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TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Doxil in Platinum Refractory or Resistant Ovarian Cancer

30. mai 2012 oppdatert av: Telik

Phase III Randomized Study of TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Liposomal Doxorubicin (Doxil) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-3]

The purpose of this research study is to determine if TLK286 given in combination with carboplatin is more effective than liposomal doxorubicin in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer, that is refractory or resistant to platinum chemotherapy.

Studieoversikt

Status

Fullført

Forhold

Neoplasmer i eggstokkene

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

244

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Arkansas
  - Little Rock, Arkansas, Forente stater, 72205
    - University of Arkansas for Medical Sciences
  - Little Rock, Arkansas, Forente stater, 72205
    - Little Rock Hematology Oncology
  - Little Rock, Arkansas, Forente stater, 72117
    - Little Rock Hematology Oncology
  - Little Rock, Arkansas, Forente stater, 72205
    - Arkansas Oncology Associates
  - Little Rock, Arkansas, Forente stater, 72207
    - Arkansas Oncology Associates
- California
  - Anaheim, California, Forente stater, 92807
    - Southern California Permanente Medical Group
  - Antioch, California, Forente stater, 94509
    - East Bay Oncology/Hematology Medical Associates, Inc.
  - Baldwin Park, California, Forente stater, 91706
    - Southern California Permanente Medical Group
  - Bellflower, California, Forente stater, 90706
    - Southern California Permanente Medical Group
  - Chula Vista, California, Forente stater, 91911
    - Marilyn Norton, M.D.
  - Concord, California, Forente stater, 94520
    - Bay Area Cancer Research Group, LLC
  - Concord, California, Forente stater, 94520
    - East Bay Oncology/Hematology Medical Associates, Inc.
  - Escondido, California, Forente stater, 92025
    - Southwest Cancer Care
  - Fontana, California, Forente stater, 92335
    - Southern California Permanente Medical Group
  - Fresno, California, Forente stater, 93710
    - California Oncology of the Central Valley
  - Harbor City, California, Forente stater, 90710
    - Southern California Permanente Medical Group
  - Hayward, California, Forente stater, 94545
    - Kaiser Permanente Medical Center
  - La Jolla, California, Forente stater, 92037
    - Gynecologic Oncology Associates
  - La Mesa, California, Forente stater, 91942
    - Cancer Center Oncology Medical Group
  - Loma Linda, California, Forente stater, 92354
    - Loma Linda University Medical Center
  - Loma Linda, California, Forente stater, 92354
    - LLU Faculty Medical Offices
  - Los Angeles, California, Forente stater, 90027
    - Southern California Permanente Medical Group
  - Los Angeles, California, Forente stater, 90095
    - David Geffen School of Medicine at UCLA
  - Los Angeles, California, Forente stater, 90034
    - Southern California Permanente Medical Group
  - Los Angeles, California, Forente stater, 90095
    - Bowyer Oncology Center
  - Los Angeles, California, Forente stater, 90095
    - OB/GYN Consult Suite
  - Montebello, California, Forente stater, 90640
    - Clinical Trials and Research Associates, Inc.
  - Montebello, California, Forente stater, 90640
    - Oncology Care Medical Associates
  - Montebello, California, Forente stater, 90640
    - Beverly Oncology and Imaging
  - Murrieta, California, Forente stater, 92562
    - Southwest Cancer Care
  - Newport Beach, California, Forente stater, 92663
    - Hoag Memorial Hospital Presbyterian
  - Newport Beach, California, Forente stater, 92663
    - Gynecologic Oncology Associates
  - Newport Beach, California, Forente stater, 92660
    - Newport Imaging Center
  - Oakland, California, Forente stater, 94611
    - Kaiser Permanente Medical Center
  - Oceanside, California, Forente stater, 92056
    - N. County Oncology Medical
  - Panorama City, California, Forente stater, 91402
    - Southern California Permanente Medical Group
  - Poway, California, Forente stater, 92064
    - Southwest Cancer Care
  - Riverside, California, Forente stater, 92505
    - Southern California Permanente Medical Group
  - Sacramento, California, Forente stater, 95825
    - Kaiser Permanente Medical Center
  - San Diego, California, Forente stater, 92123
    - Sharp Rees-Stealy
  - San Diego, California, Forente stater, 92123
    - Medical Oncology Associates
  - San Diego, California, Forente stater, 92123
    - Sharp Memorial Hospital - Investigational Pharmacy
  - San Francisco, California, Forente stater, 94115
    - Kaiser Permanente Medical Center
  - San Gabriel, California, Forente stater, 91776
    - Oncology Care Medical Associates
  - San Jose, California, Forente stater, 95119
    - Kaiser Permanente Medical Center
  - Santa Clara, California, Forente stater, 95051
    - Kaiser Permanente Medical Center
  - South San Francisco, California, Forente stater, 94080
    - Kaiser Permanente Medical Center
  - Vallejo, California, Forente stater, 94589
    - Kaiser Permanente Medical Center
  - Walnut Creek, California, Forente stater, 94596
    - Kaiser Permanente Medical Center
  - Walnut Creek, California, Forente stater, 94598
    - Diablo Valley Oncology & Hematology Medical Group, Inc.
  - Whittier, California, Forente stater, 90602
    - Oncology Care Medical Associates
  - Woodland Hills, California, Forente stater, 91367
    - Southern Permanente Medical Group
- Connecticut
  - Farmington, Connecticut, Forente stater, 06030
    - University of Connecticut Health Center/John Dempsey Hospital
- Florida
  - Boca Raton, Florida, Forente stater, 33486
    - The Center for Hematology-Oncology
  - Crystal River, Florida, Forente stater, 34428
    - Citrus Diagnostic Center
  - Crystal River, Florida, Forente stater, 34428
    - Citrus Hematology and Oncology Center
  - Crystal River, Florida, Forente stater, 34429
    - Citrus Hematology and Oncology Center
  - Delray Beach, Florida, Forente stater, 33484
    - The Center for Hematology-Oncology
  - Hollywood, Florida, Forente stater, 33021
    - GYN Oncology Associates, Inc.
  - Inverness, Florida, Forente stater, 34452
    - Citrus Hematology and Oncology Center
  - Inverness, Florida, Forente stater, 34452
    - Florida Wellcare Alliance, LC
  - Inverness, Florida, Forente stater, 34452
    - Citrus Memorial Hospital Radiology Dept.
  - Jacksonville, Florida, Forente stater, 32209
    - Shands Jacksonville Medical Center
  - Jupiter, Florida, Forente stater, 33458
    - Palm Beach Cancer Institute
  - Lecanto, Florida, Forente stater, 34461
    - Cancer and Blood Disease Center
  - Orlando, Florida, Forente stater, 32803
    - Florida Hospital
  - Orlando, Florida, Forente stater, 32804
    - Gynecology Oncology
  - Ormond Beach, Florida, Forente stater, 32174
    - Florida Hospital Memorial System
  - Ormond Beach, Florida, Forente stater, 32174
    - Florida Hospital Memorial Division - Cancer Care Center
  - Palm Beach Gardens, Florida, Forente stater, 33410
    - Palm Beach Cancer Institute
  - Pembroke Pines, Florida, Forente stater, 33028
    - GYN Oncology Associates, Inc.
  - Wellington, Florida, Forente stater, 33414
    - Palm Beach Cancer Institute
  - West Palm Beach, Florida, Forente stater, 33401
    - Palm Beach Cancer Institute
- Georgia
  - Atlanta, Georgia, Forente stater, 30342
    - Southeastern Gynecologic Oncology
  - Lawrenceville, Georgia, Forente stater, 30045
    - Southeastern Gynecologic Oncology
  - Marietta, Georgia, Forente stater, 30060
    - Southeastern Gynecologic Oncology
  - Riverdale, Georgia, Forente stater, 30274
    - Southeastern Gynecologic Oncology
  - Savannah, Georgia, Forente stater, 31404
    - Memorial Health University Medical Center
  - Tucker, Georgia, Forente stater, 30084
    - Southeastern Gynecologic Oncology
- Hawaii
  - Honolulu, Hawaii, Forente stater, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, Forente stater, 96819
    - Kaiser Permanente Hawaii
- Illinois
  - Flossmoor, Illinois, Forente stater, 60422
    - Joliet Oncology-Hematology Associates, Inc.
  - Joliet, Illinois, Forente stater, 60432
    - Joliet Oncology-Hematology Associates, Inc.
  - Joliet, Illinois, Forente stater, 60435
    - Joliet Oncology-Hematology Associates, Inc.
  - Kankakee, Illinois, Forente stater, 60901
    - Joliet Oncology-Hematology Associates, Inc.
  - Morris, Illinois, Forente stater, 60450
    - Joliet Oncology-Hematology Associates, Inc.
- Indiana
  - Elkhart, Indiana, Forente stater, 46514
    - Elkhart General Hospital
  - Indianapolis, Indiana, Forente stater, 46260
    - St. Vincent Hospital
  - LaPorte, Indiana, Forente stater, 46350
    - LaPorte Hospital
  - South Bend, Indiana, Forente stater, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, Forente stater, 46617
    - Saint Joseph's Regional Medical Center
- Kentucky
  - Louisville, Kentucky, Forente stater, 40202
    - James Graham Brown Cancer Center
  - Louisville, Kentucky, Forente stater, 40202
    - University Medical Center, Inc. DBA: U of L Hospital
- Louisiana
  - Covington, Louisiana, Forente stater, 70433
    - Hematology And Oncology Specialists, Llc
  - Metairie, Louisiana, Forente stater, 70002
    - OncRx (Pharmacy)
  - New Orleans, Louisiana, Forente stater, 70006
    - Hematology and Oncology Specialist
  - Shreveport, Louisiana, Forente stater, 71103
    - LSU Health Sciences Center
- Maine
  - Portland, Maine, Forente stater, 04102
    - Maine Medical Center
  - Portland, Maine, Forente stater, 04102
    - Maine Medical Center - Brighton Campus
  - Scarborough, Maine, Forente stater, 04074
    - Maine Medical Center - Scarborough Campus
- Maryland
  - Baltimore, Maryland, Forente stater, 21215
    - Sinai Hospital of Baltimore
  - Bethesda, Maryland, Forente stater, 20817
    - Center for Cancer and Blood Disorders, P. C.
- Massachusetts
  - Boston, Massachusetts, Forente stater, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, Forente stater, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, Forente stater, 02118
    - Boston Medical Center
  - Boston, Massachusetts, Forente stater, 02135
    - Caritas St. Elizabeth's Medical Center
  - Boston, Massachusetts, Forente stater, 02115
    - Dana Farber/Partners Cancer Care, Inc.
  - Boston, Massachusetts, Forente stater, 02118
    - Boston Medical Center - Center for Cancer and Blood Disorders
  - Waltham, Massachusetts, Forente stater, 02451
    - Perceptive Informatics, Inc.
- Michigan
  - Lansing, Michigan, Forente stater, 48912
    - Sparrow Health System
  - Niles, Michigan, Forente stater, 49120
    - Lakeland Hospital
  - Southfield, Michigan, Forente stater, 48075
    - Providence Cancer Institute and Hospital
  - St. Joseph, Michigan, Forente stater, 49085
    - Lakeland Hospital
- Minnesota
  - Duluth, Minnesota, Forente stater, 55805
    - Duluth Clinic
- Mississippi
  - Olive Branch, Mississippi, Forente stater, 38654
    - The Family Cancer Center
- Missouri
  - Columbia, Missouri, Forente stater, 65203
    - Ellis Fischel Cancer Center
  - St. Louis, Missouri, Forente stater, 63141
    - St. John's Mercy Medical Center
  - St. Louis, Missouri, Forente stater, 63117
    - Saint Louis University
  - St. Louis, Missouri, Forente stater, 63141
    - St. John's Mercy-David C. Pratt Cancer Center
- Montana
  - Billings, Montana, Forente stater, 59101
    - Deaconess Billings Clinic
- Nebraska
  - Omaha, Nebraska, Forente stater, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, Forente stater, 68122
    - Hematology & Oncology Consultants, PC
  - Scottsbluff, Nebraska, Forente stater, 69361
    - Regional West Medical Center
  - Scottsbluff, Nebraska, Forente stater, 69361
    - Odyssey Research
  - Scottsbluff, Nebraska, Forente stater, 69361
    - Horizons West Medical Group
  - Scottsbluff, Nebraska, Forente stater, 69361
    - The Women's Center of Western Nebraska
- New Hampshire
  - Lebanon, New Hampshire, Forente stater, 03756
    - Mary Hitchcock Memorial Hospital/Dartmouth-Hitchcock Medical Center
- New Jersey
  - Edison, New Jersey, Forente stater, 08818
    - JFK Medical Center
  - Edison, New Jersey, Forente stater, 08818
    - A. Richard Miskoff, DO, PA
  - Neptune, New Jersey, Forente stater, 07754
    - Jersey Shore University Medical Center
  - New Brunswick, New Jersey, Forente stater, 08901
    - The Cancer Institute of New Jersey
  - New Brunswick, New Jersey, Forente stater, 08901
    - Robert Wood Johnson University Hospital
  - West Long Branch, New Jersey, Forente stater, 07764
    - Jsumc Ob/Gyn
- New York
  - Babylon, New York, Forente stater, 11702
    - Gynecologic Oncology & Minimally Invasive Surgery
  - Cooperstown, New York, Forente stater, 13326
    - The Mary Imogene Bassett Hospital
  - East Islip, New York, Forente stater, 11730
    - Schwartz Gynecologic Oncology
  - Manhasset, New York, Forente stater, 11030
    - North Shore University Hospital
  - New City, New York, Forente stater, 10956
    - Hematology-Oncology Associates of Rockland
  - New Hyde Park, New York, Forente stater, 11040
    - Long Island Jewish Medical Center
  - Nyack, New York, Forente stater, 10960
    - The Union State Bank Cancer Center
- North Carolina
  - Asheville, North Carolina, Forente stater, 28816
    - Hope A Women's Cancer Center
  - Asheville, North Carolina, Forente stater, 28801
    - Asheville Radiology
  - Chapel Hill, North Carolina, Forente stater, 27599-7570
    - University of North Carolina at Chapel Hill
  - Charlotte, North Carolina, Forente stater, 28203
    - Carolinas Medical Center
  - Charlotte, North Carolina, Forente stater, 28204
    - Presbyterian Hospital
  - Charlotte, North Carolina, Forente stater, 28204
    - Presbyterian Gynecologic Oncology
  - Charlotte, North Carolina, Forente stater, 28204
    - Blumenthal Cancer Center
  - Charlotte, North Carolina, Forente stater, 28203
    - Inpatient Pharmacy
  - Winston Salem, North Carolina, Forente stater, 27103
    - Piedmont Hematology Oncology Associates
- North Dakota
  - Bismarck, North Dakota, Forente stater, 58501
    - Odyssey Research
  - Bismarck, North Dakota, Forente stater, 58501
    - Cancer Care Center - Medcenter One, Inc.
  - Bismarck, North Dakota, Forente stater, 58501
    - Cancer Treatment & Research Center - Mid Dakota Clinic, P. C.
  - Fargo, North Dakota, Forente stater, 58104
    - Odyssey Research
  - Fargo, North Dakota, Forente stater, 58103
    - Dakota Cancer Institute
- Ohio
  - Cincinnati, Ohio, Forente stater, 45219
    - University of Cincinnati Medical Center
  - Cincinnati, Ohio, Forente stater, 45219-0501
    - Barrett Cancer Center
  - Cincinnati, Ohio, Forente stater, 45219
    - UC Physician's Medical Arts Building
  - Cleveland, Ohio, Forente stater, 44111
    - Fairview Hospital Moll Pavilion
  - Columbus, Ohio, Forente stater, 43213
    - Mid Ohio Onc/Hem (East)
  - Columbus, Ohio, Forente stater, 43222
    - GOPSA
  - Columbus, Ohio, Forente stater, 43222
    - Mid Ohio Onc/Hem (West)
  - Dayton, Ohio, Forente stater, 45409
    - Miami Valley Hospital
  - Mayfield Heights, Ohio, Forente stater, 44124
    - Hillcrest Hospital/Cleveland Clinic Health System
  - Toledo, Ohio, Forente stater, 43606
    - The Toledo Hospital
  - Toledo, Ohio, Forente stater, 43606
    - ProMedica Health System
  - Toledo, Ohio, Forente stater, 43606
    - Garth Phibbs, M.D., FACOG
  - Westerville, Ohio, Forente stater, 43081
    - Mid Onio Onc/Hem (North)
- Oklahoma
  - Tulsa, Oklahoma, Forente stater, 74136
    - Cancer Care Associates
  - Tulsa, Oklahoma, Forente stater, 74104
    - Cancer Care Associates
- Oregon
  - Portland, Oregon, Forente stater, 97239
    - Oregon Health & Science University
  - Portland, Oregon, Forente stater, 97227
    - Kaiser Permanente Northwest Region
- Pennsylvania
  - Abington, Pennsylvania, Forente stater, 19001
    - Abington Memorial Hospital
  - Dunmore, Pennsylvania, Forente stater, 18512
    - Hematology & Oncology Associates of NEPA
  - Dunmore, Pennsylvania, Forente stater, 18512
    - Advance Imaging
  - Pittsburgh, Pennsylvania, Forente stater, 15213
    - Magee-Womens Hospital of UPMC
  - Scranton, Pennsylvania, Forente stater, 18510
    - Community Medical Center
  - Scranton, Pennsylvania, Forente stater, 18510
    - Moses Taylor Hospital
  - Scranton, Pennsylvania, Forente stater, 18508
    - Viewmont Medical Services
  - Scranton, Pennsylvania, Forente stater, 18510
    - Mercy Health Partners
  - Scranton, Pennsylvania, Forente stater, 18508
    - Hematology & Oncology Associates of NEPA
  - Upland, Pennsylvania, Forente stater, 19013
    - Associates in Hematology-Oncology, P.C.
- South Carolina
  - Charleston, South Carolina, Forente stater, 29407
    - Carolina Center of Gynecologic Oncology, PA
  - Charleston, South Carolina, Forente stater, 29401
    - Roper Hospital-Department of Radiology
  - Columbia, South Carolina, Forente stater, 29210
    - South Carolina Oncology
  - Greenville, South Carolina, Forente stater, 29605
    - Greenville Hospital System
  - Spartanburg, South Carolina, Forente stater, 29303
    - Spartanburg Regional Healthcare System
- South Dakota
  - Sioux Falls, South Dakota, Forente stater, 57104
    - Sioux Valley Clinic Oncology
  - Sioux Falls, South Dakota, Forente stater, 57104
    - Sioux Valley Hospital - North Center Radiology
  - Sioux Falls, South Dakota, Forente stater, 57104
    - Sioux Valley Clinic - Clinical Research Center
  - Sioux Falls, South Dakota, Forente stater, 57105
    - Sioux Valley Clinic OBGYN, Ltd.
- Tennessee
  - Bartlett, Tennessee, Forente stater, 38133
    - The Family Cancer Center
  - Chattanooga, Tennessee, Forente stater, 37403
    - Chattanooga GYN Oncology
  - Chattanooga, Tennessee, Forente stater, 37404
    - Parkridge Medical Center
  - Chattanooga, Tennessee, Forente stater, 37403
    - Baroness Erlander Hospital
  - Collierville, Tennessee, Forente stater, 38017
    - The Family Cancer Center
  - Memphis, Tennessee, Forente stater, 38119
    - The Family Cancer Center
- Texas
  - Arlington, Texas, Forente stater, 76012
    - Arlington Cancer Center
  - Dallas, Texas, Forente stater, 75231
    - Texas Cancer Associates
  - Dallas, Texas, Forente stater, 75230
    - Center for Oncology Research and Treatment, PA
  - Plano, Texas, Forente stater, 75093
    - Texas Cancer Associates
  - Richardson, Texas, Forente stater, 75080
    - Center for Oncology Research and Treatment, PA
- Virginia
  - Danville, Virginia, Forente stater, 24541
    - Danville Hematology and Oncology, Inc.
  - Richmond, Virginia, Forente stater, 23235
    - VCU Health System at Stony Point
  - Richmond, Virginia, Forente stater, 23298
    - VCU Health System-Dalton Oncology Clinic, North Hospital
  - Roanoke, Virginia, Forente stater, 24014
    - Carilion GYN Oncology Associates
- Washington
  - Aberdeen, Washington, Forente stater, 98520
    - Western Washington Oncology, Inc., P.S.
  - Centralia, Washington, Forente stater, 98531
    - Western Washington Oncology, Inc., P. S.
  - Covington, Washington, Forente stater, 98042-4951
    - Covington MultiCare - Oncology Clinic
  - Gig Harbor, Washington, Forente stater, 98335
    - Gig Harbor Medical Oncology
  - Lacey, Washington, Forente stater, 98503
    - Western Washington Oncology, Inc., P.S.
  - Shelton, Washington, Forente stater, 98584
    - Western Washington Oncology, Inc., P.S.
  - Tacoma, Washington, Forente stater, 98405
    - Allenmore Hospital - Hematology Oncology Clinic
  - Tacoma, Washington, Forente stater, 98405
    - MultiCare Health System - Medical Oncology
- Wisconsin
  - Chippewa Falls, Wisconsin, Forente stater, 54729
    - Marshfield Clinic - Chippewa Falls Center
  - Eau Claire, Wisconsin, Forente stater, 54701
    - Marshfield Clinic Cancer Care - Regional Cancer Center - Sacred Heart Hospital
  - Marshfield, Wisconsin, Forente stater, 54449
    - Marshfield Clinic
  - Minocqua, Wisconsin, Forente stater, 54548
    - Marshfield Clinic - Lakeland Center
  - Rice Lake, Wisconsin, Forente stater, 54868
    - Marshfield Clinic - Indianhead Center
  - Stevens Point, Wisconsin, Forente stater, 54481
    - St. Michael's Hospital
  - Wausau, Wisconsin, Forente stater, 54401
    - Marchfield Clinic - Wausau Center
  - Weston, Wisconsin, Forente stater, 54476
    - Marshfield Clinic Weston Center
  - Wisconsin Rapids, Wisconsin, Forente stater, 54494
    - Marshfield Clinic - Wisconsin Rapids Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

Are a woman 18 years of age or older
Have histologically or cytologically confirmed epithelial cancer of the ovary or fallopian tube, or primary peritoneal cancer
Have platinum refractory or resistant cancer
Measurable disease according to radiographic RECIST criteria with documented tumor progression

Exclusion Criteria:

Had treatment with first-line chemotherapy other than platinum-based regimens (carboplatin or cisplatin)
Have clinically significant cardiac disease
Have any sign of intestinal obstruction interfering with nutrition at the time of study entry
Are pregnant or lactating
Had prior treatment with liposomal doxorubicin for ovarian cancer
Had prior treatment with TLK286

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Ingen (Open Label)

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Eksperimentell: TLK286 in Combination with Carboplatin	Legemiddel: TLK286 in Combination with Carboplatin Experimental Arm
Aktiv komparator: Doxorubisin HCl Liposome Injection	Legemiddel: Doxorubicin HCl Liposome Injection Active Comparator

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Study Objectives Tidsramme: Every 8 Weeks	To demonstrate superiority in the objective response rate (ORR) of TLK286 in combination with carboplatin as compared to active control therapy with liposomal doxorubicin	Every 8 Weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Telik

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2004

Primær fullføring (Faktiske)

1. juli 2008

Studiet fullført (Faktiske)

1. juli 2008

Datoer for studieregistrering

Først innsendt

4. februar 2005

Først innsendt som oppfylte QC-kriteriene

4. februar 2005

Først lagt ut (Anslag)

7. februar 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

31. mai 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. mai 2012

Sist bekreftet

1. juni 2006

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Eggstokk

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

TLK286.3024

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Desmoid fibromatose | Desmoid | Desmoid fibromatose i huden | Desmoid Neoplasm of Chest Wall | Desmoid-svulst forårsaket av somatisk mutasjon | Aggressive fibromatoser | Fibromatose Desmoid

Israel
Chongqing Precision Biotech Co., Ltd

Rekruttering

Klinisk utprøving av CD123-målrettet CAR-NK-terapi for tilbakefall/refraktær AML eller BPDCN

AML (akutt myeloid leukemi) | BPDCN (blastisk Plasmacytoid Dendritic Cell Neoplasm)

Kina
Children's Oncology Group
National Cancer Institute (NCI)

Rekruttering

Aktiv overvåking, bleomycin, etoposid, karboplatin eller cisplatin ved behandling av pediatriske og voksne pasienter med kimcellesvulster

Ondartet kimcellesvulst | Kimcelletumor | Ekstrakraniell kimcellesvulst i barndommen | Ekstragonadal embryonal karsinom | Ondartet ovarieteratom | Stadium I Ovarial Choriocarcinoma | Fase I Ovarial Embryonal Carcinoma AJCC v6 og v7 | Stage I Eggstokkeplommesekktumor AJCC v6 og v7 | Stage I Testikkelkoriokarsinom... og andre forhold

Forente stater, Canada, Japan, Australia, Puerto Rico, New Zealand, Storbritannia, Saudi-Arabia, India
Beijing Biotech

Rekruttering

Adaptive dobbeltmål CAR-T-celler for tilbakevendende eller refraktære hematologiske maligniteter (ADAPT-HEM)

Perifert T-celle lymfom | T-lymfoblastisk lymfom | Relapset/Refraktær B-celle akutt lymfatisk leukemi | Resistent/refraktær B-celle non-Hodgkin lymfom eller CLL/SLL | Relapserende/Refraktær Multipl Myelom eller Plasmacelleleukemi | Relapset/Refraktær Akutt Myeloid Leukemi, Høyrisiko Myelodysplastisk... og andre forhold

Kina
Prelude Therapeutics
BeiGene

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En studie av PR2527 hos deltakere med residiverende/refraktære hematologiske maligniteter

Marginal sone lymfom | Akutt myeloid leukemi (AML) | Kronisk myelomonocytisk leukemi (CMML) | Myelodysplastisk syndrom (MDS) | T-celle lymfom | Mantelcellelymfom (MCL) | Diffust storcellet B-celle lymfom (DLBCL) | Richters syndrom | Myeloide maligniteter | Aggressiv B-celle non-Hodgkins lymfom (NHL) | Kronisk... og andre forhold

Forente stater, Canada, Australia, Frankrike, Italia, Storbritannia, Sør -Korea, Tyskland, Polen, Sveits
National Cancer Institute (NCI)

Avsluttet

EF5 og Motexafin Lutetium i påvisning av svulstceller hos pasienter med abdominal eller ikke-småcellet lungekreft

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Forente stater

Kliniske studier på TLK286 in Combination with Carboplatin

Emory University
National Cancer Institute (NCI)

Rekruttering

Høydose strålebehandling med Pembrolizumab og kjemoterapi for behandling av pasienter med PD-L1 positiv metastatisk trippel negativ brystkreft

Anatomisk stadium IV brystkreft AJCC v8 | Metastatisk trippelnegativt brystkarsinom

Forente stater
Children's Oncology Group
National Cancer Institute (NCI)

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Kombinasjonskjemoterapi, autolog stamcelletransplantasjon og/eller strålebehandling ved behandling av unge pasienter med ekstraokulært retinoblastom

Ekstraokulært retinoblastom

Forente stater, Canada, Australia, Brasil, Argentina, Egypt
QuantumLeap Healthcare Collaborative

Rekruttering

I-SPY PRØVE: Neoadjuvant og personlig tilpassede nye midler for å behandle brystkreft (I-SPY)

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TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Doxil in Platinum Refractory or Resistant Ovarian Cancer

Phase III Randomized Study of TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Liposomal Doxorubicin (Doxil) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-3]

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Kliniske studier på Neoplasmer i eggstokkene

Kliniske studier på TLK286 in Combination with Carboplatin

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