Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab [see Clinical Studies ( 14 )] . FDA label
Also known as Relacorilant once daily, CORT-125134
Relacorilant · 12 trials · 18 indications
PFS was assessed as the time from randomization until the time of first documented progressive disease (PD) or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or an unequivocal progression in a non-target lesion, or the appearance of new lesions.
Overall survival (OS) was assessed as the time from randomization to death by any cause. The data values are Kaplan-Meier estimates.
Blood pressure was measured by 24-hour ABPM. The 24-hour average SBP is reported.
Loss of response with respect to HTN was measured using 6 criteria: 1) an increase in SBP of at least 5 mm Hg, 2) an increase in DBP of at least 5 mm Hg, 3) an increase in SBP and/or DBP of at least 5 mm Hg, 4) use of HTN rescue medication, 5) treatment discontinuation, and 6) missing 24-hour ambulatory blood pressure monitoring (ABPM) measurement at the end of the RW Phase. Blood pressure was measured using ABPM. Use of rescue medication was defined as any increase, modification, or addition of antihypertensive medication due to worsening HTN. Treatment discontinuation reports the number of patients who discontinued study treatment in the RW Phase for any reason.
The percentage of patients with a DLT is used to estimate maximum tolerated dose (MTD), the most intense dose/schedule among those evaluated at which \<33% of patients experience DLT.
To evaluate PFS as the time from enrollment until first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by the Investigator, or death due to any cause, whichever comes first.
To evaluate PFS as the time from enrollment until first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by the Investigator, or death due to any cause, whichever occurs first.
Number of patients with treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 or higher
Evaluate the percentage of patients with a dose-limiting toxicity
The Maximum Tolerated Dose and the development regimen of relacorilant with nab-paclitaxel was determined by the number of participants with dose-limiting toxicities as defined in the protocol.
| Arm | Type | Description |
|---|---|---|
| Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 | EXPERIMENTAL | Patients receive nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle in combination with intermittent relacorilant (150 mg relacorilant once daily on the day before, the day of, and the day after nab-paclitaxel), administered orally under fed conditions. Relacorilant will not be administered on Cycle 1 Day -1. |
| Nab-paclitaxel 100 mg/m^2 | ACTIVE_COMPARATOR | Patients receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. |
| Relacorilant | EXPERIMENTAL | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. |
| Placebo | PLACEBO_COMPARATOR | Patients will receive placebo matched to study drug once daily. |
| Relacorilant (OL Phase) | EXPERIMENTAL | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. |
| Relacorilant (RW Phase) | EXPERIMENTAL | Patients who meet any of the response criteria will advance to the RW Phase of the study and receive the same dose of relacorilant as the last dose administered in the OL Phase. |
| Placebo (RW Phase) | PLACEBO_COMPARATOR | Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug. |
| Relacorilant in Combination with Nab-paclitaxel and Gemcitabine | EXPERIMENTAL | The patient will receive relacorilant administered orally under fed conditions, once daily for 3 consecutive days on the day before (excluding Cycle 1 Day -1), the day of, and the day after nab-paclitaxel and gemcitabine intravenous (IV) infusions. Various dose levels and dosing schedules of relacorilant, nab-paclitaxel, and gemcitabine will be evaluated. On days when relacorilant, nab-paclitaxel, and gemcitabine are administered, relacorilant will be administered first, then nab-paclitaxel, and gemcitabine last. |
| Arm A: Relacorilant in Combination with Nab-paclitaxel and Bevacizumab | EXPERIMENTAL | In Arm A, patients with platinum-resistant ovarian cancer will receive the combination of relacorilant with nab-paclitaxel and bevacizumab. |
| Arm B: Relacorilant in Combination with Nab-Paclitaxel and Bevacizumab | EXPERIMENTAL | In Arm B, patients with platinum-sensitive ovarian cancer who have progressed while receiving treatment with a polymerase inhibitor will receive relacorilant in combination with nab-paclitaxel and bevacizumab. |
| Arm C: Relacorilant in Combination with Nab-Paclitaxel | EXPERIMENTAL | In Arm C, patients with previously-treated advanced, recurrent, or metastatic endometrial cancer will receive relacorilant in combination with nab-paclitaxel. |
| Arm A: Continuous Relacorilant Dosing | EXPERIMENTAL | Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle. |
| Arm B: Intermittent Relacorilant Dosing | EXPERIMENTAL | Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle. |
| Arm C: Nab-paclitaxel Comparator | ACTIVE_COMPARATOR | Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over. |
| relacorilant (CORT125134) | EXPERIMENTAL | - |
| Dose Level | EXPERIMENTAL | Relacorilant will be given at a dose once daily. Enzalutamide will be given at a dose once daily. |
| Dabigatran Etexilate (NIMP) and Relacorilant (IMP) | EXPERIMENTAL | Following an overnight fast, participants will receive 75 mg dabigatran etexilate on Day 1, 400 mg dose of relacorilant QD on Days 3 to 13, and 75 mg dabigatran etexilate on Day 12. On Day 12, dabigatran etexilate will be dosed at approximately the same time as the relacorilant dose. |
| Relacorilant in Combination with Pembrolizumab | EXPERIMENTAL | Participants will be treated on Day -3 to Day 1 (Cohort 1 under fasting conditions) or Day -6 to Day 1 (Cohort 2 under fed conditions) for Cycle 1 only. During the lead-in period, 300 mg relacorilant will be administered daily for 4 -7 days. Patients will receive their first pembrolizumab infusion on Cycle 1 Day 1. The participants will then receive combined treatment from Cycle 1 Day 1 until confirmed PD or unacceptable toxicity. Pembrolizumab will be administered every 6 weeks (on Day 1 of each 42-day cycle) and relacorilant will be administered daily. Optional Cohort 3 will lead-in with 400 mg relacorilant once daily for 7 days and combined treatment of relacorilant and pembrolizumab, depending on PD and toxicity. |
| No Hepatic Impairment | EXPERIMENTAL | Subjects with no hepatic impairment will receive relacorilant 300 mg once daily on Days 1 through 10. |
| Moderate Hepatic Impairment | EXPERIMENTAL | Subjects with moderate hepatic impairment (Child-Pugh Class B) will receive relacorilant 300 mg once daily on Days 1 through 10. |
| Mild Hepatic Impairment | EXPERIMENTAL | Subjects with mild hepatic impairment (Child-Pugh Class A) will receive relacorilant 300 mg once daily on Days 1 through 10. |
| Relacorilant with nab-paclitaxel | EXPERIMENTAL | Participants will be treated with relacorilant in combination with nab-paclitaxel at escalating dose levels in either a Continuous-Dosing Regimen or an Intermittent-Dosing Regimen. |
| Name | Type | Description |
|---|---|---|
| Relacorilant 150 mg | DRUG | Relacorilant is administered as capsules for oral dosing once daily on the day before, the day of, and the day after nab-paclitaxel administration. |
| Nab-paclitaxel 80 mg/m^2 | DRUG | Nab-paclitaxel is administered as intravenous (IV) infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle. |
| Nab-paclitaxel 100 mg/m^2 | DRUG | Nab-paclitaxel is administered as IV infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle. |
| Relacorilant | DRUG | Relacorilant is supplied as blister-packed capsules for oral dosing. Relacorilant 400 mg dose consists of 4 relacorilant 100-mg capsules. Relacorilant 100-mg, 200-mg, and 300-mg doses are each given as a combination of 4 capsules containing relacorilant 100-mg and placebo as per the assigned dose. |
| Placebo | OTHER | Placebo is supplied as blister-packed capsules for oral dosing. Each dose consists of 4 capsules containing placebo. |
| Nab-paclitaxel | DRUG | Nab-paclitaxel will be administered via IV infusion. |
| Gemcitabine | DRUG | Gemcitabine will be administered via IV infusion. |
| Relacorilant 150 mg once daily (QD) | DRUG | Relacorilant is administered under fed conditions as capsules for oral dosing on the day before, the day of, and the day after nab-paclitaxel infusion. |
| Bevacizumab 10 mg/kg | DRUG | Bevacizumab is administered as IV infusion on Days 1 and 15. |
| Enzalutamide | DRUG | Enzalutamide will be taken by mouth at assigned dose. Enzalutamide will be obtained as standard of care prescription (not provided by study). |
| Dabigatran Etexilate | DRUG | Dabigatran will be administered orally as a 75 mg capsule on Day 1 and Day 12. |
| Pembrolizumab | DRUG | Pembrolizumab 400 mg infusion every 6 weeks |
| Relacorilant with nab-paclitaxel | DRUG | Relacorilant is supplied as capsules for oral dosing. Nab-paclitaxel administered as an IV infusion. |
Inclusion Criteria: * Signed and dated Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to study-specific screening procedures. * Confirmed histologic diagnosis of high-grade (Grade 3) serous, epithelial ovarian, primary peritoneal, or fallopian tube carc...
Relacorilant is an investigational small molecule drug developed by Corcept Therapeutics Incorporated. It is being studied in several conditions, including Cushing syndrome, hypercortisolism, adrenocortical carcinoma, ovarian cancer, and pancreatic adenocarcinoma. It is not yet approved and remains in clinical development.
Relacorilant targets NR3C1, the glucocorticoid receptor. It acts as an antagonist at this receptor, meaning it blocks glucocorticoid receptor signaling. This target class is relevant to conditions driven by cortisol activity, such as Cushing syndrome and hypercortisolism, as well as certain cancers studied in combination regimens.
Relacorilant is developed by Corcept Therapeutics Incorporated, which trades under the ticker CORT. Corcept is the sponsor of the clinical trials evaluating the drug across its oncology and endocrine indications.
Relacorilant is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Its clinical program includes Phase 2 studies in pancreatic adenocarcinoma and gynecological cancers, along with completed Phase 1 pharmacokinetic studies.
Relacorilant is being studied in NCT07259317, a Phase 2 trial combining it with nab-paclitaxel and gemcitabine in metastatic pancreatic adenocarcinoma, and NCT06906341, a Phase 2 trial in gynecological cancers including ovarian cancer. Completed studies include NCT06094725 in hepatic impairment and NCT05347979, a drug interaction study with dabigatran etexilate.