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

September 24, 2019 updated by: Celgene

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.

Study Overview

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

Study Type

Interventional

Enrollment (Actual)

297

Phase

  • Phase 2

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

    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Winthrop P. Rockefeller Cancer Institute - University of Arkansas
    • California
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center
      • Hayward, California, United States, 94545
        • Kaiser Permanente Medical Center
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center
      • Oakland, California, United States, 94611
        • Kaiser Permanente Medical Center
      • Roseville, California, United States, 95661
        • Kaiser Permanente Medical Center
      • Sacramento, California, United States, 95816
        • Sutter Cancer Center
      • Sacramento, California, United States, 95825
        • Kaiser Permanente Medical Center
      • San Francisco, California, United States, 94115
        • Kaiser Permanente Medical Center
      • 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
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
      • Vallejo, California, United States, 94586
        • Kaiser Permanente Medical Center
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • Hartford, Connecticut, United States, 06105
        • St. Francis Hospital and Medical Center
      • New Britain, Connecticut, United States, 06050
        • The Hospital of Central Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale - New Haven Hospital
    • Florida
      • Orlando, Florida, United States, 32806
        • MD Anderson Cancer Center - Orlando
      • Saint Petersburg, Florida, United States, 33701
        • Women's Cancer Associates
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Augusta, Georgia, United States, 30912
        • Georgia Regents University
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
      • Macon, Georgia, United States, 31201
        • Central Georgia Gynecologic Oncology
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center
      • Savannah, Georgia, United States, 31405
        • St. Joseph's - Candler Gynecologic Oncology
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern University - Robert H. Lurie Comprehensive Cancer Center
      • Hinsdale, Illinois, United States, 60521
        • Sudarshan K. Sharma, MD, LTD
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Gynecologic Oncology
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas Medical Center
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Medical Partners Women's Health
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medical Institution
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital & Medical Center
      • Worcester, Massachusetts, United States, 01605
        • University of Massachusetts Memorial Healthcare
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • St. Joseph Mercy Hospital
      • Battle Creek, Michigan, United States, 49017
        • Bronson Battle Creek
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute - Wayne State University
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health at Butterworth Campus
      • Grand Rapids, Michigan, United States, 49503
        • Saint Mary's Health Care
      • Grand Rapids, Michigan, United States, 49503
        • Grand Rapids Clinical Oncology
      • Grand Rapids, Michigan, United States, 49546
        • Gynecologic Oncology of West Michigan
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Muskegon, Michigan, United States, 49444
        • Mercy Health Partners - Mercy Campus
      • Reed City, Michigan, United States, 49677
        • Reed City Hospital - Spectrum Health
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Minnesota Oncology Coon Rapids Clinic
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Minneapolis, Minnesota, United States, 55404
        • Abbott Northwestern Hospital
      • Saint Louis Park, Minnesota, United States, 55426
        • Park Nicollet Frauenshuh Cancer Center
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro Minnesota Clinical Oncology Program
      • Saint Paul, Minnesota, United States, 55102
        • Minnesota Oncology Hematology - St. Paul Cancer Center
      • Woodbury, Minnesota, United States, 55125
        • Woodbury Clinic - CornerStone Medical Specialty Centre
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
      • Jackson, Mississippi, United States, 32916
        • St. Dominic-Jackson Memorial Hospital
    • Missouri
      • Columbia, Missouri, United States, 65211
        • Ellis Fischel Cancer Center - University of Missouri
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Women's Cancer Care Center of Nevada
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, United States, 87016
        • Southwest Gynecologic Oncology Associates
      • Las Cruces, New Mexico, United States, 88011
        • Memorial Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Women's Cancer Care Associates
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • 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
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10016
        • NYU Langone Medical Center - Cancer Institute
      • Syracuse, New York, United States, 13057
        • Gynecologic Oncology of Central New York - SUNY Upstate
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Hope Women's Cancer Center
      • Burlington, North Carolina, United States, 27215
        • Alamance Regional Cancer Center
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Medical Center / Levine Cancer Institute
      • Concord, North Carolina, United States, 28025
        • Carolinas Medical Center - Northeast
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Science
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health System
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
      • Cleveland, Ohio, United States, 44111
        • Fairview Hospital Moll Pavilion Cancer Center
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
      • Kettering, Ohio, United States, 45429
        • Women's Cancer Center at Kettering Medical Center
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital - Cleveland Clinic
      • Mentor, Ohio, United States, 44060
        • Lake University Seidman Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Peggy and Charles Stephenson Cancer Center
      • Tulsa, Oklahoma, United States, 74146
        • Tulsa Cancer Institute
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital; Hanjani Institute for Gynecologic Oncology
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Medical Center
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • Hillman Cancer Center - University of Pittsburgh
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital (McGlinn Family Regional Cancer Center)
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital of Rhode Island
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, United States, 29601
        • Bon Secours St. Francis Hospital
      • Spartanburg, South Carolina, United States, 29303
        • Gibbs Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute, University of Utah
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Mid Atlantic Pelvic Surgery Associates
      • Richmond, Virginia, United States, 23229
        • Virginia Gynecology Oncology
      • Roanoke, Virginia, United States, 24016
        • Carilion Clinic Gynecological Oncology
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, United States, 98133
        • Northwest Hospital - UW Medicine
      • Seattle, Washington, United States, 98133
        • Women's Cancer Care of Seattle
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Green Bay Oncology at St. Vincent's Hospital
      • Green Bay, Wisconsin, United States, 54301
        • St Vincent Hospital
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology at St. Mary's Hospital
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin-Madison
      • Manitowoc, Wisconsin, United States, 54221
        • Holy Family Memorial Medical Center
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Medical Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College Of Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center Gynecologic Oncology
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Regional Cancer 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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
  2. 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.
  3. Patient must have measurable disease as defined by RECIST 1.1.
  4. 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.

  5. 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.
  6. 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.
  7. 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.
  8. Patients must have a GOG performance status of 0 or 1.
  9. 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.
  10. Patients must meet the entry requirements and undergo the baseline procedures.
  11. Patients must have signed an IRB-approved informed consent form and authorization permitting release of personal health information.

Exclusion Criteria:

  1. Patients who have had treatment with VTX-2337, doxorubicin, PLD, or any other anthracycline.
  2. Patients who have received an investigational agent < 30 days prior to registration.
  3. Patients who have received oral or parenteral corticosteroids < 2 weeks prior to registration or who require ongoing systemic immunosuppressive therapy for any reason.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. Patients with clinically significant cardiovascular disease.
  10. Patients who are pregnant or nursing.
  11. Patients under the age of 18.
  12. Patients with clinical symptoms or signs of gastrointestinal obstruction and/or who require parenteral hydration or nutrition.

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PLD 40 mg/m2 plus VTX-2337
The 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.
Other Names:
  • Doxil
  • Lipodox
TLR8 Agonist
ACTIVE_COMPARATOR: PLD 40 mg/m2 plus placebo
The 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.
Other Names:
  • Doxil
  • Lipodox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Comparison of duration of survival between the 2 treatment groups
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: 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.
Comparison of PFS between the 2 treatment groups
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.
Frequency and Severity of Adverse Events (AEs)
Time Frame: Assessed during each cycle of therapy and within 30 days after the last cycle of therapy
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
Assessed during each cycle of therapy and within 30 days after the last cycle of therapy

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Chair: Bradley J. Monk, MD, St. Joseph's Hospital and Medical Center, Phoenix AZ

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.

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 (ACTUAL)

October 31, 2012

Primary Completion (ACTUAL)

July 31, 2016

Study Completion (ACTUAL)

July 31, 2016

Study Registration Dates

First Submitted

August 10, 2012

First Submitted That Met QC Criteria

August 13, 2012

First Posted (ESTIMATE)

August 16, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

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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