NIPH Clinical Trials Search

Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Ovarian Cancer
Date of first enrollment	31/03/2026
Target sample size	30
Countries of recruitment	To be determined,Japan
Study type	Interventional
Intervention(s)	Experimental: Treatment Group A (TGA) INCB123667 at the protocol-defined dose. Drug: INCB123667 - Oral; tablet Experimental: Treatment Group B (TGB) Investigator's choice of chemotherapy at the protocol-defined dose as defined by the protocol. Drug: Investigator's choice of chemotherapy The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol: Other Names: - paclitaxel - pegylated liposomal doxorubicin (PLD) - gemcitabine - topotecan

Outcome(s)

Primary Outcome

1. Progression-Free Survival (PFS) by BICR [Time Frame: Up to 2 years] 2. Overall Survival (OS) [Time Frame: Up to 2 years]

Secondary Outcome

1. Objective response by BICR [Time Frame: Up to 2 years] 2. Duration of Response (DOR) by BICR [Time Frame: Up to 2 years] 3. Progression-Free Survival (PFS) by investigator [Time Frame: Up to 2 years] 4. Objective response by investigator [Time Frame: Up to 2 years] 5. DOR by investigator [Time Frame: Up to 2 years] 6. Treatment Emergent Adverse Events (TEAEs) [Time Frame: Up to 2 years and 30 days] 7. TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment [Time Frame: Up to 2 years and 30 days] 8. Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit [Time Frame: Up to 2 years] 9. Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 28 (C28) score at each postbaseline visit [Time Frame: Up to 2 years] 10. Change from baseline in EQ-5D-5L score at each postbaseline visit [Time Frame: Up to 2 years]

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Female
Include criteria	1. Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. 2. 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. 3. 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. 4. 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. 5. Should have received prior treatment with bevacizumab unless there was a contraindication for its use. 6. Should have received prior treatment with mirvetuximab soravtansine if the tumor is positive for FR-alpha, unless there is an exception for its use on medical grounds. 7. Measurable disease per RECIST v1.1.
Exclude criteria	1. Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer. 2. Have primary platinum-refractory disease, defined as progression on or within 3 months after the last dose of first line platinum-containing therapy. 3. Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment. 4. Known active CNS metastases and/or carcinomatous meningitis. 5. 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. 6. Clinically significant gastrointestinal abnormalities. Other protocol-defined Inclusion/Exclusion Criteria may apply.