A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
- Registration Number
- NCT07023627
- Lead Sponsor
- Incyte Corporation
- Brief Summary
This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 160
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Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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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.
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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.
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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.
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Must have received bevacizumab unless there was a contraindication for its use.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 INCB123667 INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol. Cohort 2 INCB123667 INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol. Cohort 3 INCB123667 INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
- Primary Outcome Measures
Name Time Method Objective Response by IRC Up to 2 years Defined as having a confirmed best overall response of complete response (CR) or partial response (PR), as determined by independent review committee (IRC) assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) by IRC Up to 2 years Defined as the time from the earliest date of CR or PR contributing to a subsequently confirmed CR or PR until the earliest date of disease progression, as determined by IRC assessment per RECIST v1.1, or death due to any cause, whichever occurs first.
Progression-Free Survival (PFS) by IRC Up to 2 years Defined as the time from the date of first dose of study drug until the earliest date of disease progression as determined by IRC assessment per RECIST v1.1, or death due to any cause, whichever occurs first.
Overall Survival (OS) Up to 2 years Defined as the time from the date of first dose of study drug until death due to any cause.
Objective Response by Investigator Up to 2 years Defined as having a confirmed best overall response of CR or PR, as determined by investigator assessment per RECIST v1.1.
DOR by investigator Up to 2 years Defined as the time from the earliest date of CR or PR contributing to a subsequently confirmed CR or PR until the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first.
PFS by Investigator Up to 2 years Defined as the time from the date of first dose of study drug until the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first.
Treatment Emergent Adverse Events (TEAE'S) Up to 2 years and 30 days Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug until 30 days after the last dose of study drug or the start of new anticancer therapy, whichever occurs first.
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment Up to 2 years and 30 days TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment.
Trial Locations
- Locations (73)
Usa Health Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
Uams Winthrop P Rockefeller Cancer Institute
🇺🇸Little Rock, Arkansas, United States
University of California, Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Scripps Healthscripps Mercy Hospital Prebys Cancer Center
🇺🇸San Diego, California, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Northeast Georgia Medical Center Gainesville
🇺🇸Gainesville, Georgia, United States
Parkview Research Center
🇺🇸Fort Wayne, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Community Health Network, Inc.
🇺🇸Indianapolis, Indiana, United States
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