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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Thank you

Trial Information

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


OBJECTIVES

Primary Objective:

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.

Secondary Objectives:

- To compare the progression-free survival (PFS) between the two treatment groups using
Immune-Related Response Evaluation Criteria In Solid Tumors (irRECIST).

- 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.

- To compare the disease control rate (DCR) between the two treatment groups using
irRECIST.

- 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 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 in
primary tumor tissue (e.g. immune score), on 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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival (OS) of patients treated with VTX-2337 + PLD versus those treated with PLD alone

Outcome Description:

Overall Survival analysis will occur when 146 deaths have occurred.

Outcome Time Frame:

Approximately 15 months after the last patient is randomized.

Safety Issue:

No

Principal Investigator

Bradley J. Monk, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Joseph's Hospital and Medical Center, Phoenix AZ

Authority:

United States: Food and Drug Administration

Study ID:

GOG-3003

NCT ID:

NCT01666444

Start Date:

October 2012

Completion Date:

June 2016

Related Keywords:

  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • 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
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Medical University of South CarolinaCharleston, South Carolina  29425-0721
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Fairview Southdale HospitalEdina, Minnesota  55435
Medical College of WisconsinMilwaukee, Wisconsin  53226
St. Joseph's Hospital and Medical CenterPhoenix, Arizona  85001-2071
University Hospitals of ClevelandCleveland, Ohio  44106
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Hartford HospitalHartford, Connecticut  06102-5037
Long Beach Memorial Medical CenterLong Beach, California  90806
SUNY Downstate Medical CenterBrooklyn, New York  11203
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Summa Health SystemAkron, Ohio  44312
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
St. Francis Hospital and Medical CenterHartford, Connecticut  06105
Carle Cancer CenterUrbana, Illinois  61801
Northeast Georgia Medical CenterGainesville, Georgia  30501
Greater Baltimore Medical CenterBaltimore, Maryland  21204
St. Joseph Mercy HospitalPontiac, Michigan  48341-2985
Henry Ford Health SystemDetroit, Michigan  48202
Ohio State University Medical CenterColumbus, Ohio  43210
University of Colorado DenverDenver, Colorado  80262
St. Vincent Gynecologic OncologyIndianapolis, Indiana  46260
Central Georgia Gynecologic OncologyMacon, Georgia  31201
Providence Saint Joseph Medical CenterBurbank, California  91505-4866
Memorial Health University Medical CenterSavannah, Georgia  31404
Gynecologic Oncology of West MichiganGrand Rapids, Michigan  49546
Women's Cancer Care AssociatesAlbany, New York  12208
University of Maryland Medical CenterBaltimore, Maryland  21201-1595
The Hospital of Central ConnecticutNew Britain, Connecticut  06050
McFarland ClinicAmes, Iowa  50010
Upstate Carolina CCOPSpartanburg, South Carolina  29303
Carolinas Medical Center - NortheastConcord, North Carolina  28025
Abbott Northwestern HospitalMinneapolis, Minnesota  55430
University of Wisconsin-MadisonMadison, Wisconsin  53792
Southwest Gynecologic Oncology AssociatesAlbuquerque, New Mexico  87106
Alamance Regional Cancer CenterBurlington, North Carolina  27215
Park Nicollet Frauenshuh Cancer CenterMinneapolis, Minnesota  55416
Peggy and Charles Stephenson Cancer CenterOklahoma City, Oklahoma  73104
Bon Secours St. Francis HospitalGreenville, South Carolina  29601
Tulsa Cancer InstituteTulsa, Oklahoma  74136
Sudarshan K. Sharma, MD, LTDHinsdale, Illinois  60521
Minnesota Oncology Coon Rapids ClinicCoon Rapids, Minnesota  55433
Metro Minnesota Clinical Oncology ProgramSt. Louis Park, Minnesota  55416
Minnesota Oncology St. Paul Cancer CenterSt. Paul, Minnesota  55102
Woodbury Clinic - CornerStone Medical Specialty CentreWoodbury, Minnesota  55125
St. Dominic-Jackson Memorial HospitalJackson, Mississippi  32916
Women's Cancer Care Center of NevadaLas Vegas, Nevada  89169
Cooper Health System / Cooper Cancer InstituteCamden, New Jersey  08103
Carolinas Medical Center / Levine Cancer InstituteCharlotte, North Carolina  28204
Women's Cancer Center at Kettering Medical CenterKettering, Ohio  45429
Lake University Seidman Cancer CenterMentor, Ohio  44060
Abington Memorial Hospital; Hanjani Institute for Gynecologic OncologyAbington, Pennsylvania  19001
Reading Hospital (McGlinn Family Regional Cancer Center)West Reading, Pennsylvania  19611
Mid Atlantic Pelvic Surgery AssociatesAnnandale, Virginia  22003