AzTrials
AzTrials

Ovarian NeoplasmsPhase 3NCT00057720

TLK286 (Telcyta) vs. Doxil/Caelyx or Hycamtin in Platinum Refractory or Resistant Ovarian Cancer

A Phase 3 study testing TLK286 HCl for injection, topotecan hydrochloride for injection and doxorubicin HCl liposome injection in people with Ovarian Neoplasms, run by Telik at 320 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to demonstrate superiority in survival in favor of TLK286 as compared to active control therapy with Doxil/Caelyx or Hycamtin in the intent-to-treat (ITT) populations. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Neoplasms
What is being tested?
TLK286 HCl for injection, topotecan hydrochloride for injection and doxorubicin HCl liposome injection
Type of treatment
Injection or infusion
How many people
440 participants
Where
320 sitesin 13 countries
Study dates
Jun 2003to Dec 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Considered platinum refractory or resistant according to standard criteria
  • Progressed during or following completion of one second-line treatment with Doxil/Caelyx or Hycamtin
  • Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube, or primary peritoneal cancer
  • Measurable disease according to RECIST criteria with documented tumor progression

Who cannot join

  • Treatment with second-line chemotherapy other than Doxil/Caelyx or Hycamtin
  • History of whole pelvis radiation therapy within 12 months of enrollment
  • Clinically significant cardiac disease
  • Evidence of gross hematuria at the time of study entry
  • Any signs of intestinal obstruction interfering with nutrition at the time of study entry
  • Pregnant or lactating women

Trial locations and contacts

320 sites in 13 countries.

320 sites in 13 countries

United States234 sites

  • Western Washington Oncology

    Aberdeen, Washington, 98520

  • Abington Mem. Hospita/Rosenfield Cancer Center

    Abington, Pennsylvania, 19001

  • UNM Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131

  • Amarillo Cancer Center

    Amarillo, Texas, 79106

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Arlington Cancer Center

    Arlington, Texas, 76012

  • Benjamin Schwartz, M.D.

    Babylon, New York, 11702

  • Southern California Permanente Medical Group

    Baldwin Park, California, 91706

  • Sinai Cancer Institute

    Baltimore, Maryland, 21205

  • North Shore Oncology Hematology Associates

    Barrington, Illinois, 60010

  • MacNeal Cancer Center

    Berwyn, Illinois, 60402

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Deaconess Billings Clinic

    Billings, Montana, 59101

  • Hematology & Oncology Centers Northern Rockies

    Billings, Montana, 59101

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58501

  • Odyssey Research Services

    Bismarck, North Dakota, 58501

  • The Center for Hematology-Oncology

    Boca Raton, Florida, 33486

  • St. Elizabeth's Med. Ctr.

    Boston, Massachusetts, 02135

  • Providence Saint Joseph Medical Center

    Burbank, California, 91505-4866

  • Hematology Oncology Centers of the Northern Rockies

    Butte, Montana, 59701

  • Western Washington Oncology

    Centralia, Washington, 98531

  • Carolina Center of Gynecologic Oncology, PA

    Charleston, South Carolina, 29407

  • Blumenthal Cancer Center

    Charlotte, North Carolina, 28203

  • Presbyterian Gynecologic Oncology

    Charlotte, North Carolina, 28204

  • Presbyterian Hospital Center for Cancer Research

    Charlotte, North Carolina, 28204

  • Chattanooga Oncology & Hematology Associates, P.C.

    Chattanooga, Tennessee, 37404

  • Memorial Hospital

    Chattanooga, Tennessee, 37404

  • Swedish Covenant Cancer Center

    Chicago, Illinois, 60625

  • Hematology Oncology Associates of Illinois (HOAI)

    Chicago, Illinois, 60657

  • Chippewa Falls Cancer Center

    Chippewa Falls, Wisconsin, 54729

  • Marilyn Norton, M. D.

    Chula Vista, California, 91911

  • Rosalba Rodriguez, M. D.

    Chula Vista, California, 91911

  • Oncology/Hematology Care, Inc.

    Cincinnati, Ohio, 45013

  • Barrett Cancer Center

    Cincinnati, Ohio, 45219-0501

  • Barrett Cancer Center

    Cincinnati, Ohio, 45219

  • Oncology/Hematology Care, Inc.

    Cincinnati, Ohio, 45219

  • UC Physician's Medical Arts Bldg.

    Cincinnati, Ohio, 45219

  • UC Physician's Medical Arts Building

    Cincinnati, Ohio, 45219

  • University Hospital

    Cincinnati, Ohio, 45219

  • Oncology/Hematology Care, Inc.

    Cincinnati, Ohio, 45230

  • Oncology/Hematology Care, Inc.

    Cincinnati, Ohio, 45236

  • Oncology/Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • Metro Health Medical Center

    Cleveland, Ohio, 44109

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Hematology Oncology Centers of the Northern Rockies

    Cody, Wyoming, 82414

  • Ellis Fischel Cancer Center

    Columbia, Missouri, 65203

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina, 29201

  • Mid-Ohio Oncology Hematology St. Anne's

    Columbus, Ohio, 43081

  • Mid Ohio Oncology Hematology

    Columbus, Ohio, 43213

  • Mid-Ohio Oncology Hematology

    Columbus, Ohio, 43213

  • Gynecologic Oncology

    Columbus, Ohio, 43222

  • Mount Carmel Health

    Columbus, Ohio, 43222

  • Bay Area Research Cancer Group

    Concord, California, 94520

  • The Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Hematology and Oncology Specialists, LLC

    Covington, Louisiana, 70433

  • Covington Multicare - Oncology Clinic

    Covington, Washington, 98042

  • Oncology/Hematology Care, Inc.

    Crestview, Kentucky, 41017

  • Dallas Oncology Consultants

    Dallas, Texas, 75201

  • Texas Cancer Associates

    Dallas, Texas, 75231

  • Danville Hematology and Oncology, Inc.

    Danville, Virginia, 24541

  • Wright State Univ. School of Medicine

    Dayton, Ohio, 45409

  • Cancer Care Specialists of Central IL

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • The Center for Hematology-Oncology

    Delray Beach, Florida, 33484

  • Suburban Hematology Oncology

    Duluth, Georgia, 30096

  • St. Mary's Duluth Clinic

    Duluth, Minnesota, 55805

  • Advanced Imaging

    Dunmore, Pennsylvania, 18512

  • Hematology & Oncology Associates of NEPA

    Dunmore, Pennsylvania, 18512

  • Regional Cancer Center

    Eau Claire, Wisconsin, 54701

  • Cancer Care Specialists of Central IL-Crossroads Cancer Care Center

    Effingham, Illinois, 62401

  • Elkhart General Hospital

    Elkhart, Indiana, 46514

  • Michiana Hematology Oncology

    Elkhart, Indiana, 46514

  • Southwest Cancer Care

    Escondido, California, 92025

  • Dakota Cancer Institute

    Fargo, North Dakota, 58103

  • Odyssey Research Services

    Fargo, North Dakota, 58104

  • Joliet Oncology-Hematology Associates, Ltd.

    Flossmoor, Illinois, 60422

  • Texas Oncology, PA

    Fort Worth, Texas, 76104

  • Southwest Fort Worth Cancer Center

    Fort Worth, Texas, 76132

  • The Consultant Group

    Franklin, Tennessee, 37067

  • California Oncology of the Central Valley

    Fresno, California, 93710

  • The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066

  • Gynecologic Oncology Research and Development

    Greenville, South Carolina, 29605

  • Kaiser Permanente Oncology Clinical Trials Program

    Hayward, California, 94545

  • The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC

    Hermitage, Tennessee, 37076

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Sheridan Clinical Research, Inc.

    Hollywood, Florida, 33021

  • Kaiser Permanente - Moanalua Medical Center

    Honolulu, Hawaii, 96819

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96826

  • Univ. of Hawaii, Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Univ. of TX, MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana Cancer Pavilion

    Indianapolis, Indiana, 46202

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202

  • St. Vincent Gynecologic Oncology

    Indianapolis, Indiana, 46260

  • St. Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • St. Vincent Hospital and Helath Care Center

    Indianapolis, Indiana, 46260

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of Florida Health Science Center/Jacksonville

    Jacksonville, Florida, 32209

  • Joliet Oncology-Hematology Associates, Ltd.

    Joliet, Illinois, 60435

  • Saint Mary's Health System, Inc.

    Knoxville, Tennessee, 37917

  • Hall and Martin, M.D.'s, P.C.

    Knoxville, Tennessee, 37920

  • Fort Sanders Parkwest Medical Center

    Knoxville, Tennessee, 37923

  • Gynecologic Oncology Associates

    La Jolla, California, 92037

  • Grossmont Hospital

    La Mesa, California, 91942

  • Sharp Rees-Stealy

    La Mesa, California, 91942

  • North Shore Oncology Hematology Associates - Deerpath Medical Associates

    Lake Forest, Illinois, 60045

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48909

  • Nevada Cancer Center

    Las Vegas, Nevada, 89109

  • Suburban Hematology-Oncology Associates

    Lawrenceville, Georgia, 30045

  • The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC

    Lebanon, Tennessee, 37087

  • North Shore Oncology Hematology Associates

    Libertyville, Illinois, 60048

  • Little Rock Hematology Oncology Associates

    Little Rock, Arkansas, 72205

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • LLU Faculty Medical Offices

    Loma Linda, California, 92354

  • LLU Faculty Meidical Offices

    Loma Linda, California, 92354

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095

  • Women's Cancer Center - Community Hospital Los Gatos

    Los Gatos, California, 95032

  • Univ. of Louisville, Div. of Gynecologic Oncology

    Louisville, Kentucky, 40202

  • Med-Onc/Hem

    Malone, New York, 12953

  • Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • Saint Joseph's Hospital

    Marshfield, Wisconsin, 54449

  • Wisconsin Rapid Cancer Center

    Marshfield, Wisconsin, 54494

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • North Shore Oncology Hematology Associates

    McHenry, Illinois, 60050

  • Merrill Cancer Center

    Merrill, Wisconsin, 54452

  • OncRx (Pharmacy)

    Metairie, Louisiana, 70002

  • Medical Consultants, Ltd.

    Milwaukee, Wisconsin, 53215

  • Marshfield Clinc - Lakeland Center

    Minocqua, Wisconsin, 54548

  • Marshfield Clinic - Lakeland Center

    Minocqua, Wisconsin, 54548

  • Joliet Oncology-Hematology Associates, Ltd.

    Morris, Illinois, 60450

  • The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC

    Murfreesboro, Tennessee, 37130

  • Southwest Cancer Care

    Murrieta, California, 92562

  • The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • The Consultant Group

    Nashville, Tennessee, 37205

  • The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC

    Nashville, Tennessee, 37205

  • The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC

    Nashville, Tennessee, 37207

  • The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC

    Nashville, Tennessee, 37211

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07754

  • The Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08903

  • Hematology-Oncology Associates of Rockland

    New City, New York, 10956

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • North Shore-Long Island Jewish Health System/Medical Center

    New Hyde Park, New York, 11040

  • Hematology and Oncology Specialists, LLC

    New Orleans, Louisiana, 70115

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Bellevue Hospital Center

    New York, New York, 10016

  • Comprehensive Cancer Center Medical Practice Offices

    New York, New York, 10016

  • New York University Medical Center - Tisch Hospital

    New York, New York, 10016

  • NYU School of Medicine

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 11021

  • Gyncologic Oncology Associates

    Newport Beach, California, 92663

  • Whittingham Cancer Center at Norwalk Hospital

    Norwalk, Connecticut, 06856

  • The Union State Bank Cancer Center at Nyack Hospital

    Nyack, New York, 10960

  • Kaiser Permanente Oncology Clinical Trials Program

    Oakland, California, 94611

  • N. County Oncology Medical

    Oceanside, California, 92056

  • OU Medical Center - Everett Tower

    Oklahoma City, Oklahoma, 73104

  • OU Physicians' Bldg.

    Oklahoma City, Oklahoma, 73104

  • Presbyterian

    Oklahoma City, Oklahoma, 73104

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Western Washington Oncology

    Olympia, Washington, 98502

  • Western Washington Oncology

    Olympia, Washington, 98506

  • Florida Hospital

    Orlando, Florida, 32803

  • Gynecologic Oncology

    Orlando, Florida, 32804

  • Florida Hospital Memorial Division, Cancer Care Center

    Ormond Beach, Florida, 32174

  • Florida Hospital Memorial Division

    Ormond Beach, Florida, 32174

  • Palm Beach Cancer Institute

    Palm Beach Gardens, Florida, 33410

  • Gynecologic Oncology Associates

    Pembroke Pines, Florida, 33028

  • Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Hematology/Oncology Associates of Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Kaiser Permanente Nw, Oncology Research

    Portland, Oregon, 97227

  • Oregon Health & Science University

    Portland, Oregon, 97239-3098

  • Oregon Health Science University

    Portland, Oregon, 97239

  • Southwest Cancer Care

    Poway, California, 92064

  • Kaiser Permanente Oncology Clinical Trials Program

    Redwood City, California, 94063

  • Diagnostic Radiology Associates

    Rice Lake, Wisconsin, 54868

  • Lakeview Medical Center

    Rice Lake, Wisconsin, 54868

  • Marshfield Clinic - Indianhead Center

    Rice Lake, Wisconsin, 54868

  • Gynecologic-Oncology

    Rochester, New York, 14620

  • Kaiser Permanente Oncology Clinical Trials Program

    Roseville, California, 95661

  • Kaiser Permanente Oncology Clinical Trials Program

    Sacramento, California, 95825

  • Southern California Permanente Medical Group

    San Diego, California, 92120

  • Medical Oncology Associates-SD

    San Diego, California, 92123

  • Sharp Healthcare Clinical Oncology Research

    San Diego, California, 92123

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Sharp Rees-Stealy

    San Diego, California, 92123

  • Kaiser Permanente Oncology Clinical Trials Program

    San Francisco, California, 94115

  • Kaiser Permanente Oncology Clinical Trials Program

    San Rafael, California, 94903

  • Kaiser Permanente Oncology Clinical Trials Program

    Santa Clara, California, 95051

  • Kaiser Permanente Oncology Clinical Trials Program

    Santa Rosa, California, 95403

  • Kaiser Permanente Oncology Clinical Trails Program

    Santa Teresa, California, 95119

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Horizon's West Medical Group

    Scottsbluff, Nebraska, 69361

  • Viewmont Medical Services

    Scranton, Pennsylvania, 18508

  • Community Medical Center

    Scranton, Pennsylvania, 18510

  • Mercy Health Partners

    Scranton, Pennsylvania, 18510

  • Moses Taylor Hospital

    Scranton, Pennsylvania, 18510

  • Western Washington Oncology

    Shelton, Washington, 98584

  • Hematology Oncology of the Northern Rockies

    Sheridan, Wyoming, 82801

  • LSU Health Sciences Center

    Shreveport, Louisiana, 71103

  • Sioux Valley Clinic Clinical Research Center

    Sioux Falls, South Dakota, 57104

  • Sioux Valley Clinic Oncology

    Sioux Falls, South Dakota, 57104

  • Sioux Valley Hospital - North Center Radiology

    Sioux Falls, South Dakota, 57104

  • Sioux Calley Clinic OBGYN Ltd.

    Sioux Falls, South Dakota, 57105

  • Hematology Oncology Associates of Illinois (HOAI)

    Skokie, Illinois, 60076

  • Midwest Cancer Research Group, Inc.

    Skokie, Illinois, 60077

  • The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC

    Smyma, Tennessee, 37167

  • Suburban Hematology Oncology

    Snellville, Georgia, 30078

  • Michiana Hematology Oncology

    South Bend, Indiana, 46617

  • St. Joseph's Regional

    South Bend, Indiana, 46617

  • Saint Joseph's Regional

    South Bend, Indiana, 46634

  • Women's Cancer Research Foundation, Inc.

    South Miami, Florida, 33143

  • Kaiser Permanente Oncology Clinical Trials Program

    South San Francisco, California, 94080

  • Gynecologic Oncology Research and Development

    Spartanburg, South Carolina, 29303

  • St. Louis University, Dept. of Ob-Gyn and Women's Health

    St Louis, Missouri, 63117

  • Gynecology & Oncology Consultants, PC

    St Louis, Missouri, 63141

  • Saint John's Mercy Hospital

    St Louis, Missouri, 63141

  • Hematology Oncology, P.C.

    Stamford, Connecticut, 06902

  • Saint Michael Hospital

    Stevens Point, Wisconsin, 54481

  • Allenmore Hospital - Hematology Oncology Clinic

    Tacoma, Washington, 98405

  • MultiCare Health System - Medical Oncology

    Tacoma, Washington, 98405

  • Associates in Hematology-Oncology, P.C.

    Upland, Pennsylvania, 19013

  • Kaiser Permanente Oncology Clinical Trials Program

    Vallejo, California, 94589

  • Kaiser Permanente Oncology Clinial Trials Program

    Walnut Creek, California, 94596

  • Wausau Cancer Center

    Wausau, Wisconsin, 54401

  • Palm Beach Cancer Institute

    Wellington, Florida, 33414

  • Good Samaritan Hospital Medical Center

    West Islip, New York, 11795

  • South Bay OB/GYN

    West Islip, New York, 11795

  • Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

  • Research Support Personnel, LLC

    Wichita, Kansas, 67208

  • Associates in Women's Health

    Wichita, Kansas, 67214

  • Piedmont Hematology Oncology Assoc., PA-Salem Research Group

    Winston-Salem, North Carolina, 27103

  • Salem Research Group, Inc.

    Winston-Salem, North Carolina, 27103

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

Argentina13 sites

  • Hospital Italiano Regional del Sur

    Bahía Blanca, Buenos Aires, B8001HXM

  • Hospital Italiano de Buenos Aires

    Buenos Aires, Buenos Aires, C1181ACH

  • Sanatorio Municipal Dr. Julio Mendez

    Buenos Aires, Buenos Aires, C1405CNF

  • Hospital General de Agudos "Carlos G. Durand"

    Buenos Aires, Buenos Aires, C1405DCS

  • Complejo Medico de la Policia Federal Argentina "Churruca-Visca"

    Buenos Aires, Buenos Aires, C1437JCP

  • Hospital de Oncologia Maria Curie

    Buenos Aires, Buenos Aires

  • Policlinica Privada Instituto de Medicina Nuclear

    Buenos Aires, Buenos Aires

  • Hospital Donacion Francisco Santojanni

    Buenos Aires, 1408

  • Complejo Medico de la Policia Federal Argentina "Churruca-Visca"

    Buenos Aires, 1437

  • Hospital General de Agudos Donacion F. Santojanni

    Capital Federal, Buenos Aires, 1408

  • Sociedad de Beneficencia Hospital Italiano

    Córdoba

  • Hospital Universitario Austral

    Pilar, Buenos Aires, B1629AHJ

  • ISIS Clinica Especializada

    Santa Fe, Santa Fe Province, 03000

Other trials in Argentina

Brazil12 sites

  • Hospital de Clinicas de Porto Alegre

    Bairro Bom Fim, Porto Alegre, 90035-003

  • Hospital Vera Cruz

    Belo Horizonte, Minas Gerais, 30190-130

  • Hospital Luxemburgo

    Belo Horizonte, Minas Gerais, 32380

  • Hospital de Clinicas da Universidade Federal do Parana

    Curitiba, Paraná

  • Instituto do Cancer do Ceara

    Fortaleza, Ceará, 60430-230

  • Centro de Tratamento Oncologico de Londrina

    Londrina, Paraná, 86010-640

  • INCA Hospital de Oncologia Clinica

    Rio de Janeiro, Rio de Janeiro, 20220-410

  • Instituto Arnaldo Vieira de Carvalho

    São Paulo, São Paulo, 01223

  • Hospital do Cancer - A.C. Camargo

    São Paulo, São Paulo, 01509

  • Unifesp/Epm

    São Paulo, São Paulo, 04024-002

  • Hospital das Clinicas de Sao Paulo-FMUSP

    São Paulo, São Paulo, 05403

  • Instituto de Saude e Bem Estar da Mulher

    São Paulo, São Paulo

Other trials in Brazil

United Kingdom12 sites

  • St. Chad's Outpatients Unit, City Hospital

    Birmingham, B18 7QH

  • United Bristol Healthcare Trust - Bristol Oncology Centre

    Bristol, BS2 8ED

  • Beatson Oncology Centre

    Glasgow, G11 6NT

  • Beatson Oncology Unit

    Glasgow, G11 6NT

  • Medical Oncology - Guy's and St. Thomas' Hospital

    London, SE1 9RT

  • Department of Medicine-Royal Marsden Hospital

    London, SW3 6JJ

  • Department of Medical Oncology, Christie Hospital

    Manchester, M20 4BX

  • Medical Oncology (NCCT) - Newcastle General Hospital

    Newcastle upon Tyne, NE4 6BE

  • Dorset Cancer Centre - Poole Hospital

    Poole, BH15 2JB

  • Department of Cancer Medicine - Ninewells Hospital & Medical School

    Scotland, Dundee, DD1 9SY

  • Dept. of Med. Oncology/The Royal Marsden Hospital

    Sutton, Surrey, SMT 5PT

  • Velindre NHS Trust - Velindre Hospital

    Wales, CFT142TL

Other trials in United Kingdom

Czechia8 sites

  • Masarykuv Onkologicky Ustav

    Brno, 656 53

  • Fakultni Nemocnice - Onkologicka Klinika

    Doudlevecka 69, Plzen, 301 31

  • Batova krajska nemocnice Zlin, prispevkova organizace, Radiodiagnosticke oddeleni

    Havlickovo Nabrezi, Zlín, 76001

  • Batova krajska nemocnice Zlin, prispevkova organizace, Onkologicke oddeleni

    Havlickovo Nabrezi 600, Zlín, 76001

  • Krajska nemocnice Pardubice, Oddeleni radiacni onklogie

    Kyjevska 44, Pardubice, 53203

  • Fakultni nemocnice Olomouc, Onkologicka klinika

    Pardubice, Olomouc, 77520

  • Fakultni nemocnice, Onkologicka klinika

    Pilsen

  • Vseobecna Fakultni Nemocnice - Onkologicka Klinika

    Unemocnice, Prague, 12808

Other trials in Czechia

Germany8 sites

  • Universitatsklinikum Charite - Campus Virchow-Klinikum

    Berlin, D13353

  • St. Vincentius Kliniken

    Karlsruhe, D-76137

  • St. Vincentius Kliniken - Frauenkinik

    Karlsruhe, D76137

  • St. Vincentius Kliniken - Radiology

    Karlsruhe, D76137

  • Klinikum GroBhadern-Institut fur Radiologie

    Munich, D-81377

  • Klinikum GroBhadern-Zentrum fur Frauenheilkunde

    Munich, D81377

  • Universitaets-Frauenklinik Ulm

    Ulm, D89075

  • Dr. Horst-Schmidt-Kliniken GmbH

    Wiesbaden, D65199

Other trials in Germany

Spain8 sites

  • Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia Medica

    Barcelona, 08036

  • Hospital Clinic i Provincial

    Barcelona, 8035

  • Hospital General de Guadalajara

    Guadalajara

  • Servicio de Oncologia

    Madrid, 28007

  • Instituto Valenciano de Oncologia (IVO)

    Profesor Beltran Baguena, Valencia, 46009

  • Instituto Valenciano de Oncologia (IVO) Servicio de Oncologia

    Valencia, 46009

  • Instituto Valenciano de Oncologia (IVO) Servicio de Radiologia

    Valencia, 46009

  • Servicio Oncologia Hospital General Vall d'HebronPaseo

    Vall d'Hebron, Barcelona, 119-129

Other trials in Spain

Belgium7 sites

  • AZ-VUB Dienst Oncologie

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc

    Brussels, B 1200

  • Universitair Ziekenhuis Gent.

    Ghent, 9000

  • University Hospital Gasthuisberg

    Herestraat, Leuven, 49

  • Centre Hospitalier Regional de la Citadelle

    Liège, 4000

  • Algemeen Ziekenhuis Antwerpen

    Lindedreef, Antwerpen, 2020

  • Universitaire Ziekenhuis Antwerpen

    Wilrijkstraat, Edegem, 2650

Other trials in Belgium

Hungary7 sites

  • Semmelweis University, 1st Dept. of Obstetrics and Gynaecology

    Baross, H-1088

  • Uzsoki Street Hospital Dept. of Radiooncology

    Budapest, H-1145

  • Faculty of Gynaecologycal Oncology/Univ. of Debrecen

    Debrecen, 4032

  • Baranya County Hospital

    Pécs, 7632

  • Baranya County Hospital - Department of Oncology

    Rakoczi

  • Baranya County Hospital - Department of Radiology

    Rakoczi

  • SZTE, Department of Oncotherapy

    Szeged, 6720

Other trials in Hungary

South Africa6 sites

  • Wilgers Oncology Centre

    Die Wilgers X14, Pretoria, 41

  • Hopelands Cancer Centre

    Overport, Durban, 4091

  • Panorama Medical Centre

    Panorama, Cape Town, 7500

  • Eastern Cape Oncology Research Centre

    Port Elizabeth, 6001

  • Medical and Dental Centre

    Rosebank, Johannesburg, 2196

  • Rosebank Oncology Centre

    Saxonwold, Johannesburg, 2196

Other trials in South Africa

Chile2 sites

  • Servicio de Oncologia-Hospital Clinico Unversidad de Chile

    Independencia, Santiago Metropolitan, Santos Dumontt 999

  • Clinica Santa Maria

    Santiago, Santiago de Chile

Other trials in Chile

Netherlands2 sites

  • Vrije Universiteit Medical Centre (VUMC)

    HV Amsterdam, 1081

  • University Medical Centre Nijmegen (UMCN)

    Nijmegen, 6525

Other trials in Netherlands

Ireland1 site

  • Oncology Dept., University Floor, Belfast City Hospital

    Belfast, BT9 7AB

Other trials in Ireland

About this study

Official title: Phase 3 Randomized Study of TLK286 (Telcyta) Versus Doxil/Caelyx or Hycamtin as Third-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-1 (Assessment of Survival In Solid Tumors-1)]

The purpose of this study is to demonstrate superiority in survival in favor of TLK286 as compared to active control therapy with Doxil/Caelyx or Hycamtin in the intent-to-treat (ITT) populations.

Being tested
TLK286 HCl for injection, topotecan hydrochloride for injection, doxorubicin HCl liposome injection
Keywords
ovary
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TLK286 HCl for injectionDrug

  • topotecan hydrochloride for injectionDrug

  • doxorubicin HCl liposome injectionDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2003 (estimated)
  2. Study startJun 2003
  3. Primary completionDec 2006
  4. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
440 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00057720
Sponsor's protocol ID
TLK286.3017
Status last verified
May 2006
First submitted
7 Apr 2003
Last updated
25 Jul 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TLK286 HCl for injection, topotecan hydrochloride for injection and doxorubicin HCl liposome injection in people with Ovarian Neoplasms, run by Telik at 320 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 320 sites in United States, Argentina, Brazil, United Kingdom, Czechia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00057720.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2011.

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