Phase III Lucanix™ Vaccine Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Following Front-line Chemotherapy - Full Text View

Sponsor:	NovaRx Corporation
Information provided by:	NovaRx Corporation
ClinicalTrials.gov Identifier:	NCT00676507

Purpose

Rationale: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than a placebo as maintenance therapy in treatment of subjects with non-small cell lung cancer.

Purpose: This randomized phase III trial is studying vaccine therapy to see how well it works compared with a placebo in treating subjects with stage III or stage IV non-small cell lung cancer.

Condition	Intervention	Phase
Lung Neoplasm Carcinoma, Non-Small-Cell Lung: Stage IIIA (T3,N2 Only) Carcinoma, Non-Small-Cell Lung: Stage IIIB Carcinoma, Non-Small-Cell Lung: Stage IV	Biological: Lucanix™ Other: Placebo Comparator	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Phase III Study of Lucanix™ (Belagenpumatucel-L) in Advanced Non-small Cell Lung Cancer: An International Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Lucanix™ Maintenance Therapy for Stages III/IV NSCLC Subjects Who Have Responded to or Have Stable Disease Following One Regimen of Front-line, Platinum-based Combination Chemotherapy

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by NovaRx Corporation:

Primary Outcome Measures:

Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix™) vs placebo. [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the progression free survival (PFS) of subjects treated with Lucanix™ compared to treatment within the Best Support Care control group. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Evaluate the quality of life (QOL) as determined by the Lung Cancer Symptom Scale (LCSS) compared to treatment within the Best Supportive Care control group. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Evaluate the time-to-progression of subjects treated with Lucanix™ compared to treatment within the Best Supportive Care control group. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Evaluate the best overall tumor response in subjects treated with Lucanix™ compared to treatment in the Best Supportive Care control group. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Evaluate the response duration in subjects treated with Lucanix™ compared to the Best Supportive Care control group. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Evaluate the rate of CNS metastases development in subjects treated with Lucanix™ as compared to the Best Supportive Care control group. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Adverse events of subjects treated with Lucanix™ will be compared to subjects in the Best Supportive Care control group. [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	700
Study Start Date:	July 2008
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment: Experimental Treatment Arm: This course of therapy is Best Support Care (BSC) plus monthly intradermal (ID) injections of Lucanix™ (belagenpumatucel-L) consisting of 25,000,000 cells in a volume of 0.40 mL.	Biological: Lucanix™ Treatment Arm: Subjects receive Lucanix™ (belagenpumatucel-L) intradermally (ID) once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.
Control Arm: Placebo Comparator Control Arm: This course of therapy is Best Support Care (BSC) plus a placebo injection that consists of 0.15% Intralipid® in solution composed of the cryopreservation formulation minus the gene modified cells and dimethyl sulfoxide (DMSO) in a volume of 0.40 mL.	Other: Placebo Comparator Control Arm: Subjects receive placebo ID once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.

Detailed Description:

Primary Efficacy Endpoints:

Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix™) vs placebo.

Secondary Efficacy Endpoints:

Evaluate the progression free survival (PFS) of subjects treated with Lucanix™ compared to treatment within the BSC control group.
Evaluate the quality of life (QOL) as determined by the Lung Cancer Symptom Scale (LCSS) compared to treatment within the BSC control group.
Evaluate the time-to-progression of subjects treated with Lucanix™ compared to treatment within the BSC control group.
Evaluate the best overall tumor response in subjects treated with Lucanix™ compared to treatment in the BSC control group.
Evaluate the response duration in subjects treated with Lucanix™ compared to the BSC control group.
Evaluate the rate of CNS metastases development in subjects treated with Lucanix™ as compared to the BSC control group.
Adverse events of subjects treated with Lucanix™ will be compared to subjects in the control group.

Outline: This is a multicenter study. Subjects are stratified according to disease stage (IIIA vs IIIB or IV), response to prior treatment with front-line chemotherapy (stable disease vs partial response or complete response), prior treatment with front-line chemotherapy and radiotherapy (front-line chemotherapy with radiotherapy vs front-line chemotherapy alone), and prior treatment with front-line chemotherapy and other anticancer therapy (front-line chemotherapy with bevacizumab vs front-line chemotherapy alone or in combination with another anticancer agent). Subjects are randomized to 1 of 2 treatment arms.

Treatment Arm: Subjects receive belagenpumatucel-L (Lucanix™) intradermally (ID) once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.
Control Arm: Subjects receive placebo ID once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.

Blood samples are collected and analyzed for routine chemistry, cytokines, chemokines, and some instances circulating tumor cells, including response to multiple lung cancer-associated antigens by IFN-γ ELISPOT CD8+ assay; CEA by CD4 class II assay; lung tumor-associated antigens by in vitro proliferation assays; regulatory T-cell (Treg) phenotype by flow cytometry; and Treg function.

Subjects complete the Lung Cancer Symptom Scale quality of life questionnaire at baseline, on the days of treatment, 30 days after completion of study treatment, and then every 3 months for 1 year.

After completion of study treatment, subjects are followed every 3 months for 1 year and then annually for 4 years.

In two phase II trials, many subjects who received Lucanix™ at the same dose that will be administered in this trial had long-term disease stability with a good quality of life.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with histologically or cytologically confirmed NSCLC who meet one of the following staging requirements:
Stage IIIA (T3N2 only) or
Stage IIIB or
Stage IV.
Subjects must have stable disease (SD) or an objective response (PR or CR) to a prior single, frontline, platinum-based chemotherapy regimen (additional prior adjuvant chemotherapy is permitted) consisting of up to six (6) treatment cycles with or without concomitant radiation therapy.
Not less than four weeks nor more than four months must have elapsed since the completion of the last chemotherapy cycle and registration into the study.
Subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
Signed informed consent.
Not less than 18 years and not more than 75 years old.
Estimated life expectancy of at least 12 weeks.
Performance status (ECOG) ≤ 2.
Absolute neutrophil count ≥ 1,500/mm3.
Hemoglobin ≥ 9 g/dL.
Platelet count ≥ 100,000/mm3.
Albumin levels ≥ 2.5 g/dL.
Bilirubin ≤ 1.5 times the upper limit of normal (ULN).
Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 1.5 × ULN.
Creatinine ≤ 1.5 × ULN.
Alkaline phosphatase ≤ 5 × ULN.

Exclusion Criteria:

Concurrent systemic steroids > 2 mg /day prednisone (or prednisone-equivalent of prednisolone or dexamethasone).
Prior splenectomy.
Any surgery involving general anesthesia < 4 weeks prior to study registration.
Chemotherapy more than 4 months or less than 4 weeks prior to study registration.
Steroid therapy (excluding ≤ 2 mg/day prednisone or prednisone-equivalent of prednisolone or dexamethasone), radiation therapy, or immunotherapy less than 4 weeks prior to study registration.
Subjects with documented active brain metastasis(es) at the time of study entry are ineligible. However, subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
Painful bone metastases, or bone metastases that require immediate therapy.
Significant and/or symptomatic pleural effusions. Presence of clinically detectable (by physical exam) third-space fluid collections, for example, pleural effusions that cannot be controlled by previous chemotherapy and/or drainage, or other procedures, prior to study entry.
Known allergies to eggs or soy.
Significant weight loss (≥ 10% body weight in preceding 6 weeks).
Known HIV positivity (EBV origin of replication in the pCHEK/HBA2 vector used to modify the vaccine components can trans-activate HIV).
Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections) or other conditions that, in the opinion of the investigator, would compromise study objectives.
NCI CTC Grade 3 or 4 peripheral neuropathy at study registration.
Prior other malignancies (excluding non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years.
History of psychiatric disorder that would impede ability to give informed consent or adherence to study requirements.
Pregnant or nursing women, or refusal to practice contraception if of reproductive potential.
Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
Known active Epstein-Barr infection within ≤ 60 days of study registration.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676507

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Locations

United States, Alabama
Southern Cancer Center	Recruiting
Mobile, Alabama, United States, 36608
Contact: Amber Davis 251-631-3541 amber.davis@southerncancercenter.com
Principal Investigator: Jeffrey R George, MD
United States, Arizona
Mayo Clinic Cancer Center	Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Tracy Keller, RN BSN 480-301-6767 keller.tracy@mayo.edu
Principal Investigator: Helen Ross, MD
United States, Arkansas
Clopton Clinic Hematology/Oncology	Recruiting
Jonesboro, Arkansas, United States, 72401
Contact: Amber Moon, RN, OCN 870-910-7723 amber.moon@cloptonclinic.com
Principal Investigator: Marc Monte, MD
United States, California
Comprehensive Blood and Cancer Center	Recruiting
Bakersfield, California, United States, 93309
Contact: Gloria Swartz 661-322-2206 gswartz@cbccusa.com
Principal Investigator: Ravi Patel, MD
University of California, San Diego	Recruiting
La Jolla, California, United States, 92093
Contact: Kelly Souder 858-822-7952 knsouder@ucsd.edu
Principal Investigator: Lyudmila Bazhenova, MD
Cancer Care Associates	Recruiting
Redondo, California, United States, 90277
Contact: Sherry Hutcherson 310-750-3376 shutcherson@mednet.ucla.edu
Principal Investigator: David Chan, MD
Santa Barbara Hematology Oncology Medical Group, Inc.	Recruiting
Santa Barbara, California, United States, 93105
Contact: Kelly Fernandez 808-898-2192 kelly@ccsb.org
Principal Investigator: Fred Kass, MD
Sansum Clinic	Recruiting
Santa Barbara, California, United States, 93105
Contact: Kelly Fernandez 805-898-2192 kelly@ccsb.org
Principal Investigator: Julie Taguchi, MD
Central Coast Medical Oncology Corporation	Recruiting
Santa Maria, California, United States, 93454
Contact: Alison Fernandez, RN 805-739-3724 Alison.Fernandez@chw.edu
Principal Investigator: Brian DiCarlo, MD
United States, Colorado
University of Colorado Health Science Center	Recruiting
Aurora, Colorado, United States, 80045
Contact: Janice Littieri 720-848-0628 janice.lettieri@ucdenver.edu
Principal Investigator: Ana Oton, MD
St. Mary's Hospital Regional Cancer Center	Recruiting
Grand Junction, Colorado, United States, 81501
Contact: Mary L. Vaughn, RN, BSN, CCRP 970-244-7164 Mary.Vaughn@stmarygj.org
Principal Investigator: Diane Melancon, MD
United States, Florida
Pasco Hernando Oncology Associates, P.A.	Recruiting
Brooksville, Florida, United States, 34613
Contact: Kim Graves, RN 352-596-1401 ext 218 kgraves@phoa4.com
Principal Investigator: Raju Rao, MD
Ocala Oncology	Recruiting
Ocala, Florida, United States, 34471
Contact: Amy Liebmann 352-732-0874 amy.liebmann@usoncology.com
Principal Investigator: Craig Reynolds, MD
United States, Georgia
Atlanta Cancer Care	Recruiting
Roswell, Georgia, United States, 30076
Contact: Julie Carney, RN 678-287-1241 jcarney@atlantacancercare.com
Principal Investigator: Ronald Steis, MD
United States, Idaho
Kootenai Cancer Center	Recruiting
Post Falls, Idaho, United States, 83854
Contact: Sheryl Golden, RN, MSN, OCN 208-619-4151 sgolden@kmc.org
Principal Investigator: Haluk Tezcan, MD
United States, Illinois
Warren Billhartz Cancer Center	Recruiting
Maryville, Illinois, United States, 62062
Contact: Wendy McIntyre 618-391-5900 mcintyrew@andersonhospital.org
Principal Investigator: John Visconti, MD
United States, Indiana
St. Francis Cancer Research Foundation	Recruiting
Beech Grove, Indiana, United States, 46107
Contact: Debrta Duvall, RN 317-735-4481 debra.duvall@ssfhs.org
Principal Investigator: Michael Slaughter, MD
Providence Medical Group	Recruiting
Terre Haute, Indiana, United States, 47802
Contact: Kim Villain, RN, OCN 812-232-1418 kvillain@provmed.net
Principal Investigator: Sang Huh, MD
United States, Iowa
McFarland Clinic, P.C.	Recruiting
Ames, Iowa, United States, 50010-3014
Contact: Janet Mannetter, RN, BSN, CCRP 515-239-2621 mannetter@mgmc.com
Principal Investigator: Debra Prow, MD
Iowa Blood and Cancer Center	Recruiting
Cedar Rapids, Iowa, United States, 52402
Contact: Carlene Etscheidt, RN 319-369-7091 cetscheidt@ibacc.org
Principal Investigator: David W. Zenk, MD
United States, Louisiana
Hematology Oncology Life Center	Recruiting
Alexandria, Louisiana, United States, 71301
Contact: Carla Ouber, RN 318-442-2232 ext 3068 research@holcmed.com
Principal Investigator: Howard Wold, MD
United States, Maryland
National Cancer Institute Center for Cancer Research, Medical Oncology Branch	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Corrine M Keen, RN, MS, OCN 301-496-3778 ckeen@mail.nih.gov
Principal Investigator: Giuseppe Giaccone, MD, PhD
United States, Michigan
Henry Ford Health System	Recruiting
Detroit, Michigan, United States, 48202
Contact: Tiffany Pierce 313-916-1784 tpearce1@hfhs.org
Principal Investigator: Haythem Ali, MD
United States, Minnesota
University of Minnesota Medical Center	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Debra Herzan, RN, BSN, OCN 612-626-4495 herza001@umn.edu
Principal Investigator: Arkadiusz Dudek, MD, PhD
Mayo Clinic Cancer Center	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Angie Meilander 507-284-2030 meilander.angela@mayo.edu
Principal Investigator: Julian R. Molina, MD
United States, Nevada
Comprehensive Cancer Centers of Nevada	Recruiting
Henderson, Nevada, United States, 89052
Contact: Donna Katz 702-952-2084 donnakatz@mednet.ucla.edu
Principal Investigator: Rupesh Parikh, MD
United States, New Jersey
Hackensack University Medical Center	Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Diane Denbleyker 201-996-5086 ddenbleyker@humed.com
Principal Investigator: Harry Harper, MD
United States, New York
Eastchester Center for Cancer Care	Recruiting
Bronx, New York, United States, 10469
Contact: Karen Hoffman, MD 718-732-4029 karen@eastchestercenter.com
Principal Investigator: Fabio Volterra, MD
Richmond University Medical Center	Recruiting
Staten Island, New York, United States, 10310
Contact: Marion Smith, RN, MS, OCN 718-808-1063 marismith@rumcsi.org
Principal Investigator: Thomas J Forlenza, MD
United States, North Carolina
Cancer Care of WNC	Recruiting
Asheville, North Carolina, United States, 28801
Contact: Candace Cox 828-253-4262 candace@cancercareofwnc.com
Principal Investigator: Christopher Chay, MD
Carolina BioOncology Institute	Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Jahleen Byers 704-947-6599 jbyers@carolinabiooncology.org
Principal Investigator: John Powderly, II, MD
United States, Ohio
Gabrail Cancer Center Research LLC	Recruiting
Canton, Ohio, United States, 44718
Contact: Carrie Smith, RN 330-492-3345 csmith@gabrailcancercenter.com
Principal Investigator: Neshat Gabrail, MD
Tri-County Hematology and Oncology Associates, Inc.	Recruiting
Canton, Ohio, United States, 44718
Contact: Kim Mayle 330-588-4588 kim.mayle@cantonmercy.org
Principal Investigator: Farouq Ahmed, MD
United States, South Carolina
Cancer Center of the Carolinas	Recruiting
Greenville, South Carolina, United States, 29605
Contact: Lisa Johnson, RN, BSN 864-679-3966 lisa.johnson@usoncology.com
Principal Investigator: Joe Stephenson, MD
Coastal Cancer Center	Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Carla Gatti 843-429-5042 clinicaltrials@coastalcancercenter.com
Principal Investigator: Lawrence B. Holt, MD FACP
United States, Tennessee
University of Tennessee Cancer Institute	Recruiting
Memphis, Tennessee, United States, 38104
Contact: Jamie Wood 901-383-5570 ext 1148 jwood@utcancer.com
Principal Investigator: Raymond Osarogiagbon, MD
United States, Texas
Texas Cancer Center Abilene, Texas Oncology P.A.	Recruiting
Abilene, Texas, United States, 79606
Contact: Tammie Coffman, RN 325-692-0188 tammie.coffman@usoncology.com
Principal Investigator: Anton Melnyk, MD
Mary Crowley Cancer Research Centers	Recruiting
Dallas, Texas, United States, 75246
Contact: Kay Easterwood-Sanchez 214-658-1943 keasterwoodsanchez@marycrowley.org
Principal Investigator: John J. Nemunaitis, MD
Allison Cancer Center, Texas Oncology, P.A.	Recruiting
Midland, Texas, United States, 79701
Contact: Sarah Turner, BS 432-686-5715 sara.turner@usoncology.com
Principal Investigator: David Watkins, MD
Tyler Cancer Center, Texas Oncology	Recruiting
Tyler, Texas, United States, 75702
Contact: Linda Dunklin, RN, OCN 903-579-9867 linda.dunklin@usoncology.com
Principal Investigator: Donald A Richards, MD
United States, Washington
Seattle Cancer Care Alliance/Fred Hutchinson Cancer Res Ctr/Univ. of Washington Med Ctr	Recruiting
Seattle, Washington, United States, 98109
Contact: Kari Stricker 206-288-7481 kstricke@uw.edu
Principal Investigator: Keith D. Eaton, MD, PhD
United States, West Virginia
Davis Memorial Cancer Center	Recruiting
Elkins, West Virginia, United States, 26241
Contact: Linda Zirbs 304-637-3644 ZirbsL@davishealthsystem.org
Principal Investigator: Donald R Fleming, MD
United States, Wisconsin
Marshfield Clinic Weston Center	Recruiting
Weston, Wisconsin, United States, 54476
Contact: Lyn Stephani 715-387-9316 stephani.lynda@marshfieldclinic.org
Principal Investigator: Adedayo Onitilo, MD
Canada, Alberta
University of Alberta Cross Cancer Institute	Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Romeo Felix, RN 780-577-8048 romeofel@cancerboard.ab.ca
Principal Investigator: Quincy S-C Chu, MD
Canada, Ontario
Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Dianne Zawisza 416-946-2913 dianne.zawisza@uhn.on.ca
Principal Investigator: Natasha Leighl, MD
Hungary
Országos Korányi TBC és Pulmonológiai Intézet	Recruiting
Budapest, Hungary, 1529
Contact: Barna Tímea +36 1 391 3277 timeabarna@freemail.hu
Principal Investigator: Erzsébet Juhász, MD
Semmelweis Egyetem Pulmonológiai Klinika	Recruiting
Budapest, Hungary, 1125
Contact: Gabriella Zahorecz +36-1-355-9733 zahoreczg@freemail.hu
Principal Investigator: György Losonczy, MD
Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza	Recruiting
Deszk, Hungary, 6772
Contact: Wentné Rádin Ruzsica +36 62 571 512 titkarsag@deszkikorhaz.hu
Principal Investigator: Beatrix Bálint, MD
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórháza	Recruiting
Nyíregyháza, Hungary, 4412
Contact: Ildiko Madai +36-20-316-9483 pulmo1@josa.hu
Principal Investigator: Ilona Vinkler, MD
Fejér Megyei Szent György Kórház	Recruiting
Székesfehérvár, Hungary, 8000
Contact: Gábor Grmela +36-20-823-6496 ggrmela@mail.fmkorhaz.hu
Principal Investigator: Zsolt Pápai-Székely, MD
Pest Megyei Tüdőgyógyintézet	Recruiting
Törökbálint, Hungary, 2045
Contact: Kovács Katalin +36 23 511 562 orvosigazgato@tbti.t-online.hu
Principal Investigator: Edina Tolnay, MD
India
Gujarat Cancer Hospital and Research Institute	Recruiting
Ahmedabad, India, 380016
Contact: Harsha Panchal, MD + 91 9825940769 drharshapanchal@hotmail.com
Principal Investigator: Harsha Panchal, MD
Apollo Hospitals	Recruiting
Hyderabad, India, 500033
Contact: Srinivas Chakravarthy Gummaraju, MD + 91 9989299091 hydaherf@gmail.com
Principal Investigator: Srinivas Chakravarthy Gummaraju, MD
SEAROC Cancer Center, S.K.	Recruiting
Jaipur, India, 302013
Contact: Anish Maru, MD + 91 9829060128 anishmaru@yahoo.com
Principal Investigator: Ansih Maru, MD
Tata Memorial Hospital	Recruiting
Mumbai, India, 400012
Contact: Prabhash Kumar, MD + 91 9224182898 kp_prabhash@rediffmail.com
Principal Investigator: Prabhash Kumar, MD
Regional Cancer Centre	Recruiting
Trivandrum, India, 695011
Contact: Sivanandan Choondal Devan, MD + 91 9447882149 sivanandancd@hotmail.com
Principal Investigator: Sivanandan Choondal Devan, MD
Poland
Akademickie Centrum Kliniczne Szpital Akademii Medycznej w Gdansku	Recruiting
Gdansk, Poland, 80 952
Contact: Jacek Jassem, M.D., Ph. D. 48583492270 jjassem@gumed.edu.pl
Principal Investigator: Jacek Jassem, M.D., Ph. D.
Akademickie Centrum Kliniczne Szpital Akademii Medycznej w Gdansku	Recruiting
Gdansk, Poland, 80-952
Contact: Agnieszka Pliszka +48-583-492-973 pliszka@gumed.edu.pl
Principal Investigator: Jacek Jassem, MD
NZOZ Vesalius Sp z oo	Recruiting
Krakow, Poland, 31-108
Contact: Piotr Koralewski, M.D., Ph.D. 48126468781 piotr.koralewski@interia.pl
Principal Investigator: Piotr Koralewski, M.D., Ph. D.
Samodzielny Publiczny Szpital Kliniczny nr 4	Recruiting
Lublin, Poland, 20-954
Contact: Joanna Smarz +48-817-244-431 pulmdept@am.lublin.pl
Principal Investigator: Janusz Milanowski, MD
Samodzielny Publiczny Szpital Kliniczny nr 4	Recruiting
Lublin, Poland, 20-954
Contact: Janusz Milanowski, M.D., Ph.D 48817244839 pulm.dept@am.lublin.pl
Principal Investigator: Janusz Milanowski, M.D., Ph.D
Wielkopolskie Centrum Pulmunologii i Torakochirurgii	Not yet recruiting
Poznan, Poland, 60-569
Contact: Marzena Misiaczyk +48-502-733-582 marzenamisiaczyk@poczta.onet.pl
Principal Investigator: Rodryg Ramlau, MD
Wielkopolskie Centrum Pulmunologii i Torakochirurgii	Recruiting
Poznan, Poland, 60-569
Contact: Rodryg Ramlau, MD 48616654244 rramlau@onet.eu
Principal Investigator: Rodryg Ramlau, MD
Centrum Onkologii - Instytut im.Marii Sklodowskiej-Curie	Recruiting
Warsaw, Poland, 02-784
Contact: Malgorzata Kozlik +48-225-463-066 kozlikm@coi.waw.pl
Principal Investigator: Maciej Krzakowski, MD
Centrum Onkologii - Instytut im.Marii Sklodowskiej-Curie	Recruiting
Warsaw, Poland, 02-784
Contact: Maciej Krzakowski, M.D., Ph. D. 48226447625 maciekk@coi.waw.pt
Principal Investigator: Maciej Krzakowski, M.D., Ph. D.
Serbia
Klinicko-bolnicki centar Bezanijska kosa	Recruiting
Belgrade, Serbia, 11000
Contact: Danka Kavurin +381 64 2631263
Principal Investigator: Vladimir Kovcin, MD
Klinicki Centar Nis	Recruiting
Nis, Serbia, 18000
Contact: Marina Cekic, MD +381 64 1118223 Marina.cekic@gmail.com
Principal Investigator: Milan Rancic, MD
Institute for pulmonary disease Sremska Kamenica	Recruiting
Sremska Kamenica, Serbia, 21204
Contact: Daliborka Bursac, MD +381 64 2839713 Jelena_bb@neobee.net
Principal Investigator: Nevena Secen, MD
United Kingdom
Clatterbridge Centre for Oncology	Recruiting
Bebington, Wirral, United Kingdom, CH63 4JY
Contact: Joanne Upton +44-151-334-1155 ext 5731 joanne.upton@ccotrust.nhs.uk
Principal Investigator: Ernest Marshall, MD
Ninewells Hospital and Medical School	Recruiting
Dundee, United Kingdom, DD1 9SY
Contact: Debbie Forbes +44-1382-660-111 debbieforbes@nhs.net
Principal Investigator: Elaine Rankin, MD
Glasgow Royal Infirmary	Recruiting
Glasgow, United Kingdom, G12 0YN
Contact: Calum Innes +44-141-301-7224 calum.ines@northglasgow.scot.nhs.uk
Principal Investigator: David Dunlop, MD
Guy's Hospital	Recruiting
London, United Kingdom, SE1 9RT
Contact: Sharon Delena +44-207-188-2006 ext 87752 sharon.delena@gstt.nhs.uk
Principal Investigator: Rohit Lal, MD

Sponsors and Collaborators

NovaRx Corporation

Responsible Party:	NovaRx Corporation ( Habib Fakhrai, Ph.D., President & Executive Vice Chairman )
ClinicalTrials.gov Identifier:	NCT00676507 History of Changes
Obsolete Identifiers:	NCT00641966
Other Study ID Numbers:	NR001-03, BB-IND 8868
Study First Received:	May 8, 2008
Last Updated:	August 6, 2010
Health Authority:	United States: Food and Drug Administration; Italy: National Institute of Health; United States: Institutional Review Board; Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Paul-Ehrlich-Institut; Poland: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Hungary: National Institute of Pharmacy; Italy: Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; India: Central Drugs Standard Control Organization