Ovarian Cancer study: INCB123667
Official title A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
ClinicalTrials.gov ID: NCT07023627
What this study is testing
What is INCB123667?
an investigational oral medicine being studied as a potential treatment for platinum‑resistant ovarian cancer with cyclin E1 overexpression
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether INCB123667 is safe and works to treat this type of ovarian cancer.
- Who it's for
- Adults whose ovarian cancer no longer responds to platinum chemotherapy and whose tumor shows high cyclin E1 levels.
- What's involved
- Participants will receive the investigational drug INCB123667 and undergo regular check‑ups and tests to monitor safety and tumor response.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99, women only
You may be able to join if
- Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of a platinum-containing regimen.
- Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum.
- Willingness to undergo a pretreatment biopsy. Note: Tissue from a fresh pretreatment biopsy is preferred, however an archival sample is acceptable as...
- Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent therapy is...
You likely can't join if
- Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian...
- Have primary platinum-refractory disease: either did not respond (CR or PR) to first-line platinum-containing therapy or progressed on or within 3...
- The tumor tests positive for FRα but the participant has not received mirvetuximab soravtansine for any reason other than medical contraindication.
- Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study drug.
- Known active CNS metastases and/or carcinomatous meningitis.
- Known additional malignancy that is progressing or requires active treatment. Other protocol-defined Inclusion/Exclusion Criteria may apply.
See the full eligibility criteria
- Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of a platinum-containing regimen.
- Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum.
- Willingness to undergo a pretreatment biopsy. Note: Tissue from a fresh pretreatment biopsy is preferred, however an archival sample is acceptable as long as the sample is no older than 5 years.
- Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent therapy is considered an appropriate next therapeutic option.
- Must have received bevacizumab unless there was a contraindication for its use.
- If the tumor tests positive for FRα, participants must have received mirvetuximab soravtansine unless there is an exception for its use on medical grounds.
- Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer.
- Have primary platinum-refractory disease: either did not respond (CR or PR) to first-line platinum-containing therapy or progressed on or within 3 months after the last dose of the first line platinum-containing therapy.
- The tumor tests positive for FRα but the participant has not received mirvetuximab soravtansine for any reason other than medical contraindication.
- Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study drug.
- Known active CNS metastases and/or carcinomatous meningitis.
- Known additional malignancy that is progressing or requires active treatment. Other protocol-defined Inclusion/Exclusion Criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Mobile, Alabama, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Washington D.C., District of Columbia, United States
- Fort Myers, Florida, United States
- Miami, Florida, United States
- Miami Beach, Florida, United States
- West Palm Beach, Florida, United States
- Gainesville, Georgia, United States
- Fort Wayne, Indiana, United States
- Iowa City, Iowa, United States
- Louisville, Kentucky, United States
- Shreveport, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Jackson, Mississippi, United States
- St Louis, Missouri, United States
+ 47 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Mobile, Alabama, United States; Los Angeles, California, United States; San Diego, California, United States; Washington D.C., District of Columbia, United States; Fort Myers, Florida, United States; Miami, Florida, United States and 61 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.