		Czech Republic	150 06
51	Oblastni nemocnice Pribram, a.s.	Pribram		Czech Republic	261 95
52	Nemocnice Tabor, a.s.	Tabor		Czech Republic	390 03
53	Hopital Cardiologique, Chru Lille	Lille	Cedex	France	590
54	CHU Pontchaillou	Rennes	Cedex	France	35033
55	CRLCC René Gauducheau	Saint-herblain	Cedex	France	44805
56	CLCC Paul Strauss	Strasbourg	Cedex	France	67085
57	Hopital Larrey	Toulouse	Cedex	France	31059
58	Centre Catherine de Sienne	Eric Tabarly	Nantes	France	44202
59	CHU Angers	Angers cedex		France	49933
60	Hopital Morvan	Brest		France	29200
61	Centre Francois Baclesse	Caen Cedex		France	14076
62	Centre d'Oncology de Gentilly	Cedex		France	54100
63	Centre Hospitalier du Mans	Le Mans Cedex		France	72037
64	Centre Léon Berard	Lyon		France	69008
65	Hopital Sainte Marguerite	Marseille Cedex 9		France	13274
66	Hôpital Saint-Antoine	Paris		France	75012
67	Centre Hospitalier Lyon Sud	Pierre Bénite Cedex		France	69495
68	Hopital Maison Blanche	Reims		France	51100
69	CHU de Nancy, Hopital de Brabois	Vandoeuvre les Nancy		France	54500
70	Praxis fuer interdisziplinaere Onkologie	Freiburg	BW	Germany	79106
71	Universitaetsklinikum Mannheim	Mannheim	BW	Germany	68167
72	Universitaetsklinikum Erlangen - PS	Erlangen	BY	Germany	91054
73	Asklepios Fachkliniken Muenchen-Gauting	Gauting	BY	Germany	82131
74	Klinikum rechts der Isar der TU Muenchen	Muenchen	BY	Germany	81675
75	Gemeinschaftspraxis fuer Haematologie Onkologie	Wiesbaden	HE	Germany	65191
76	Universitaetsklinikum Goettingen	Goettingen	NI	Germany	37075
77	St. Johannes Hospital - PS	Dortmund	NW	Germany	44137
78	Krankenhaus Grosshansdorf	Woehrendamm	SH	Germany	22927
79	Staedt. Krankenhaus Martha-Maria Halle-Doelau gGmbH	Halle	ST	Germany	06120
80	Zentralklinik Bad Berka	Bad Berka	TH	Germany	99437
81	Thoraxklinik-Heidelberg gGmbH	Heidelberg		Germany	69126
82	General Hospital of Chania 'Ag. Georgios'	Mournies	Crete	Greece	73300
83	University Hospital of Larissa	Mezourlo	Larissa	Greece	411 10
84	University General Hospital of Patras	Rion	Patras	Greece	26505
85	General Hospital of Athens "Sotiria"	Athens		Greece	11527
86	University Hospital of Heraklio	Crete		Greece	71110
87	General Hospital of Thessaloniki "G. Papanikolaou"	Thessaloniki		Greece
88	Miskolc Megyei Jogu Varos Onkormanyzat Miskolci Egeszsegugyi	Csabai kapu	Miskolc	Hungary	3529
89	Fejer Megyei Szent Gyorgy Korhaz	Seregelyesi	Szekesfehervar	Hungary	8000
90	Semmelweis Egyetem	Budapest		Hungary	1125
91	Orszagos Koranyi TBC es Pulmonologiai Intezet	Budapest		Hungary	1529
92	Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz	Miskolc		Hungary	3526
93	Szabolcs-Szatmar Bereg Megyei Josa Andras Oktato Korhaz	Nyiregyháza		Hungary	4412
94	Torokbalinti Tudogyogyintezet	Torokbalint		Hungary	2045
95	Zala Megyei Korhaz	Zalaegerszeg		Hungary	8900
96	King George Hospital	Vishakhapattanam	Andhhra Pradesh	India	530002
97	Apollo Hospital	Hyderabad	Andhra Pradesh	India	500033
98	Indo-American Cancer Institute and Research Center	Hyderabad	Andhra Pradesh	India	500034
99	Kidwai Institute of Oncology	Bangalore	Karnataka	India	560029
100	M. S. Ramaiah Memorial Hospital	Bangalore	Karnataka	India	560054
101	A.J. Medical College Hosptial	Mangalore	Karnataka	India	575001
102	Tata Memorial Hospital	Mumbai	Maharashtra	India	400 012
103	P.D. Hinduja Nat. Hospital & Med. Research Centre	Mumbai	Maharashtra	India	400016
104	Kaushalya Medical Foundation Trust Hospital	Mumbai	Maharashtra	India	400601
105	Cancer Care Clinic	Nagpur	Maharashtra	India	440012
106	Shatabdi Hospital	Nashik	Maharashtra	India	422005
107	Deenanath Mangeshkar Hospital and Research Center	Pune	Maharashtra	India	411 004
108	Searoc Cancer Hospital	Jaipur	Rajasthan	India	302013
109	Mahaveer Cancer Hospital and Research Centre	Jaipur	Rajasthan	India	302017
110	Dr. Kamakshi Memorial Hospital Pvt Ltd	Chennai	Tamilnadu	India	600100
111	Christian Medical College Hospital	Vellore	Tamilnadu	India	632002
112	Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I	Ancona	AN	Italy	60020
113	Istituto per la Ricerca e la Cura del Cancro	Candiolo	Candiolo/TO	Italy	10060
114	Ospedale Versilia	Lido di Camaiore	LU	Italy	55043
115	Istituto Nazionale Tumori	Milano	MI	Italy	20133
116	Azienda Ospedaliera San Gerardo	Monza	MI	Italy	20052
117	Azienda Ospedaliera San Camillo Forlanini	Roma,	RM	Italy
118	Ospedale Mater Salutis	Legnago	VR	Italy	37045
119	CRO Centro di Riferimento Oncologico di Aviano	Aviano		Italy	33081
120	Azienda Ospedaliera Istituti Ospitalieri di Cremona	Cremona		Italy	26100
121	Chonnam National University Hwasun Hospital	Hwasun up	Chonnam	Korea, Republic of	519-809
122	National Cancer Center	Ilsandong-gu	Goyang	Korea, Republic of	411-769
123	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do,	Korea, Republic of	463-707
124	Samsung Medical Center	Gangnam-Gu	Seoul	Korea, Republic of	135-710
125	Seoul National University Hospital	Jongno-gu	Seoul	Korea, Republic of	110-744
126	Korea University Anam Hospital	Seongbuk-gu	Seoul	Korea, Republic of	136-705
127	Asan Medical Center	Songpa-gu	Seoul	Korea, Republic of	138-736
128	The Catholic University of Korea St. Vincent's Hospital	Paldal-gu	Suwon Gyeonggi-do	Korea, Republic of	442-723
129	Dr. Anna Levcenko GP and Internist Practice	Daugavpils		Latvia	LV-5403
130	Piejuras Hospital	Liepaja		Latvia	LV-4301
131	Riga Eastern Clinical University Hospital	Riga		Latvia	LV-1079
132	P. Stradina Clinical University Hospital	Riga		Latvia	LV1002
133	Nilai Cancer Institute (NCI Cancer Hospital)	Negeri Sembilan	Darul Khusus	Malaysia	71800
134	Lam Wah Ee Hospital	Pulau Pinang	Georgetown,	Malaysia	11600
135	Hospital Universiti Sains Malaysia	Kubang Kerian	Kelantan	Malaysia	16150
136	Hospital Tengku Ampuan Afzan	Kuantan	Pahang	Malaysia	25100
137	Manila Doctors Hospital	Manila		Philippines	1000
138	Lung Center of the Philippines	Quezon City		Philippines	1100
139	St. Luke's Medical Center	Quezon City		Philippines	1102
140	Akademickie Centrum Kliniczne - Szpital AM w Gdansku	Gdansk		Poland	80-952
141	Nzoz Vesalius	Krakow		Poland	31-108
142	Miedziowe Centrum Zdrowia S.A.	Lubin		Poland	59-301
143	NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o	Olsztyn		Poland	10-513
144	Specjalistyczny Szpital im. Prof. A. Sokolowskiego	Szczecin		Poland	70-891
145	Centrum Onkologii-Instytut im. M. Sklodowskiej Curie	Warszawa		Poland	02-781
146	Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca	Str. Republicii nr. 34-36	Cluj-Napoca	Romania	400015
147	Spitalul Judetean de Urgenta "Dr. Constantin Opris"	Baia Mare		Romania	430031
148	Spitalul Judetean de Urgenta Braila	Braila		Romania	810325
149	S.C. Ianuli Med Consult S.R.L.	Bucuresti		Romania	020962
150	Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca	Cluj-Napoca		Romania	400015
151	Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava	Suceava		Romania	720237
152	Oncology Dispensary #2 of Krasnodar Region	Dagomysskaya str.	Sochi	Russian Federation	354057
153	Arkhangelsk Regional Clinical Oncology Dispensary	Arkhangelsk		Russian Federation	163045
154	SHI Altay Regional Oncology Dispensary	Barnaul		Russian Federation	656052
155	CCH #2 n.a. N. A. Semashko of LLC "Russian Railways"	Moscow		Russian Federation	129128
156	City Clinical Hospital #1	Novosibirsk		Russian Federation	630047
157	Perm Territorial Oncology Dispensary	Perm		Russian Federation	614066
158	SEIHPE "Saint Petersburg SMU RosZdrav n.a. I.I.Pavlov"	St. Petersburg		Russian Federation	197022
159	National Cancer Centre	Hospital Drive		Singapore	169610
160	Parkway Cancer Centre	Mount Elizabeth		Singapore	258500
161	Medical Oncology Centre	Napier Road		Singapore	258500
162	John Hopkins Singapore International Medical Centre	Singapore		Singapore	308433
163	H Mutua de Terrassa	Barcelona		Spain	08221
164	HU Virgen de las Nieves	Granada		Spain	18014
165	Fundacion Jimenez Diaz	Madrid		Spain	28040
166	HGU La Paz	Madrid		Spain	28046
167	Clinica Universitaria de Navarra	Pamplona		Spain	31008
168	Changhua Christian Hospital	Changhua		Taiwan	500
169	Kaohsiung Veterans General Hospital	Kaohsiung,		Taiwan	813
170	Taichung Veterans General Hospital	Taichung		Taiwan	403
171	National Cheng Kung University Hospital	Tainan		Taiwan	70428
172	Taipei Veterans General Hospital	Taipei		Taiwan	112
173	Chang-Gung Memorial Hospital, Linkou Branch	Toayuan		Taiwan	333
174	Gazi University Medical Faculty	Ankara		Turkey	06500
175	Gaziantep University Medical Faculty	Gaziantep		Turkey
176	Istanbul Bilim University Medical Fac.	Istanbul		Turkey	34394
177	Ege University Medical Faculty	Izmir		Turkey	35100
178	Bristol Haematology & Oncology Centre	Bristol	Brist	United Kingdom	BS2 8ED
179	Guy's & St Thomas' NHS Foundation Trust	London	Gt Lon	United Kingdom	SE1 9RT
180	Christie Hospital	Manchester	Gt Man	United Kingdom	M20 4BX
181	Southampton General Hospital	Southampton	Hants	United Kingdom	SO16 6YD
182	Castle Hill Hospital	Cottingham Hull	Hull	United Kingdom	HU16 5JQ
183	University Hospital of South Manchester NHS Foundation Trust Wythenshawe Hospital	Wythenshawe	Manchester	United Kingdom	M23 9LT
184	Singleton Hospital	Swansea,	S Glam,	United Kingdom	SA2 8QA
185	University Hospital of North Staffordshire	Stoke on Trent	Staffs	United Kingdom	ST4 7LN
186	Wolverhampton New Cross Hospital	Wolverhampton	Staffs	United Kingdom	WV10 0QP
187	Beatson West of Scotland Cancer Centre	Glasgow	Strath	United Kingdom	G12 0YN
188	Ninewells Hospital	Dundee	Tays	United Kingdom	DD1 9SY
189	University Hospital of Coventry and Warwickshire	Coventry	Warwks	United Kingdom	CV2 2DX