Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Relacorilant · 11 trials · 11 indications
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 assess time from randomization until the date of first documented progressive disease (PD) by RECIST v1.1 (as determined by the Investigator at the local site), 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
Ratio of population geometric means (GMR) of AUC0-tz for Test 1 (relacorilant 3×100-mg softgel capsules) and Reference (relacorilant 6×50-mg hard-shell capsules) and for Test 2 (relacorilant 3×100-mg hard-shell capsules) and Reference (relacorilant 6×50-mg hard-shell capsules)
| Arm | Type | Description |
|---|---|---|
| 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: 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 | - |
| 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. |
| Treatment Sequence 1 | EXPERIMENTAL | Participants will receive relacorilant 400 mg once daily (QD) for 5 days in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
| Treatment Sequence 2 | EXPERIMENTAL | Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
| Treatment Sequence 3 | EXPERIMENTAL | Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
| Treatment Sequence 4 | EXPERIMENTAL | Participants will receive relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
| Treatment Sequence 5 | EXPERIMENTAL | Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
| Treatment Sequence 6 | EXPERIMENTAL | Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
| Treatment Sequence 7 | EXPERIMENTAL | Participants will receive relacorilant 400 mg QD for 5 days in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
| Treatment Sequence 8 | EXPERIMENTAL | Participants will receive placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
| Treatment Sequence 9 | EXPERIMENTAL | Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
| Treatment Sequence 10 | EXPERIMENTAL | Participants will receive relacorilant 400 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
| Treatment Sequence 11 | EXPERIMENTAL | Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
| Treatment Sequence 12 | EXPERIMENTAL | Participants will receive placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
| 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 3x100mg softgel capsules | EXPERIMENTAL | Relacorilant (3x100 mg softgel capsules) |
| Relacorilant 3x100mg hard-shell capsules | EXPERIMENTAL | Relacorilant (3x100 mg hard-shell capsules) |
| Relacorilant 6x50mg hard-shell capsules | EXPERIMENTAL | Relacorilant (6x50mg hard-shell capsules) |
| Part 1 Period 1 | EXPERIMENTAL | Part 1 Period 1: Relacorilant 350mg will be given once on Day 1 |
| Part 1 Period 2 | EXPERIMENTAL | Part 1 Period 2: Itraconazole 200mg will be given for three days |
| Part 1 Period 3 | EXPERIMENTAL | Part 1 Period 3: Relacorilant 350mg will be given once with concomitant itraconazole and itraconazole will continue for three additional days |
| Part 2 Period A | EXPERIMENTAL | Part 2 Period A: Relacorilant 300mg will be given once daily for 10 days |
| Part 2 Period B | EXPERIMENTAL | Part 2 Period B: Relacorilant 300mg will be given once daily in combination with itraconazole 200mg once daily for 10 days |
| Name | Type | Description |
|---|---|---|
| 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. |
| Dabigatran Etexilate | DRUG | Dabigatran will be administered orally as a 75 mg capsule on Day 1 and Day 12. |
| Placebo to relacorilant | DRUG | Placebo to relacorilant capsule by mouth once daily |
| Moxifloxacin | DRUG | Moxifloxacin 400 mg tablet by mouth |
| Pembrolizumab | DRUG | Pembrolizumab 400 mg infusion every 6 weeks |
| Relacorilant (3x100 mg softgel capsules) | DRUG | A single relacorilant 300mg dose (3x100 mg softgel capsules) will be given once on Day 1 of one of three treatment periods. |
| Relacorilant (3x100 mg hard-shell capsules) | DRUG | A single relacorilant 300mg dose (3x100 mg hard-shell capsules) will be given once on Day 1 of one of three treatment periods. |
| Relacorilant (6x50mg hard-shell capsules) | DRUG | A single relacorilant 300mg dose (6x50mg hard-shell capsules) will be given once on Day 1 of one of three treatment periods. |
| Relacorilant 350mg | DRUG | Relacorilant 350mg |
| Itraconazole | DRUG | Itraconazole 200 mg |
| Relacorilant 300mg | DRUG | Relacorilant 300mg |
Inclusion Criteria: * Shows lack of cortisol suppression on dexamethasone suppression test * Suppressed or low early-morning adrenocorticotropic hormone (ACTH) levels * A radiologically confirmed adrenal lesion * Has IGT or DM * Has uncontrolled HTN Exclusion Criteria: * Has severe, uncontrolled ...
Relacorilant is an investigational small molecule being studied for use in Cushing syndrome, solid tumors, recurrent ovarian cancer, adenocarcinoma, and hepatic impairment. It is being developed by Corcept Therapeutics Incorporated (CORT) and is currently in Phase 2 clinical development for these indications.
Relacorilant is a selective glucocorticoid receptor modulator. It works by binding to the glucocorticoid receptor, which is involved in regulating various physiological processes. This mechanism is being studied for its potential effects in oncology and endocrine conditions like Cushing syndrome.
Relacorilant is being developed by Corcept Therapeutics Incorporated, a biopharmaceutical company traded on NASDAQ under the ticker symbol CORT. The company is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications.
Relacorilant is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials, with one active Phase 2 study currently recruiting participants. The drug is investigational and has not been approved by regulatory authorities for any indication.
Relacorilant has been studied in several clinical trials. NCT02762981 evaluated it with nab-paclitaxel in solid tumors, NCT03604198 is an extension study in Cushing syndrome, NCT05347979 assessed its effect on drug interactions, and NCT07259317 is an ongoing Phase 2 trial in metastatic pancreatic adenocarcinoma.
Yes, Relacorilant is also known as CORT125134. The clinical trial NCT02762981, which studied the drug in combination with nab-paclitaxel in solid tumors, explicitly refers to Relacorilant as CORT125134 in its title.