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

May 30, 2012 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
244

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TLK286 in Combination with Carboplatin
Drug: TLK286 in Combination with Carboplatin
Experimental Arm
Active Comparator: Doxorubisin HCl Liposome Injection
Drug: Doxorubicin HCl Liposome Injection
Active Comparator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Study Objectives
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Telik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TLK286.3024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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