Phase 2 Study of JX-594 in Patients With Peritoneal Carcinomatosis of Ovarian Cancer Origin
NCT02017678 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2014-09-17
Summary
This is a single-arm open-label Phase 2 study in patients with peritoneal carcinomatosis of ovarian origin that are not eligible for curative treatments. Patients will receive 5 weekly IV infusions of JX-594 until radiographically determined progressive disease. Patients will be allotted in a 1:1 ratio to undergo a laparoscopy and tumor biopsy 10 days after dose 1 or 10 days after Dose 5. Patients will be monitored on study until evidence of progression or death or for 12 months post treatment.
Conditions
Interventions
- BIOLOGICAL
-
JX-594
5 weekly IV infusions of JX-594 followed by laparoscopy and biopsy on day 10 or 38.
Sponsors & Collaborators
-
Ontario Institute for Cancer Research
collaborator OTHER -
Andrea McCart
lead OTHER
Principal Investigators
-
Judith Andrea McCart, MD · MOUNT SINAI HOSPITAL
-
Helen MacKay, MD · Princess Margaret Cancer Centre
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2015-01-31
- Completion
- 2015-06-30
Countries
- Canada
Study Locations
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