VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
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ClinicalTrials.gov Identifier: NCT01666444 |
Recruitment Status :
Completed
First Posted : August 16, 2012
Results First Posted : September 26, 2019
Last Update Posted : September 26, 2019
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Tracking Information | |||||||
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First Submitted Date ICMJE | August 10, 2012 | ||||||
First Posted Date ICMJE | August 16, 2012 | ||||||
Results First Submitted Date ICMJE | March 5, 2017 | ||||||
Results First Posted Date ICMJE | September 26, 2019 | ||||||
Last Update Posted Date | September 26, 2019 | ||||||
Actual Study Start Date ICMJE | October 31, 2012 | ||||||
Actual Primary Completion Date | July 31, 2016 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE |
Overall survival (OS) of patients treated with VTX-2337 + PLD versus those treated with PLD alone [ Time Frame: Approximately 15 months after the last patient is randomized. ] Overall Survival analysis will occur when 146 deaths have occurred.
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer | ||||||
Official Title ICMJE | 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 | ||||||
Brief 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. 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. |
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Detailed Description | OBJECTIVES Primary Objectives:
Secondary Objectives:
Exploratory Objectives:
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 |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
297 | ||||||
Original Estimated Enrollment ICMJE |
210 | ||||||
Actual Study Completion Date ICMJE | July 31, 2016 | ||||||
Actual Primary Completion Date | July 31, 2016 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01666444 | ||||||
Other Study ID Numbers ICMJE | GOG-3003 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Celgene | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Celgene | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Gynecologic Oncology Group | ||||||
Investigators ICMJE |
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PRS Account | Celgene | ||||||
Verification Date | September 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |