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Epithelial Ovarian CancerPhase 2NCT01666444

VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

A Phase 2 study testing pegylated liposomal doxorubicin (PLD) and VTX-2337 in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Celgene at 136 sites in United States.

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 compare the overall survival of patients treated with VTX-2337 + pegylated liposomal doxorubicin (PLD) versus those treated with PLD alone in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
pegylated liposomal doxorubicin (PLD) and VTX-2337
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
297 participants
Where
136 sitesUnited States
Study dates
31 Oct 2012to 31 Jul 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
  • Patients with the following histologic cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial adenocarcinoma, transitional cell carcinoma, malignant Brenner's tumor or adenocarcinoma not otherwise specified.
  • Patient must have measurable disease as defined by RECIST 1.1.
  • Patients must have received treatment with a platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment.
  • Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease.
  • Patients are allowed to have received, but are not required to have received, biologic/targeted therapy (e.g., bevacizumab and/or PARP inhibitor) as part of their primary treatment regimen or for management of recurrent or persistent disease.
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  • Patients must have platinum-resistant disease, defined as having a platinum-free interval (PFI) of < 12 months after first- or second-line platinum-based chemotherapy, or having disease progression while receiving second-line platinum-based chemotherapy.
  • Patients must have adequate bone marrow, renal, hepatic, and neurologic functions as defined by the following:
  • Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mm3. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets ≥ 100,000/mm3. Hemoglobin ≥ 9 g/dL.
  • Renal function: creatinine ≤ 1.5 x institutional upper limit normal (ULN).
  • Hepatic function: bilirubin < 1.2 mg/dL, SGOT (AST) and SGPT (ALT) ≤ 3.0 x ULN and alkaline phosphatase ≤ 2.5 x ULN.
  • Patients must have recovered from effects of recent surgery, radiotherapy or chemotherapy:
  • Patients should be free of active infection requiring parenteral antibiotics.
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
  • Any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted agents and immunologic agents, must be discontinued at least three weeks prior to registration.
  • Any prior radiation therapy must be completed at least four weeks prior to registration.
  • Patients must have a GOG performance status of 0 or 1.
  • Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.
  • Patients must meet the entry requirements and undergo the baseline procedures.
  • Patients must have signed an IRB-approved informed consent form and authorization permitting release of personal health information.

Who cannot join

  • Patients who have had treatment with VTX-2337, doxorubicin, PLD, or any other anthracycline.
  • Patients who have received an investigational agent < 30 days prior to registration.
  • Patients who have received oral or parenteral corticosteroids < 2 weeks prior to registration or who require ongoing systemic immunosuppressive therapy for any reason.
  • Patients with active autoimmune disease. "Active" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of the other malignancy being present within the last three years.
  • Patients who have received prior radiotherapy OTHER THAN for the treatment of ovarian, fallopian tube or primary peritoneal cancer within the last three years are excluded.
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  • Patients who have received prior chemotherapy OTHER THAN for the treatment of ovarian, fallopian tube or primary peritoneal cancer within the last three years are excluded.
  • Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.
  • Patients with clinically significant cardiovascular disease.
  • Patients who are pregnant or nursing.
  • Patients under the age of 18.
  • Patients with clinical symptoms or signs of gastrointestinal obstruction and/or who require parenteral hydration or nutrition.

Trial locations and contacts

136 sites in 1 country.

136 sites in 1 country

United States136 sites

  • Abington Memorial Hospital; Hanjani Institute for Gynecologic Oncology

    Abington, Pennsylvania, 19001

  • Summa Health System

    Akron, Ohio, 44304

  • Women's Cancer Care Associates

    Albany, New York, 12208

  • Southwest Gynecologic Oncology Associates

    Albuquerque, New Mexico, 87016

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • McFarland Clinic

    Ames, Iowa, 50010

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Mid Atlantic Pelvic Surgery Associates

    Annandale, Virginia, 22003

  • Hope Women's Cancer Center

    Asheville, North Carolina, 28806

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Georgia Regents University

    Augusta, Georgia, 30912

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Johns Hopkins Medical Institution

    Baltimore, Maryland, 21287

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Saint Joseph Medical Center

    Burbank, California, 91505

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805

  • Alamance Regional Cancer Center

    Burlington, North Carolina, 27215

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Medical Center / Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Northwestern University - Robert H. Lurie Comprehensive Cancer Center

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Fairview Hospital Moll Pavilion Cancer Center

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ellis Fischel Cancer Center - University of Missouri

    Columbia, Missouri, 65211

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Carolinas Medical Center - Northeast

    Concord, North Carolina, 28025

  • Minnesota Oncology Coon Rapids Clinic

    Coon Rapids, Minnesota, 55433

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Karmanos Cancer Institute - Wayne State University

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • Grand Rapids Clinical Oncology

    Grand Rapids, Michigan, 49503

  • Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Gynecologic Oncology of West Michigan

    Grand Rapids, Michigan, 49546

  • Green Bay Oncology at St. Vincent's Hospital

    Green Bay, Wisconsin, 54301

  • St Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Bon Secours St. Francis Hospital

    Greenville, South Carolina, 29601

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • St. Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Kaiser Permanente Medical Center

    Hayward, California, 94545

  • Sudarshan K. Sharma, MD, LTD

    Hinsdale, Illinois, 60521

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • The Methodist Hospital

    Houston, Texas, 77030

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202

  • St. Vincent Gynecologic Oncology

    Indianapolis, Indiana, 46260

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • St. Dominic-Jackson Memorial Hospital

    Jackson, Mississippi, 32916

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Women's Cancer Center at Kettering Medical Center

    Kettering, Ohio, 45429

  • Monter Cancer Center

    Lake Success, New York, 11042

  • Memorial Medical Center

    Las Cruces, New Mexico, 88011

  • Women's Cancer Care Center of Nevada

    Las Vegas, Nevada, 89169

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Winthrop P. Rockefeller Cancer Institute - University of Arkansas

    Little Rock, Arkansas, 72205

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • Central Georgia Gynecologic Oncology

    Macon, Georgia, 31201

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53792

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Holy Family Memorial Medical Center

    Manitowoc, Wisconsin, 54221

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Hillcrest Hospital - Cleveland Clinic

    Mayfield Heights, Ohio, 44124

  • Lake University Seidman Cancer Center

    Mentor, Ohio, 44060

  • Aurora St. Luke's Medical Center Gynecologic Oncology

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55404

  • Mercy Health Partners - Mercy Campus

    Muskegon, Michigan, 49444

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Yale - New Haven Hospital

    New Haven, Connecticut, 06520

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • NYU Langone Medical Center - Cancer Institute

    New York, New York, 10016

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Kaiser Permanente Medical Center

    Oakland, California, 94611

  • Peggy and Charles Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • MD Anderson Cancer Center - Orlando

    Orlando, Florida, 32806

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Hillman Cancer Center - University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • Reed City Hospital - Spectrum Health

    Reed City, Michigan, 49677

  • Virginia Gynecology Oncology

    Richmond, Virginia, 23229

  • Carilion Clinic Gynecological Oncology

    Roanoke, Virginia, 24016

  • Kaiser Permanente Medical Center

    Roseville, California, 95661

  • Sutter Cancer Center

    Sacramento, California, 95816

  • Kaiser Permanente Medical Center

    Sacramento, California, 95825

  • Metro Minnesota Clinical Oncology Program

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Frauenshuh Cancer Center

    Saint Louis Park, Minnesota, 55426

  • Minnesota Oncology Hematology - St. Paul Cancer Center

    Saint Paul, Minnesota, 55102

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112

  • Kaiser Permanente Medical Center

    San Francisco, California, 94115

  • Kaiser Permanente Medical Center

    San Jose, California, 95119

  • Kaiser Permanente Medical Center

    Santa Clara, California, 95051

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • St. Joseph's - Candler Gynecologic Oncology

    Savannah, Georgia, 31405

  • Maine Medical Partners Women's Health

    Scarborough, Maine, 04074

  • Pacific Gynecology Specialists

    Seattle, Washington, 98104

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Northwest Hospital - UW Medicine

    Seattle, Washington, 98133

  • Women's Cancer Care of Seattle

    Seattle, Washington, 98133

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Kaiser Permanente Medical Center

    South San Francisco, California, 94080

  • Gibbs Cancer Center

    Spartanburg, South Carolina, 29303

  • Women's Cancer Associates

    St. Petersburg, Florida, 33701

  • Stanford University School of Medicine

    Stanford, California, 94305

  • Gynecologic Oncology of Central New York - SUNY Upstate

    Syracuse, New York, 13057

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Tulsa Cancer Institute

    Tulsa, Oklahoma, 74146

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Kaiser Permanente Medical Center

    Vallejo, California, 94586

  • Kaiser Permanente Medical Center

    Walnut Creek, California, 94596

  • Aspirus Regional Cancer Center

    Wausau, Wisconsin, 54401

  • Reading Hospital (McGlinn Family Regional Cancer Center)

    West Reading, Pennsylvania, 19611

  • University of Kansas Medical Center

    Westwood, Kansas, 66205

  • Wake Forest University Health Science

    Winston-Salem, North Carolina, 27157

  • Woodbury Clinic - CornerStone Medical Specialty Centre

    Woodbury, Minnesota, 55125

  • University of Massachusetts Memorial Healthcare

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Study of VTX-2337 in Combination With Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

The purpose of this study is to compare the overall survival of patients treated with VTX-2337 + pegylated liposomal doxorubicin (PLD) versus those treated with PLD alone in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer.

VTX-2337, a small molecule agonist of Toll-like Receptor 8 (TLR8), activates multiple components of the innate immune system and is being developed as a novel therapeutic agent for use in oncology. Experimental data obtained in an animal model of ovarian cancer supports the combination of VTX-2337 with PLD. In this model, the combination of VTX-2337 and PLD resulted in a significant reduction in tumor growth compared to either agent alone and an increase in the number of T lymphocytes infiltrating the tumor. The combination of PLD and VTX-2337 has been tested in a small number of women with ovarian cancer in a Phase 1b study and appears to be generally well-tolerated.

Read the detailed description

OBJECTIVES

Primary Objectives:

  • To compare the overall survival (OS) of patients treated with VTX-2337 + PLD versus those treated with PLD alone in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer.
  • To compare the progression-free survival (PFS) between the two treatment groups using Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST).

Secondary Objectives:

  • To compare the progression-free survival (PFS) between the two treatment groups using Response Evaluation Criteria In Solid Tumors (RECIST 1.1).
  • To compare the nature, frequency and severity of drug-related adverse events (AEs) between the two treatment groups.

Exploratory Objectives:

  • To compare the best overall response rate (ORR) and duration of response (based on the probability of being in response function [PBRF]) between the two treatment groups using irRECIST and RECIST 1.1.
  • To compare the disease control rate (DCR) between the two treatment groups using irRECIST and RECIST 1.1.
  • To assess the impact of immune status and response on the clinical effects (OS, PFS, DCR, ORR, PBRF, AEs) of study treatment.
  • To assess the effect of TLR8 polymorphisms and BRCA1/BRCA2 mutations on the clinical effects (OS, PFS, DCR, ORR, PBRF, AEs) of study treatment.
  • To assess the effect of immune cell subsets, as measured by immunohistochemistry and micro RNA in primary tumor tissue (e.g. immune score), on the clinical effects (OS, PFS, DCR, ORR, PBRF, AEs) of study treatment.
  • To assess whether the presence of autoantibodies to tumor-derived proteins are predictive of the clinical effects (OS, PFS, DCR, ORR, PBRF, AEs) of study treatment.

OUTLINE:

This is Phase 2 multicenter clinical study to evaluate the efficacy and safety of the combination of VTX-2337 + PLD compared to PLD + Placebo.

The dosing schedule will be the same for both treatment arms, and will be based on a 28-day cycle. The starting dose schedule is PLD on Day 1 plus VTX-2337 or placebo on Day 3, Day 10, and Day 17 for the first 4 cycles. Starting with cycle 5, the dose regimen will be PLD on Day 1 plus VTX-2337 or placebo on Day 3.

Blood samples are collected periodically during cycle 1 for pharmacodynamics, pharmacogenomics, and other research studies.

Patients will receive therapy until disease progression based on Immune-Related RECIST or until adverse effects prohibit further therapy. Following treatment completion, all patients will be followed with physical exams and histories every three months for the first two years, and then every six months for the next three years, and then

Being tested
pegylated liposomal doxorubicin (PLD), VTX-2337, Placebo
Keywords
recurrent epithelial ovarian cancer, recurrent fallopian tube cancer, recurrent primary peritoneal cavity cancer, ovarian serous cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian undifferentiated adenocarcinoma, ovarian clear cell cystadenocarcinoma, ovarian mixed epithelial carcinoma, Brenner tumor
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Brenner Tumor

What participants receive

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

  • pegylated liposomal doxorubicin (PLD)Drug

    Also called Doxil, Lipodox

  • VTX-2337Drug

    TLR8 Agonist

  • PlaceboDrug

Study groups in NCT01666444
Study groupRoleWhat they receive
PLD 40 mg/m2 plus VTX-2337ExperimentalThe dosing schedule will be be based on a 28-day cycle. The starting dose schedule is PLD on Day 1 plus VTX-2337 on Day 3, Day 10, and Day 17 for the first 4 cycles. Starting with cycle 5, the dose regimen will be PLD on Day 1 plus VTX-2337 on Day 3 only, without additional doses of VTX-2337 on Days 10 and Day 17.
Receives: Drug: pegylated liposomal doxorubicin (PLD); Drug: VTX-2337
PLD 40 mg/m2 plus placeboActive comparatorThe dosing schedule will be based on a 28-day cycle. The starting dose schedule is PLD on Day 1 plus placebo on Day 3, Day 10, and Day 17 for the first 4 cycles. Starting with cycle 5, the dose regimen will be PLD on Day 1 plus placebo on Day 3 only.
Receives: Drug: pegylated liposomal doxorubicin (PLD); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Comparison of duration of survival between the 2 treatment groups

    Measured: Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact.

Secondary outcomes (2)

  1. Progression-free Survival (PFS)

    Comparison of PFS between the 2 treatment groups

    Measured: Progression-free survival is measured from enrollment and randomization on the study until first indication of progression based on irRECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment.

  2. Frequency and Severity of Adverse Events (AEs)

    An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can be unfavorable and unintended sign, symptom, or disease which is temporally associated with the use of investigational product (IP), whether or not considered related to the IP. A serious AE = an AE occurring at any dose that: • Results in death • Is life- threatening • Requires or prolongs existing inpatient hospitalization • Results in persistent or significant disability/incapacity • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to IP and graded the severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0: Grade (GR) 1 = Mild; asymptomatic or mild symptoms; GR 2 = Moderate (minimal, local or noninvasive intervention indicated); GR 3 = Severe or medically significant; GR 4 = Life-threatening; GR 5 = Death

    Measured: Assessed during each cycle of therapy and within 30 days after the last cycle of therapy

Timeline

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

  1. First posted16 Aug 2012 (estimated)
  2. Study start31 Oct 2012
  3. Primary completion31 Jul 2016
  4. Study completion31 Jul 2016

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01666444
Sponsor's protocol ID
GOG-3003
Status last verified
Sep 2019
First submitted
10 Aug 2012
Last updated
26 Sep 2019
Data monitoring committee
Yes

Publications

  • Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.

    PubMed 37407274

  • Monk BJ, Brady MF, Aghajanian C, Lankes HA, Rizack T, Leach J, Fowler JM, Higgins R, Hanjani P, Morgan M, Edwards R, Bradley W, Kolevska T, Foukas P, Swisher EM, Anderson KS, Gottardo R, Bryan JK, Newkirk M, Manjarrez KL, Mannel RS, Hershberg RM, Coukos G. A phase 2, randomized, double-blind, placebo- controlled study of chemo-immunotherapy combination using motolimod with pegylated liposomal doxorubicin in recurrent or persistent ovarian cancer: a Gynecologic Oncology Group partners study. Ann Oncol. 2017 May 1;28(5):996-1004. doi: 10.1093/annonc/mdx049.

    PubMed 28453702

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pegylated liposomal doxorubicin (PLD) and VTX-2337 in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Celgene at 136 sites in United States.

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 20 inclusion and 12 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 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 136 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Overall Survival (time frame: Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01666444, which also lists 2 linked publications.

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 26 Sep 2019.

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