Ovarian Cancer study: INCB123667
Official title Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
ClinicalTrials.gov ID: NCT07214779
What this study is testing
What is INCB123667?
INCB123667 is an investigational medicine, 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
- The study aims to find out how well INCB123667 works and how safe it is compared with usual chemotherapy for this type of ovarian cancer.
- Who it's for
- Women with ovarian cancer that no longer responds to platinum drugs and whose tumor shows high levels of cyclin E1.
- What's involved
- Participants will be randomly assigned to receive either INCB123667 or the doctor’s chosen chemotherapy, with regular clinic visits for treatment, blood work, and imaging scans.
- Time commitment
- The trial continues until the cancer progresses, with clinic visits typically every 3–4 weeks for treatment and assessments.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Histological diagnosis of 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 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.
- Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available.
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, defined as progression on or within 3 months after the last dose of first line platinum-containing therapy.
- Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment.
- Known active CNS metastases and/or carcinomatous meningitis.
- Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years before the first dose of...
- Clinically significant gastrointestinal abnormalities. Other protocol-defined Inclusion/Exclusion Criteria may apply.
See the full eligibility criteria
- Histological diagnosis of 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 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.
- Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available. If not available, participant must be willing to undergo a pretreatment tumor biopsy.
- Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent chemotherapy is considered an appropriate next therapeutic option.
- Should have received prior treatment with bevacizumab unless there was a contraindication for its use.
- Should have received prior treatment with mirvetuximab soravtansine if the tumor is positive for FRα, unless there is an exception for its use on medical grounds.
- Measurable disease per RECIST v1.1.
- 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, defined as progression on or within 3 months after the last dose of first line platinum-containing therapy.
- Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment.
- Known active CNS metastases and/or carcinomatous meningitis.
- Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years before the first dose of study treatment.
- Clinically significant gastrointestinal abnormalities. Other protocol-defined Inclusion/Exclusion Criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Los Angeles, California, United States
- Billings, Montana, United States
- Charlotte, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Eugene, Oregon, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Sioux Falls, South Dakota, United States
- Chattanooga, Tennessee, United States
- Abilene, Texas, United States
- Sugar Land, Texas, United States
- Townsville, Queensland, Australia
- Box Hill, Victoria, Australia
- Ghent, Belgium
- Montreal, Quebec, Canada
- Lyon, France
- Akashi-shi, Japan
- Hidaka-shi, Japan
- Kōtoku, Japan
+ 28 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; Los Angeles, California, United States; Billings, Montana, United States; Charlotte, North Carolina, United States; Winston-Salem, North Carolina, United States; Eugene, Oregon, United States and 42 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.