Ovarian CancerNCT02711865
Predictive Biomarkers for IGF1R Targeted Therapy in Ovarian Cancer
An observational study of Ovarian Cancer, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- IGF1R antibody MK0646 and Saline solution
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- May 2016to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Twenty fresh ovarian cancer specimens will be obtained from patients operated on and treated at the Hillel Yaffe Medical Center.
Who may be able to join
- Patients with ovarian cancer
Who cannot join
- All others
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Rinat Lift, MSc, rinatl@hy.health.gov.il
About this study
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.
- Conditions
- Ovarian Cancer
- Being tested
- IGF1R antibody MK0646, Saline solution
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGF1R antibody MK0646Biological
Saline solutionOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: IGF1R antibody MK0646 | |
| Control | Tumor specimens removed from 20 women with ovarian cancer are injected into 40 mice who receive no other treatment. Receives: Other: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (1)
Proteomic Signature of IGF1R Responsive Tumors
Mass Spectrometry will be used to compare IGF1R responsive and non-responsive tumors to identify the proteins associated with sensitivity to IGF1R therapy.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ilan Bruchim, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711865
- Sponsor's protocol ID
- HYMC-54-15
- Status last verified
- Mar 2016
- First submitted
- 13 Mar 2016
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Biomarkers for IGF1R Targeted Therapy in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02711865
- Acronym / sponsor ID
- HYMC-54-15
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- May 2016
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-0646 | – | Biological: IGF1R antibody MK0646Tumor 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 | – | Other: Saline solutionTumor specimens removed from 20 women with ovarian cancer are injected into 40 mice who receive no other treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty fresh ovarian cancer specimens will be obtained from patients operated on and treated at the Hillel Yaffe Medical Center.
Key inclusion criteria (1 listed)
- Patients with ovarian cancer
Key exclusion criteria (1 listed)
- All others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGF1R antibody MK0646 | Biological | MK-0646 |
| Saline solution | Other | Control |
Primary outcome
Responsive to IGF1R therapy
Time frame: One year
Mean tumor volume will be calculated and growth inhibition will be reported as the percentage decrease of tumor volume compared with the control.
1 secondary outcome
Proteomic Signature of IGF1R Responsive Tumors
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilan Bruchim, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rinat Lift, MSc (972-4-6304335, rinatl@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responsive to IGF1R therapy (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.