NCT01666444|CompletedPhase 2ResultsDMC

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

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

Celgene ClinicalTrials.gov

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1 other identifier

GOG-3003

Study Type

interventional

Target

297

Locations

1 country

Sites

136

Timeline

RegisteredAug 2012

StartedOct 2012

CompletionJul 2016

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

297

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2012

Typical duration for phase_2

Geographic Reach

1 country

136 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.8 years study duration

First Submitted

Initial submission to the registry

August 10, 2012

Completed

6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed

3 months until next milestone

Study Start

First participant enrolled

October 31, 2012

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2016

Completed

3.2 years until next milestone

Results Posted

Study results publicly available

September 26, 2019

Completed

Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

3.8 years

First QC Date

August 10, 2012

Results QC Date

March 5, 2017

Last Update Submit

September 24, 2019

Conditions

Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer

Keywords

recurrent epithelial ovarian cancerrecurrent fallopian tube cancerrecurrent primary peritoneal cavity cancerovarian serous cystadenocarcinomaovarian endometrioid adenocarcinomaovarian mucinous cystadenocarcinomaovarian undifferentiated adenocarcinomaovarian clear cell cystadenocarcinomaovarian mixed epithelial carcinomaBrenner tumor

Outcome Measures

Primary Outcomes (1)

Overall Survival
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 Outcomes (2)

Progression-free Survival (PFS)
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)
Assessed during each cycle of therapy and within 30 days after the last cycle of therapy

Study Arms (2)

PLD 40 mg/m2 plus VTX-2337

EXPERIMENTAL

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.

Drug: pegylated liposomal doxorubicin (PLD)Drug: VTX-2337

PLD 40 mg/m2 plus placebo

ACTIVE COMPARATOR

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.

Drug: pegylated liposomal doxorubicin (PLD)Drug: Placebo

Interventions

pegylated liposomal doxorubicin (PLD)DRUG

Also known as: Doxil, Lipodox

PLD 40 mg/m2 plus VTX-2337PLD 40 mg/m2 plus placebo

VTX-2337DRUG

TLR8 Agonist

PLD 40 mg/m2 plus VTX-2337

PlaceboDRUG

PLD 40 mg/m2 plus placebo

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.
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.
+5 more criteria

You may not qualify if:

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.
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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Celgenelead
Gynecologic Oncology Groupcollaborator

Study Sites (136)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Winthrop P. Rockefeller Cancer Institute - University of Arkansas

Little Rock, Arkansas, 72205, United States

Location

Providence Saint Joseph Medical Center

Burbank, California, 91505, United States

Location