BridgeMD
New treatment option for Ovarian Cancer
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?
INCB123667 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ovarian cancer.
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
- This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.
- 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.
- Have platinum-resistant disease:
- 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...
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.
- Have platinum-resistant disease:
- 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's taking place
- 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 - 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?
Study sites include 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 location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.