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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The purpose of this study is to test whether isoquercetin can reduce markers in the blood that may indicate the risk of blood clots in people with ovarian cancer. The effects of isoquercetin will be compared with those of a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Placebo | Placebo Comparator |
| |
| Cohort B: Isoquercetin daily | Experimental |
| |
| Cohort C: Isoquercetin twice daily | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isoquercetin | Drug | Cohort B and Cohort C will take isoquercetin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of PDI-sensitive, platelet-dependent thrombin generation measured as compared to baseline | The primary endpoint is the maximal inhibition of PDI-sensitive, platelet-dependent thrombin generation measured at either 3 or 6 weeks (relative to baseline). | up to 6 weeks from baseline |
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Inclusion Criteria:
Participants must have histological- or cytological-confirmed ovarian cancer (epithelial, serous, or clear cell) and be receiving first-line chemotherapy (day 1 of isoquercetin should align with day 1 of cycle 1 or 2 of chemotherapy) for neoadjuvant, adjuvant, or advanced settings.
Minimum age 18 years
Life expectancy of greater than 6 months.
ECOG performance status <2
Participants must have preserved organ and marrow function as defined below:
The effects of isoquercetin on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Zwicker, MD | Contact | 646-608-3723 | zwickerj@mskcc.org | |
| Elizabeth Jewell, MD | Contact | 212-639-3366 | jewelle@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Zwicker, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center (Data Collection Only) | Not yet recruiting | Boston | Massachusetts | 02215 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C016527 | isoquercitrin |
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| Placebo | Other | Placebo |
|
| Memorial Sloan Kettering Basking Ridge (All Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
|
| Memorial Sloan Kettering Monmouth (All Protocol Activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (All Protocol Activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities ) | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering Westchester (All Protocol Activities) | Recruiting | Harrison | New York | 10604 | United States |
|
| Memorial Sloan Kettering Cancer Center (All Protocol Activites) | Recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering Nassau (All protocol activities) | Recruiting | Rockville Centre | New York | 11553 | United States |
|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |