Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a microtubule inhibitor indicated for the treatment of: • Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. FDA label
Also known as [14C]-CORT125134, Relacorilant, Abraxane, Nanoparticle albumin-bound paclitaxel, Relacorilant after a high-fat meal, Relacorilant after a low-fat meal
CORT125134 · 13 trials · 19 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
All treatment-emergent adverse events were recorded and summarized.
All treatment-emergent adverse events with Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (severe) were recorded and summarized.
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 | - |
| Group 1: Low-dose Group | EXPERIMENTAL | 100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. There was no washout between treatment periods. Period 3 was followed by a 4-week follow-up period. Per-protocol, Group 1 did not participate in treatment Period 4. |
| Group 2: High-dose Group | EXPERIMENTAL | 250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period. |
| 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. |
| CORT125134 | DRUG | - |
| 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...
CORT125134 is being developed for the treatment of Cushing's Syndrome, an endocrine disorder. It is a small molecule therapeutic candidate from Corcept Therapeutics Incorporated. The drug has completed a Phase 2 clinical trial in participants with Cushing's Syndrome and is currently at the NDA/BLA stage of development.
CORT125134 is being developed by Corcept Therapeutics Incorporated, which trades on the Nasdaq under the ticker symbol CORT. The company is responsible for the clinical development of the drug for Cushing's Syndrome.
CORT125134 is in the NDA/BLA stage, meaning the developer has submitted or is preparing a New Drug Application or Biologics License Application. It has completed a Phase 2 trial. It is an investigational drug and has not been approved by the FDA.
CORT125134 has been studied in one completed clinical trial: NCT02804750, titled "Study to Evaluate CORT125134 in Participants With Cushing's Syndrome." This Phase 2 trial enrolled 35 participants across the United States, Hungary, Italy, Netherlands, and United Kingdom. It was a controlled study in adults aged 18 years and older.