Study for Women With Platinum Resistant Ovarian Cancer Evaluating EC145 in Combination With Doxil® (PROCEED)

This study is currently recruiting participants.
Verified April 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01170650
First received: July 7, 2010
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to compare progression-free survival (PFS) (based upon investigator assessment using RECIST v1.1) in participants with platinum-resistant ovarian cancer who receive combination therapy with EC145 and pegylated liposomal doxorubicin (EC145+PLD) with that in participants who receive PLD and placebo.


Condition Intervention Phase
Ovarian Cancer
Drug: EC145
Drug: Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®)
Drug: placebo
Drug: EC20
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Phase 3 Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®) in Combination Versus PLD in Participants With Platinum-Resistant Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Progression-free survival based on investigator assessment using RECIST v1.1. [ Time Frame: up to 26 months ] [ Designated as safety issue: No ]
    Progression is assessed at 6 week intervals through Week 24 and at 8 week intervals thereafter.


Secondary Outcome Measures:
  • Compare overall survival of participants between treatment arms. [ Time Frame: Approximately 20 months after last patient randomized ] [ Designated as safety issue: No ]
    OS analysis will occur when 384 deaths have occurred.

  • Incidence of Adverse Events, Serious Adverse Events, and Deaths. [ Time Frame: up to 26 months ] [ Designated as safety issue: Yes ]
    Adverse events (as a measure of safety and tolerability) will be assessed at each study visit.


Estimated Enrollment: 640
Study Start Date: April 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
EC145 + Pegylated Liposomal Doxorubicin (PLD)
Drug: EC145
IV bolus on days 1,3,5 and 15,17,19 of a 4-week cycle
Drug: Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®)
50 mg/m2 (calculated on the basis of ideal body weight) every 4 weeks. Dose reductions permitted for toxicity.
Other Names:
  • Doxil
  • Caelyx
Drug: EC20
During the screening period participants will receive a single intravenous administration of EC20 prior to SPECT imaging
Active Comparator: Arm B
placebo + Pegylated Liposomal Doxorubicin (PLD)
Drug: Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®)
50 mg/m2 (calculated on the basis of ideal body weight) every 4 weeks. Dose reductions permitted for toxicity.
Other Names:
  • Doxil
  • Caelyx
Drug: placebo
IV bolus on days 1,3,5 and 15,17,19 of a 4-week cycle
Drug: EC20
During the screening period participants will receive a single intravenous administration of EC20 prior to SPECT imaging

Detailed Description:

This is a Phase 3 clinical trial to evaluate the efficacy and safety of the combination of EC145 and pegylated liposomal doxorubicin (PLD; available in the United States as Doxil® and outside the United States as Caelyx®) compared to PLD and placebo. Enrollment of 640 patients including approximately 500 that are folate receptor positive is planned.

EC145 is a drug that is specifically designed to enter cancer cells via the folate vitamin receptor (FR) that is not generally found on normal cells. Experimental evidence shows that this target receptor is expressed on virtually all ovarian cancers. Early clinical evidence in a small number of Phase I participants, in a subset of participants in a completed single-arm Phase II study, and interim data from an ongoing randomized Phase 2 study (PRECEDENT) suggests that EC145 may have antitumor effect in women with platinum-resistant ovarian cancer and that EC145 alone and in combination with PLD is generally well-tolerated. This evidence suggests that EC145 may be useful as chemotherapy against platinum-resistant ovarian cancer.

All participants will undergo imaging with the FR-targeting investigational diagnostic agent EC20 during the screening period to assess binding of the imaging agent EC20 to tumors. This non-invasive procedure will provide additional information on the utility of using EC20 imaging to identify subjects with the FR molecular "target" prior to treatment with EC145 therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must sign an approved informed consent form (ICF).
  • Participants must be ≥ 18 years of age.
  • Participants must have pathology-confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
  • Participants must have primary or secondary platinum-resistant ovarian cancer.
  • Participants must have at least a single (RECIST v1.1-defined) measurable lesion.
  • For the purpose of obtaining a RECIST v1.1 baseline scan, participants must have a radiological evaluation conducted no more than 28 days prior to beginning study therapy (PLD). NOTE: For participants with a history of CNS metastasis, baseline radiological imaging must include an evaluation of the head.
  • Participants must have had prior debulking surgery.
  • Participants must have received prior platinum-based chemotherapy for management of primary disease but must not have received more than 2 prior systemic cytotoxic regimens.
  • Participants are allowed to have received, but are not required to have received, one additional non-cytotoxic antitumor agent (eg, biologic or cytostatic) for the management of ovarian cancer.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Participants must have recovered (to baseline/stabilization) from prior cytotoxic therapy-associated acute toxicities.
  • Participants must have adequate organ function including:

    1. Bone Marrow Reserve:

      1. Absolute neutrophil count (ANC) ≥ 1.5x10^9/L prior to treatment. Participants on maintenance doses of granulocyte colony stimulating factor (G-CSF) are eligible.
      2. Platelets ≥ 100x10^9/L
      3. Hemoglobin ≥ 9 g/dL
      4. Use of supportive care measures (eg, use of white blood cell [WBC] growth factors, antiemetics, epoetin) should follow the ASCO guidelines as listed at www.asco.org. Participants should receive full supportive care, including transfusion of blood as mandated by clinical need; however, transfusions administered for the sole purpose of meeting the study inclusion criteria between the time informed consent is signed and first dose of EC145/placebo/PLD is administered are not allowed.
    2. Hepatic: Total bilirubin level < 1.5 x ULN and ALT, AST, GGT, and alkaline phosphatase levels < 2.5 x ULN.
    3. Renal: Serum creatinine level ≤ 1.5 x ULN or for participants with serum creatinine levels above 1.5 x ULN, creatinine clearance ≥ 50 mL/min/1.73m^2
    4. Cardiac: Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal.

Exclusion Criteria:

  • Patients refractory to primary platinum therapy where "refactory" is defined as disease progression within 6 months of first dose of initial platinum-based therapy.
  • Diagnosis of "tumor of low-malignant potential".
  • Prior exposure to PLD or anthracycline therapy.
  • Prior exposure to FR-targeted therapy (eg, EC145, EC0225, EC0489, farletuzumab).
  • Prior therapy with vinorelbine (Navelbine®) or vinca-containing compounds.
  • Prior abdominal or pelvic radiation therapy or radiation therapy to > 10% of the bone marrow at any time in the past or prior radiation therapy within the past 3 years to the breast/sternum, dermal lesions, head or neck.
  • Recent (i.e., ≤ 6 weeks) history of abdominal surgery or peritonitis
  • Serious comorbidities (as determined by the investigator) such as, but not limited to, active congestive heart failure or recent myocardial infarction. Patients who require antifolate therapy for the management of comorbid conditions (e.g., rheumatoid arthritis) will be excluded from the trial.
  • Pregnant or nursing.
  • Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
  • Symptomatic central nervous system (CNS) metastasis.
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). Use of low dose corticosteroid therapy (e.g., for nausea prophylaxis) is acceptable; however, concomitant tamoxifen therapy is not. Supportive care measures are allowed.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170650

Contacts
Contact: Toll Free Number 18885778839

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Heidi Kogut    480-301-4976    kogut.heidi@mayo.edu   
Principal Investigator: Nina Karlin, MD         
University of Arizona - Arizona Cancer Center Recruiting
Tuscon, Arizona, United States, 85724
Contact: Missy Driggers    520-321-7798 ext 41    jdriggers@azcc.arizona.edu   
Principal Investigator: Setsuko Chambers, MD         
United States, California
North American Research Institute Active, not recruiting
Azusa, California, United States, 91773
Providence Saint Joseph Medical Center Recruiting
Burbank, California, United States, 91505
Contact: Veronica Hudson    818-847-3219    veronica.hudson@providence.org   
Principal Investigator: Peter Rosen, MD         
Marin Caner Care, Inc. Recruiting
Greenbrae, California, United States, 94904
Contact: Jaime Chang    415-925-5040    jchang@marincancercare.com   
Principal Investigator: Peter Eisenberg, MD         
Moores UCSD Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Ashley Tydon    858-822-5378    atydon@ucsd.edu   
Principal Investigator: Stephen Plaxe, MD         
Scripps Clinical Research Services Withdrawn
La Jolla, California, United States, 92037
Kaiser Permanente Medical Center Recruiting
Los Angeles, California, United States, 90027
Contact: Rose Punzalan-Carlos    323-783-8741    rose.a.punzalan-carlos@kp.org   
Principal Investigator: Steven Vasilev, MD         
UCI Medical Center Not yet recruiting
Orange, California, United States, 92868
Contact: Anita Wallick    714-456-7400    awallick@uci.edu   
Principal Investigator: Krishnansu Tewari         
PMK Medical Group, Inc., dba Ventura County Hematology Oncology Specialists Recruiting
Oxnard, California, United States, 93030
Contact: Manuel Marquez    805-485-8709 ext 129    mmarquez@venturaoncology.com   
Principal Investigator: Ann S Kelley, MD         
Oncology Associates of San Diego Recruiting
San Diego, California, United States, 92123
Contact: Cathy Wood    858-939-5062    cathy.wood@sharp.com   
Principal Investigator: Jennifer Fisher, MD         
North American Research Institute Recruiting
San Dimas, California, United States, 91970
Contact: Jenny Nyguyn    909-994-5822    Jenny.nari@sbcglobal.net   
Principal Investigator: Brian LeBerthon, MD         
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Brenda Eng    415-600-1775    engb@cpmcri.org   
Principal Investigator: Ari Baron, MD         
University of California, San Francisco Not yet recruiting
San Francisco, California, United States, 94115
Contact: Lilian Hu    415-885-7206    hull@obgyn.ucsf.edu   
Principal Investigator: Rebecca Brooks, MD         
Stanford University Medical Center - Cancer Center Recruiting
Standford, California, United States, 94305
Contact: Maureen Sutton    650-725-9167    mbsutton@stanford.edu   
Principal Investigator: Jonathon Berek, MD         
Kaiser Permanente Vallejo Medical Center Withdrawn
Vallejo, California, United States, 94589
United States, Connecticut
St. Vincent's Medcial Center Recruiting
Bridgeport, Connecticut, United States, 06606
Contact: Teresa White    203-576-6329    twhite@stvincents.org   
Principal Investigator: Paul Berard, MD         
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Lisa Baker    203-785-6398    lisa.baker@yale.edu   
Principal Investigator: Thomas Rutherford, MD         
United States, Florida
Altus Research Recruiting
Hollywood, Florida, United States, 33021
Contact: Gisela Pereira    954-602-9723    gpereira@altusresearch.com   
Principal Investigator: Jacob Tangir, MD         
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Carolyn Bieber    904-953-6824    bieber.carolyn@mayo.edu   
Principal Investigator: Candido Riveria, MD         
Cancer and Blood Disease Center Recruiting
Lecanto, Florida, United States, 34461
Contact: Linda Kruleski    352-746-0707    lktrials@tampabay.rr.com   
Principal Investigator: Gustavo Fonseca, MD         
Gynecologic Oncology Associates, Inc Recruiting
Miramar, Florida, United States, 33029
Contact: Tracy Rodriguez    954-294-3578    trodriguez@shcr.com   
Principal Investigator: Karen Nishida, MD         
Florida Hospital Cancer Institute Recruiting
Orlando, Florida, United States, 32804
Contact: Jane Crofton    407-303-2091    Jane.Crofton@flhosp.org   
Principal Investigator: Robert Holloway         
Palm Beach Cancer Institute - Palm Beach Cancer Institute Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Karen Minder    561-366-4128    karen.minder@pbcancer.com   
Principal Investigator: Daniel Spitz, MD         
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Judith Robinson    404-303-3926    judith.robinson@northside.com   
Principal Investigator: Benedict Benigno, MD         
Medical College of Georgia Recruiting
Augusta, Georgia, United States, 30912
Contact: Sara Mobley    706-721-4805    smobley@georgiahealth.edu   
Principal Investigator: Sharad Ghamande         
Southeastern Gynecologic Oncology Recruiting
Gainesville, Georgia, United States, 30501
Contact: Trena Davis    770-219-8822    trena.davis@nghs.com   
Principal Investigator: Andrew Green, MD         
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: Joni Shortt    912-350-8913    Shortjo1@memorialhealth.com   
Principal Investigator: James Burke, II, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Carolyn Passaglia    312-472-5725    c-passaglia@northwestern.edu   
Principal Investigator: Julian Schink, MD         
Decatur Memorial Hospital Withdrawn
Decatur, Illinois, United States, 62526
Sudarshan K. Sharma, LTD Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Peg Gregus    630-856-6757    peggregus@yahoo.com   
Principal Investigator: Sudarshan Sharma, MD         
United States, Indiana
St. Vincent Gynecologic Oncology Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Sue Rivers    317-415-6745    SMRivers@stvincent.org   
Principal Investigator: Greg Sutton, MD         
St. Francis Medical Group Gynecologic Oncology of Indiana Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Debra Duvall    317-735-4481    Debra.Duvall@ssfhs.org   
Principal Investigator: David Moore, MD         
Horizon Oncology Center Recruiting
Lafayette, Indiana, United States, 47905
Contact: Michelle Hamm    765-446-5111    Mhamm3@iuhealth.org   
Principal Investigator: Wael Harb, MD         
Northern Indiana Cancer Research Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact: Lori Wiseman    574-647-6821    lwiseman@memorialsb.org   
Principal Investigator: Michael Method, MD         
United States, Kentucky
University of Louisville James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Kaleigh Coughlin    502-562-4006    kacoug02@gwise.louisville.edu   
Principal Investigator: Lynn Parker, MD         
United States, Louisiana
Ochsner Clinic Foundation Withdrawn
New Orleans, Louisiana, United States, 70121
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Michele Besche    410-328-8610    mbesche@umm.edu   
Principal Investigator: Sarah Temkin, MD         
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Judy Bosley    410-601-6120    jbosley@lifebridgehealth.org   
Principal Investigator: Mark Miller, MD         
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Recruiting
Baltimore, Maryland, United States, 21237
Contact: Jean Flack    443-777-7364    jean.flack@medstar.net   
Principal Investigator: Pallavi Kumar         
Center for Blood and Cancer Disorders Recruiting
Bethesda, Maryland, United States, 20817
Contact: Natalie Bongiorno    301-571-2016    nbongiorno@ccbdmd.com   
Principal Investigator: Ralph Boccia, MD         
Meritus Center for Clinical Research Recruiting
Hagerstown, Maryland, United States, 21742
Contact: Kathleen Renee    301-790-8598    kathleen.renee@meritushealth.com   
Principal Investigator: Michael McCormack, MD         
Peninsula Regional Medical Center Recruiting
Salisbury, Maryland, United States, 21801
Contact: Sandra Heineken    410-543-7017    sandra.heineken@peninsula.org   
Principal Investigator: Paul E Zorsky, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Rochelle Williams-Belizaire    617-724-3858    RWILLIAMS0@PARTNERS.ORG   
Principal Investigator: Richard Penson, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Kendra Demakis    617-667-5987    kdemakis@bidmc.harvard.edu   
Principal Investigator: Panagiotis Konstantinopoulos, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02114
Contact: Christine Lundquist    617-632-5839    clundquist@partners.org   
Principal Investigator: Ursala Matulonis, MD         
United States, Michigan
Bay Regional Medical center Withdrawn
Bay City, Michigan, United States, 48706
Karmanos Cancer Center Recruiting
Detroit, Michigan, United States, 48201
Contact: Ann Ferris    313-576-9386    ferrisa@karmanos.org   
Principal Investigator: Robert Morris, MD         
Singh & Arora Onc/Hem, PC Not yet recruiting
Flint, Michigan, United States, 48532
Contact: Heather Rodgers    810-342-3829    heatherR@mclaren.com   
Principal Investigator: Trevor Signh, MD         
MSU Breslin Cancer Center Recruiting
Lansing, Michigan, United States, 48910
Contact: Karen Baker    517-975-9547    karen.baker@hc.msu.edu   
Principal Investigator: Borys Hrinczenko, MD         
Lapeer Regional Medical Center Not yet recruiting
Lapeer, Michigan, United States, 48446
Contact: Valentyna Onishchuk    810-245-5326    valentynao@mclaren.org   
Principal Investigator: Sai Ramish Bikkina, MD         
Mount Clemens Regional Medical Center Not yet recruiting
Mount Clemens, Michigan, United States, 48043
Contact: Valentyna Onishchuk    586-493-7509    valentynao@mclaren.org   
Principal Investigator: Susanna S Gaikazian, MD         
Providence Hospital and Medical Center Recruiting
Southfield, Michigan, United States, 48075
Contact: Deborah Beattie       Deborah.Beattie@stjohn.org   
Principal Investigator: Vinay Malviya, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: John Beranek    507-538-1424    beranek.john@mayo.edu   
Principal Investigator: Brigitte Barrette, MD         
United States, Missouri
Missouri Cancer Associates Recruiting
Columbia, Missouri, United States, 65201
Contact: Lisa Mision    573-817-8538    lisa.mision@usoncology.com   
Principal Investigator: Joseph Muscato, MD         
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Lynne Lippmann    314-362-1760    lippmannl@wudosis.wustl.edu   
Principal Investigator: David Mutch, MD         
United States, Montana
Bozeman Deaconess Hospital Cancer Center Recruiting
Bozeman, Montana, United States, 59715
Contact: Barbara Buening       bbuening@seattlecca.org   
Principal Investigator: Jack Hensold, MD         
United States, Nevada
Nevada Cancer Institute Recruiting
Las Vegas, Nevada, United States, 89135
Contact: Shamine Poyner    702-822-5142    spoynor@nvcancer.org   
Principal Investigator: Karen Jacks, MD         
United States, New Jersey
John Theurer Cancer Centre at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Phyllis Marchand    551-996-0747    pmarchand@HackensackUMC.org   
Principal Investigator: Donna M McNamara         
Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Donna Mura    973-971-5235    donna.mura@atlantichealth.org   
Principal Investigator: Brian Slomovitz, MD         
Holy Name Medical Center Recruiting
Teaneck, New Jersey, United States, 07666
Contact: Marissa Van Orden    201-541-6384    vanorden@holyname.org   
Principal Investigator: Beata Pieczara, MD         
United States, New Mexico
Southwest Gynecologic Oncology Associates Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Ruby Allen    505-263-6669    rallen@nmcca.org   
Principal Investigator: Karen Finkelstein, MD         
United States, New York
Schwartz Gynecologic Oncology, PLLC Recruiting
Brightwaters, New York, United States, 11718
Contact: Jenny Stanwix    631-894-1033    jes@islandoncology.com   
Principal Investigator: Benjamin Schwartz, MD         
United States, North Carolina
Blumenthal Cancer Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Sarah Norek    704-355-1520    sarah.norek@carolinashealthcare.org   
Principal Investigator: Robert Wendell Naumann, MD         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Beatrice Nelson    919-684-3792    beatrice.nelson@duke.edu   
Principal Investigator: Angeles Alvarez Secord, MD         
United States, Ohio
Greater Cincinnati OB/GYN, Inc Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Melanie Lawhorn    513-584-5044    melanie.lawhorn@uc.edu   
Principal Investigator: William Richards, MD         
Miami Valley Hospital Recruiting
Kettering, Ohio, United States, 45429
Contact: Wanda Caplinger    937-395-8020    wanda.caplinger@khnetwork.org   
Principal Investigator: Thomas Reid, MD         
Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Julie Moon    419-291-8027    julie.moon@promedica.org   
Principal Investigator: Garth Phibbs, MD         
United States, Oregon
Willamette Valley Cancer Institute and Research Center Recruiting
Springfield, Oregon, United States, 97477
Contact: Jeanne Schaffer    541-741-3451    jeanne.schaffer@usoncology.com   
Principal Investigator: Michael A Monticelli, MD         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Susan Nolte    215-481-5809    snolte@amh.org   
Principal Investigator: Parviz Hanjani, MD         
United States, South Carolina
Medical University of South Carolina, Dept. OB/GYN Recruiting
Charleston, South Carolina, United States, 29425
Contact: Shanta Salzer, MD    843-792-7463    salzers@musc.edu   
Principal Investigator: Whitney Graybill, MD         
Cancer Centers of the Carolinas Recruiting
Greenville, South Carolina, United States, 29605
Contact: Gina Norris    864-679-3966    gina.norris@usoncology.com   
Principal Investigator: William Edenfield, MD         
United States, Tennessee
Chattanooga GYN Oncology Recruiting
Chattanooga, Tennessee, United States, 37411
Contact: Jennifer Wiggs    423-698-2050    Jennifer@chatgynonc.com   
Principal Investigator: Donald Chamberlain, MD         
Chattanooga's Program in Women's Oncology Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Alice Donaldson    423-266-3636    research@cpiwo.com   
Principal Investigator: Stephen De Pasquale,, MD         
United States, Texas
Texas Oncology- Central Austin Cancer Center Recruiting
Austin, Texas, United States, 78731
Contact: Andrew Nilson    512-427-9467    andrew.nilson@usoncology.com   
Principal Investigator: Michael Teneriello, MD         
Texas Oncology, P.A. Recruiting
Bedford, Texas, United States, 76022
Contact: Cindi Schoenfeldt    817-359-9033    cindi.schoenfeldt@usoncology.com   
Principal Investigator: Mark Messing, MD         
Texas Oncology-Dallas, PA Presbyterian Withdrawn
Dallas, Texas, United States, 75231
Mary Crowley Medical City Clinic Recruiting
Dallas, Texas, United States, 75230
Contact: Shehnaz Moosa    214-658-1989    smoosa@marycrowley.org   
Principal Investigator: John Nemunaitis, MD         
Texas Oncology Not yet recruiting
Tyler, Texas, United States, 75702
Contact: Linda Dunklin    903-579-9800    linda.dunklin@usoncology.com   
Principal Investigator: Donald Richards, MD         
United States, Washington
Columbia Basin Hematology and Oncology Recruiting
Kennewick, Washington, United States, 99336
Contact: Heather Johansen    509-783-0144    hjohansen@cbho.org   
Principal Investigator: Thomas Rado, MD         
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Monica Dherin    206-667-4696    mdherin@fhcrc.org   
Principal Investigator: Barbara Goff, MD         
MultiCare Health System Recruiting
Tacoma, Washington, United States, 98415
Contact: Diane Miller    253-403-5265    diane.miller@multicare.org   
Principal Investigator: Troy Wadsworth, MD         
Belgium
Cliniques Universitaires Saint-Luc Service d'oncologie Not yet recruiting
Bruxelles, Belgium, 1200
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Jean-François Baurain         
UZ Antwerpen -Oncologie Clinical Trials Not yet recruiting
Edegem, Belgium, 2650
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Manon Huizing         
UZ Gent- Clincal Studies Medical Oncology Not yet recruiting
Gent, Belgium, 9000
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Hannelore Denys         
Studiebureau Gynaecologische Oncologie Not yet recruiting
Leuven, Belgium, B - 3000
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Ignace Vergote         
Hopital du Jour, E4 Clinique Sainte-Elisabeth Not yet recruiting
Namur, Belgium, 5000
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Cécile Ninane Vuylsteke         
Clinical Trials Oncology & Wetenschappelijk l Not yet recruiting
Wilrijk, Belgium, B - 2610
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Luc Dirix         
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Leela Pillay    403-521-3016    leela.pillay@albertahealthservices.ca   
Principal Investigator: Prafull Ghatage, MD         
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Judy Yamamoto    780-577-8105    judy.yamamoto@albertahealthservices.ca   
Principal Investigator: Katia Tonkin         
Canada, Nova Scotia
Nova Scotia Cancer Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Kara Bursey    902-473-5679    kara.bursey@cdha.nshealth.ca   
Principal Investigator: Robert Grimshaw, MD         
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Shelina Salbur    416-946-4501 ext 3690    shelina.sabur@uhn.on.ca   
Principal Investigator: Amit Oza         
Canada, Quebec
MUHC-Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Natacha Albarracin    514-934-1934 #31975    natacha.albarracin@muhc.mcgill.ca   
Principal Investigator: Lucy Gilbert, MD         
CHUM-Hopital Notre Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Nathalie Grenier    514-890-8000 x25165    nathalie.grenier.chum@ssss.gouv.qc.ca   
Principal Investigator: Diane Provencher, MD         
CHUS-Hopital Fleurimont Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Annie Bourbonnais    819-346-1110 ext 12880    abourbonnais.chus@ssss.gouv.qc.ca   
Principal Investigator: Paul Bessette, MD         
Czech Republic
Masarykuv onkologicky ustav Not yet recruiting
Brno, Czech Republic, 65653
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Josef Chovanec         
Clinic of gynaecology and Obstetrics, Fakultni nemocnice Hradec Kralove Not yet recruiting
Hradec Kralove, Czech Republic, 50005
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Jiri Spacek         
Clinic of Gynaecology and Obstetrics Not yet recruiting
Praha, Czech Republic, 12000
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: David Cibula         
France
Unite de Recherche Clinique Institut BERGONIE Centre Regional de lutte contre le Cancer Not yet recruiting
BORDEAUX Cedex, France, 33076
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Anne Floquet         
Departement de Recherche Clinique Centre Francois Baclesse Not yet recruiting
Caen, France, 14000
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Florence Joly         
Clinique Victor HUGO - Centre Jean Bernard Not yet recruiting
Le Mans, France, 72000
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Hugues Bourgeois         
Unite Integree de Recherche Clinique Centre Oscar Lambret Not yet recruiting
Lille, France, 59000
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Anne Lesoin         
Bureau d'Etudes Cliniques Centre Leon Berard Not yet recruiting
Lyon Cedex, France, 69373
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Isabelle Ray-Coquard         
Unite de Recherche Clinique Centre Val d'Aurelle Not yet recruiting
Montpellier Cedex, France, 34298
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Michel Fabbro         
Departement des Essais Cliniques Centre Catherine de Sienne Not yet recruiting
Nantes Cedex, France, 44202
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Alain Lortholary         
Bureau des Essais Cliniques Centre Antoine LACASSAGNE - CRLC Not yet recruiting
NICE Cedex, France, 06189
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Philippe Follana         
Service d'Oncologie Medicale Hopital TENON Not yet recruiting
Paris, France, 75020
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Fredric Selle         
Attachee de Recherche Clinique Service d'Oncologie Medicale - Pavillon 1F Not yet recruiting
Pierre Benite Cedex, France, 69495
Contact: Ellen Spellman, PhD    +44 (0) 790753    ellen.spellman@ppdi.com   
Principal Investigator: Cecile Fournel-Federico         
Bureau de Recherche Clinique Institut Jean Godinot Not yet recruiting
Reims Cedex, France, 51056
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Aude-Marie Savoye         
Bureau des Essais Cliniques Clinique Armoricaine de radiologie Not yet recruiting
Saint Brieuc Cedex, France, 22015
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Anne-Claire Hardy-Bessard         
Centre d'Evaluation Clinique Centre rene Gauducheau - Institut de Cancerologie de l'Ouest. Not yet recruiting
Saint Herblain Cedex, France, 44805
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Dominique Berton-Rigaud         
Service d'oncologie Hematologie Hopital Civil de Strasbourg Not yet recruiting
Strasbourg, France, 67091
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Jean-Emmanuel Kurtz         
Service d'oncologie Medicale Aile B2 / 5eme etage Hotel DIEU Not yet recruiting
Strasbourg, France, 67091
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Jerome Alexandre         
Institut Claudius Reguad Bureau Essais Cliniques Not yet recruiting
Toulouse, France, 31052
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Florence Gladieff         
Unite de Recherche Clinique Centre Alexis Vautrin Not yet recruiting
Vandoeuvre Les Nancy, France, 54511
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Béatrice Weber         
Institut Gustave-Roussy Not yet recruiting
Villejuif Cedex, France, 94805
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Youssef Tazi         
Germany
Klinikum Chemnitz gGmbH Not yet recruiting
Chemnitz, Germany, 09116
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Petra Krabisch         
Universitätsklinikum Carl Gustav Carus an der TU Dresden Not yet recruiting
Dresden, Germany, 01307
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Pauline Wimberger         
Universitätsklinikum Essen Not yet recruiting
Essen, Germany, 45147
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Martin L. Heubner         
Klinikum der Friedrich-Schiller-Universität Jena Not yet recruiting
Jena, Germany, 07743
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Ingo Runnebaum         
Klinikum St. Georg gGmbH Not yet recruiting
Leipzig, Germany, 04129
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Uwe Kohler         
Asklepios Klinik Lich GmbH Not yet recruiting
Lich, Germany, 35423
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Alexandra Bender         
Klinikum rechts der Isar der Technische Universität München Not yet recruiting
Munchen, Germany, 81675
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Marion Kiechle         
Rotkreuzklinikum München Not yet recruiting
Munchen, Germany, 80637
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Claus A. Hanusch         
Rotkreuzklinikum Munchen Not yet recruiting
Munchen, Germany, 80637
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Claus A. Hanusch         
Elblandklinikum Riesa Not yet recruiting
Riesa, Germany, 01589
Contact: Ellen Spellman, PhD    +44(0)1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Dirk G. Kieback         
Hungary
Békés Megyei Képviselőtestület Pándy Kálmán Kórháza Recruiting
Gyula, Hungary, 5700
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Bela Piko         
Kaposi Mor Oktato Korhaz Recruiting
Kaposvar, Hungary, 7400
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Zoltan Volgyi         
Israel
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Amnon Amit         
Rambam Medical Center Not yet recruiting
Haifa, Israel, 31096
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Amnon Amit         
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel, 91031
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Ora S Rosengarten         
Hadassah University Hospital Ein Kerem Not yet recruiting
Jerusalem, Israel, 91120
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel, 91031
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Ora S. Rosengarten         
Hadassah University Hospital Ein Kerem Recruiting
Jerusalem, Israel, 91120
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: David Z. Edelmann         
Meir Medical Center Not yet recruiting
Kfar Saba, Israel, 44281
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Ami Fishman         
Rabin Medical Center Not yet recruiting
Petach Tikva, Israel, 49100
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Ram Eitan         
The Chaim Sheba Medical Center Recruiting
Ramat-Gan, Israel, 34362
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Ronie Shapira-Frommer         
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Safra         
The Lady Davis Carmel Medical Hospital Not yet recruiting
Tel-Hashomer, Israel, 52621
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Mariana Steiner         
Korea, Republic of
National Cancer Center Not yet recruiting
Ilsan-gu Gyeonggi-do, Korea, Republic of, 410-769
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Sang Yoon Park         
Asan Medical Center Division of Oncology Not yet recruiting
Seoul, Korea, Republic of, 138736
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Kyung Hae Jung         
Seoul St.Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of, 137701
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Sook-Hee Hong         
Severance Hospital, Yonsei University Healthcare System Not yet recruiting
Seoul, Korea, Republic of, 120752
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Soohyeon Lee         
Poland
Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Ginekologicznej Not yet recruiting
Gdansk, Poland, 80-402
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Dariusz Wydra         
Regionalny Osrodek Onkologiczny Oddzial Radioterapii Ginekologicznejz Not yet recruiting
Lodz, Poland, 93-509
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Janusz Sobotkowski         
Oddzial Onkologii Ginekologicznej Not yet recruiting
Opole, Poland, 45-060
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Kamila Czerw         
Klinika Onkologii Ul. Szaserów Not yet recruiting
Polska, Poland, 04-141
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Cezary Szczylik         
Oddzial Ginekologii Onkologicznej Klinika Onkologii Not yet recruiting
Poznan, Poland, 60-569
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Janina Markowska         
Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Doroslych i Dziewczat Not yet recruiting
Szczecin, Poland, 70-111
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Janusz Menkiszak         
Russian Federation
State Institution of Healthcare "Kursk Regional Oncology Centre" of Kursk region healthcare committee" Recruiting
Kursk, Russian Federation, 305035
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Igor Kiselev         
Moscow City State Institution of Healthcare Moscow City Oncology Hospital #62 of Moscow City Board of Health Recruiting
Moscovskaya Oblast, Russian Federation, 143423
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Anatoly Mahkson         
Russian Academy of Medical Sciences Institution Russian Oncology Research Center Recruiting
Moscow, Russian Federation, 115478
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Lichinitser         
Scientific and Clinical Centre for Oncology and Neurology "Biotherapy", LLC Not yet recruiting
Novosibirsk, Russian Federation, 630090
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Lantsukhay         
FGBU Medical Radiology Research Center of Ministry Healthcare and Social Development of RF Recruiting
Obninsk, Russian Federation, 249036
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Krikunova         
St. Petersburg State Institution of Healthcare City Clinical Oncology Center Active, not recruiting
St-Petersburg, Russian Federation, 198255
Federal State Institution Research Oncology Institute Not yet recruiting
St. Petersburg, Russian Federation, 197758
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Krivorotko         
Yaroslavl Region State Institution of Healthcare "Regional Clinical Oncology Hospital Recruiting
Yaroslavl, Russian Federation, 150040
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Sergey Cheporov         
Spain
Hospital Clinic Provencial de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Vidal Boixader         
Vall d' Hebron Research Institute (VHIR) Recruiting
Barcelona, Spain, 08035
Contact: Ellen Spellman, PhD    +44 (0) 790573    ellen.spellman@ppdi.com   
Principal Investigator: Del Campo         
Hospital General Universitario de Elche. Servicio de Oncologia Medica Recruiting
Elche, Spain, 03203
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.Spellman@ppdi.com   
Principal Investigator: Sanchez         
Hospital Universitari de Girona Dr. Josep Trueta Recruiting
Girona, Spain, 17007
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Beltran         
Hospital General Universitario Gregorio Maranon Recruiting
Madrid, Spain, 28007
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Arranz         
Hospital 12 de Octubre Recruiting
Madrid, Spain, 28033
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Mendiola         
Hospital Universitario Puerta de Hierro de Majadahonda Recruiting
Madrid, Spain, 28222
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Maximiano         
Hospital Madrid Sanchinarro Recruiting
Madrid, Spain, 28050
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Padilla         
Clinica Universidad de Navarra Recruiting
Navarra, Spain, 31008
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Espinós Jiménez         
Hospital Clínico de Valencia Recruiting
Valencia, Spain, 46010
Contact: Ellen Spellman    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Cervantes Ruiperez         
United Kingdom
Beatson West of Scotland Cancer Centre Not yet recruiting
Glasgow, United Kingdom, G12 0YN
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Reed         
UCL Hospitals NHS Foundation Trust Not yet recruiting
London, United Kingdom, NW1 2BU
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Jonathan Ledermann         
Royal Marsden Hospital Not yet recruiting
London, United Kingdom, SW3 6JJ
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Banerjee         
Mount Vernon Cancer Centre, Not yet recruiting
Middlesex, United Kingdom, HA6 2RN
Contact: Ellen Spellman, PhD    +44 (0) 1223 790573    ellen.spellman@ppdi.com   
Principal Investigator: Hall         
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Binh Nguyen, MD Endocyte
  More Information

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01170650     History of Changes
Other Study ID Numbers: 8109-002, EC-FV-06
Study First Received: July 7, 2010
Last Updated: April 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
cancer
ovarian
platinum-resistant
Phase III
EC145
EC20

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014