Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)

November 26, 2013 updated by: Telik

Phase 3 Randomized Study of TLK286 (Telcyta®) in Combination With Liposomal Doxorubicin (Doxil/Caelyx)Versus Liposomal Doxorubicin (Doxil/Caelyx) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)

The purpose of this research study is to determine if Telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone 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.
Terminated

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.

Detailed Description

This is a randomized, open label, multicenter, multinational Phase 3 study of TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) as compared to the active control therapy with liposomal doxorubicin (Doxil/Caelyx) as second line therapy in patients with platinum refractory or resistant recurrent ovarian cancer. Patients will be randomly assigned to receive either TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) or active control liposomal doxorubicin (Doxil/Caelyx).

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

  • Belgium
      • Antwerpen, Belgium, B-2020
        • Algemeen Ziekenhuis Middelheim
      • Kortrijk, Belgium, B-8500
        • A.Z. Groeninge Oncologish Centrum
      • Leuven, Belgium, B3000
        • Universitaire Ziekenhuizen Leuven Dienst Oncologie
  • Brazil
    • MG
      • Belo Horizonte, MG, Brazil, 30190-130
        • Hospital Vera Cruz-Instituto de Oncologia
    • Sao Paulo
      • Cerqueria Cesar, Sao Paulo, Brazil, 05403-010
        • Centr de Oncologia do Instituto de Radiologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
      • Rua Dona Siilveria, Sao Paulo, Brazil, 17210-080
        • Fundacao Hospital Amaral Carvalho
  • United Kingdom
    • England
      • London, England, United Kingdom, SE19RT
        • Guy's & St. Thomas Cancer Centre
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School
  • United States
    • Arizona
      • Casa Grande, Arizona, United States, 85222
        • Desert Oasis Cancer Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, United States, 72205
        • Hematology Oncology Services of Arkansas
    • California
      • Antioch, California, United States, 94509
        • East Bay Medical Oncology/Hematology Medical Associates, Inc.
      • Concord, California, United States, 94520
        • Bay Area Cancer Research Group, LLC
      • Concord, California, United States, 94520
        • East Bay Medical Oncology/Hematology Medical Associates
      • Fresno, California, United States, 93710
        • California Oncology of the Central Valley
      • Newport Beach, California, United States, 92663
        • Women's Cancer Research Foundation
      • Poway, California, United States, 92064
        • Southwest Cancer Care
      • Rancho Mirage, California, United States, 92270
        • Desert Hematology Oncology Medical Group
      • San Diego, California, United States, 92120
        • Southern California Permanente Medical Group
      • San Leandro, California, United States, 94578
        • East Bay Medical Oncoogy/Hematology Medical Associates, Inc.
      • Walnut Creek, California, United States, 94598
        • Diablo Valley Oncology & Hematology Medical Group, Inc.
    • Florida
      • Hollywood, Florida, United States, 33020
        • Gynecologic Oncology Associates, Inc
      • Jacksonville, Florida, United States, 32209
        • Shands Jacksonville Medical Center
      • Jacksonville, Florida, United States, 32209
        • University of Florida College of Medicine-Jacksonville
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
      • Orlando, Florida, United States, 32804
        • Florida Hospital
      • Pembroke Pines, Florida, United States, 33028
        • Gynecologic Oncology Associates, Inc
    • Georgia
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente Moanalua Medical Center
    • Illinois
      • Flossmoor, Illinois, United States, 60422
        • Flossmoor Cancer Care (JOHA DBA)
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates, Ltd.
      • Joliet, Illinois, United States, 60432
        • Joliet Oncology-Hematology Associates
      • Kankakee, Illinois, United States, 60901
        • Kankakee Cancer Center (JOHA DBA)
      • Morris, Illinois, United States, 60450
        • Joliet Oncology-Hematology Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Gynecologic Oncology
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Central Baptist Hospital
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Hematology And Oncology Specialists, Llc
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Sciences Center
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Arch Medical Services
    • Nebraska
      • Omaha, Nebraska, United States, 68122
        • Hematology & Oncology Consultants P.C.
      • Scottsbluff, Nebraska, United States, 69361
        • Horizon's West Medical Group
      • Scottsbluff, Nebraska, United States, 69361
        • The Women's Center of Western Nebraska
    • New York
      • Babylon, New York, United States, 11702
        • Schwaartz Gynecologic Oncology, PLLC
      • Cooperstown, New York, United States, 13326
        • The Mary Imogene Bassett Hospital
      • Lake Success, New York, United States, 11042
        • Monter Cancer Center
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28816
        • Hope A Women's Cancer Center
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Medical Center
      • Charlotte, North Carolina, United States, 28204
        • Presbyterian Hospital
      • Charlotte, North Carolina, United States, 28204
        • Blumenthal Cancer Center
      • Lexington, North Carolina, United States, 27292
        • Piedmont Hematology Oncology Associates-Lexington Satellite
      • Winston Salem, North Carolina, United States, 27103
        • Piedmont Hematology Oncology Associates
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Dakota Cancer Institute/Dakota Clinic Ltd.
    • Ohio
      • Columbus, Ohio, United States, 43222
        • Gynecologic Oncology & Pelvic Surgery Associates
      • Toledo, Ohio, United States, 43606
        • The Toledo Hospital
      • Toledo, Ohio, United States, 43606
        • Garth Phibbs, M.D., FACOG
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Oregon Health & Science University
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente NW, Oncology/Hematology
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Dunmore, Pennsylvania, United States, 18512
        • Hematology & Oncology Associates of NEPA
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee Women's Hospital of UPMC
      • Upland, Pennsylvania, United States, 19013
        • Associates in Hematolog-Oncology, P.C.
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Carolina Center of Gynecologic Oncology
      • Columbia, South Carolina, United States, 29210
        • South Carolina Oncology Associates
      • Columbia, South Carolina, United States, 29210
        • Palmetto Health Alliance-Richland
    • Texas
      • Arlington, Texas, United States, 76012
        • Arlington Cancer Center
      • Trophy Club, Texas, United States, 76262
        • Arlington Cancer Center
    • Virginia
      • Danville, Virginia, United States, 24541
        • Danville Hematology & Oncology, Inc.
      • Roanoke, Virginia, United States, 24014
        • Carilion GYN Oncology Associates

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 or primary peritoneal cancer
  • Have platinum refractory or resistant cancer
  • Measurable disease according to radiographic RECIST criteria progression

Exclusion Criteria:

  • Had treatment with first-line chemotherapy other than a platinum-containing regimen
  • Have clinically significant cardiac disease
  • Have any sign of intestinal obstruction interfering with nutrition
  • Are pregnant or lactating
  • Had prior treatment with liposomal doxorubicin
  • Had prior treatment with Telcyta

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: Telcyta + Liposomal Doxorubicin
Telcyta at 1000 mg/m2 followed by Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
Drug: Telcyta
Day 1 of 28 day Cycle.
Other Names:
  • TLK286
  • canfosfamide
Drug: Liposomal Doxorubicin
Day 1 of 28 Day Cycle. 50 mg/m2
Other Names:
  • Caelyx
  • Doxil
Active Comparator: Liposomal Doxorubicin
Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
Drug: Liposomal Doxorubicin
Day 1 of 28 Day Cycle. 50 mg/m2
Other Names:
  • Caelyx
  • Doxil

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
Time Frame
To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin
Time Frame: Once 244 planned pts. received at least 2 cycles of study treatment(s)
Once 244 planned pts. received at least 2 cycles of study treatment(s)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To evaluate and compare the safety profile of each treatment arm
Time Frame: Any patient who received 1 dose of study treatment(s) will be evaluable for safety.
Any patient who received 1 dose of study treatment(s) will be evaluable for safety.

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gail L. Brown, MD, MBA, Telik

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
May 1, 2006

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.
December 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.
December 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).
July 6, 2006

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.
July 10, 2006

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.
July 11, 2006

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.
November 27, 2013

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.
November 26, 2013

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.
November 1, 2013

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.
  • TLK286.3025

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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