Ovarian Cancer
Conditions
Keywords
INCB123667
Brief summary
The purpose of this study is to evaluate INCB123667 in Combination With Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Participants With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Overexpressing Cyclin E1.
Interventions
DRUGINCB123667
INCB123667 will be administered at the protocol defined dose.
DRUGBevacizumab
Bevacizumab will be administered at the protocol defined dose.
DRUGPlacebo
Placebo will be administered at the protocol defined dose.
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed, histologically confirmed, FIGO Stage III or IV, high-grade serous, high-grade endometrioid, or clear cell ovarian, fallopian tube, or primary peritoneal cancer. * Underwent debulking surgery prior to randomization (either PDS or IDS). * Completed first-line platinum-based chemotherapy in combination with bevacizumab prior to randomization. * Received a minimum of 6 cycles (and no more than 8 cycles) of platinum-taxane chemotherapy. * Received at least 2 infusions of bevacizumab concurrently with the last 2 to 3 cycles of chemotherapy. * No clinical evidence of disease recurrence (ie, NED following surgery) or progression (ie, CR/PR/SD per RECIST v1.1) on completion of platinum-based chemotherapy. * Tumor overexpresses cyclin E1. * Has a local HRD (positive or negative) or BRCA test result available. Participants with BRCA wild-type must have a local HRD result based on a validated test. * ECOG performance status of 0 or 1.
Exclusion criteria
* Ovarian, fallopian tube, or peritoneal cancer of nonepithelial origin or low-grade ovarian cancer. * Deleterious tumor BRCA mutation per local test. * Eligible for treatment with a PARPi as maintenance therapy. * Known additional malignancy that progressed or requires active treatment, or history of other malignancy within 3 years prior to randomization. * History of any clinically significant or uncontrolled cardiovascular disease within 6 months prior to randomization. * Clinically significant gastrointestinal abnormality. * History of thromboembolism and having been on therapeutic anticoagulation for less than 2 weeks prior to randomization. * Current treatment with any strong CYP3A4/CYP3A5 inhibitor or inducer or treatment with a strong CYP3A4/CYP3A5 inhibitor or inducer within 5 half-lives or 28 days (whichever is shorter) prior to randomization. * Exclusionary Laboratory Values: * Platelets: \< 100 × 109/L * Hemoglobin: \< 9 g/dL or \< 5.6 mmol/L * ANC: \< 1.5 × 109/L * ALT: ≥ 2.5 × ULN or ≥ 5 × ULN for participants with liver metastases * AST: ≥ 2.5 × ULN or ≥ 5 × ULN for participants with liver metastases * Total bilirubin: ≥ 1.5 × ULN * Albumin: \< 2.5 g/dL * Calculated CrCl: \< 45 mL/min * Protein in urine: Urine dipstick for proteinuria ≥ 2+ Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) by BICR | Up to approximately 5 years | Defined as the time from randomization until the first documented disease progression or disease recurrence as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 7 years | Defined as the time from randomization until death due to any cause. |
| Progression-Free Survival (PFS) by investigator | Up to approximately 5 years | Defined as the time from randomization until the first documented disease progression or disease recurrence as assessed by the investigator per RECIST v1.1, or death due to any cause, whichever occurs first. |
| Progression-Free Survival on the First Subsequent Therapy (PFS2) | Up to approximately 7 years | Defined as the time from randomization until radiologic or clinical disease progression on the first subsequent therapy as assessed by the investigator, or death due to any cause, whichever occurs first. |
| Second Progression-Free Survival (PFS) | Up to approximately 7 years | Defined as the time from the start of the first subsequent therapy until radiologic or clinical disease progression as assessed by the investigator. |
| Time to First Subsequent Therapy (TFST) | Up to approximately 7 years | Defined as the time from randomization until the start of the first subsequent therapy, or death due to any cause, whichever occurs first. |
| Time to Second Subsequent Therapy (TSST) | Up to approximately 7 years | Defined as the time from randomization until the start of the second subsequent therapy, or death due to any cause, whichever occurs first. |
| Treatment Emergent Adverse Events (TEAEs) | Up to approximately 13 months | 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 approximately 13 months | TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment. |
| 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 | Up to approximately 5 years | The EORTC QLQ-C30 is a validated, self-administered questionnaire developed to assess the quality of life in patients with cancer. It consists of 30 questions divided into several subscales, including 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and a number of single-item measures that assess additional symptoms such as dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. |
| Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) -Ovarian Cancer 28 (OV28) score at each postbaseline visit | Up to approximately 5 years | The EORTC QLQ-OV28 is a validated, self-administered questionnaire developed as a supplementary module to the core QLQ-C30, specifically designed to assess HRQoL in participants with ovarian cancer. It contains 28 questions across several subscales, including 5 symptom scales (abdominal/gastrointestinal, peripheral neuropathy, hormonal/menopausal, chemotherapy side effects, and attitudes towards disease/treatment), 2 functional scales (body image and sexual functioning), and a number of single-item measures addressing issues such as other abdominal symptoms and hair loss. |
| Change from baseline in EQ-5D-5L score at each postbaseline visit | Up to approximately 5 years | The EQ-5D-5L is a validated, self-reported instrument for assessing HRQoL across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels of severity, ranging from no problems to extreme problems. The questionnaire also includes a visual analog scale for self-rated overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health). |
Contacts
CONTACTIncyte Corporation Call Center (US)
CONTACTIncyte Corporation Call Center (ex-US)
STUDY_DIRECTORIncyte Medical Monitor
Incyte Corporation
Outcome results
None listed