Predictive Biomarkers for IGF1R Targeted Therapy in Ovarian Cancer
1 other identifier
observational
20
1 country
1
Brief Summary
The main goal of this study is to employ a novel proteomic approach to identify predictive tumor biomarkers that will increase the efficacy of insulin-like growth factor (IGF1R) targeted therapy in epithelial ovarian cancer. It is expected that these predictive biomarkers will be applied to increase the response rate in selected groups of patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2016
CompletedFirst Posted
Study publicly available on registry
March 17, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedMarch 17, 2016
March 1, 2016
3 years
March 13, 2016
March 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Responsive to IGF1R therapy
Mean tumor volume will be calculated and growth inhibition will be reported as the percentage decrease of tumor volume compared with the control.
One year
Secondary Outcomes (1)
Proteomic Signature of IGF1R Responsive Tumors
One year
Study Arms (2)
MK-0646
Tumor specimens removed from 20 women with ovarian cancer are injected into 40 mice treated with the IGF1R antibody MK-0646. The drug will be administered twice weekly, via IP injection at a dose of 500 microgram per animal.
Control
Tumor specimens removed from 20 women with ovarian cancer are injected into 40 mice who receive no other treatment.
Interventions
Eligibility Criteria
Twenty fresh ovarian cancer specimens will be obtained from patients operated on and treated at the Hillel Yaffe Medical Center.
You may qualify if:
- Patients with ovarian cancer
You may not qualify if:
- All others
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hillel Yaffe Medical Center
Hadera, 38100, Israel
Biospecimen
Tumors that will be removed from women operated on for ovarian cancer.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilan Bruchim, MD
Hillel Yaffe Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2016
First Posted
March 17, 2016
Study Start
May 1, 2016
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
March 17, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share