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Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers

ConditionsOvarian CancerFallopian Tube CancerPeritoneal NeoplasmsEndometrial Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCorcept Therapeutics

About this trial

This is a Phase 2, open-label, global, multi-arm study to evaluate efficacy and safety of relacorilant in combination with other treatments in patients with gynecological cancers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologic diagnosis of epithelial ovarian, primary peritoneal, or fallopian-tube carcinoma

Arm A Only: Platinum-resistant disease

Arm B Only: Platinum-sensitive disease who had progression while receiving treatment with a poly(ADP-ribose) polymerase (PARP) inhibitor

Life expectancy of ≥3 months

Disqualifiers

Arm A Only: Has progressed while receiving weekly paclitaxel or nab-paclitaxel

Prior enrollment in a clinical trial of relacorilant

Prior anticancer therapy related toxicities not resolved to grade ≤1

Any surgery within 4 weeks prior to enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Nab-paclitaxel 80 mg/m^2

    Drug

    Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.

  • Bevacizumab 10 mg/kg

    Drug

    Bevacizumab is administered as IV infusion on Days 1 and 15.

Treatment groups

270 Participants
are divided into 3 treatment groups
Group A: Arm A: Relacorilant in Combination with Nab-paclitaxel and BevacizumabExperimental treatment 3 interventions
Group B: Arm B: Relacorilant in Combination with Nab-Paclitaxel and BevacizumabExperimental treatment 3 interventions
Group C: Arm C: Relacorilant in Combination with Nab-PaclitaxelExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

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.

Time frame
Date of first dose until PD or death, up to 18 months

Secondary outcomes

1

Objective Response Rate (ORR)

To evaluate the proportion of patients with measurable disease at Baseline who attain complete response (CR) or partial response (PR) by RECIST version 1.1.

Time frame
Date of first dose until PD or death, up to 18 months
2

Best Overall Response Rate (BOR)

To evaluate the BOR by RECIST version 1.1 recorded from the date of enrollment until PD or death.

Time frame
Date of first dose until PD or death, up to 18 months
3

Duration of Response (DOR)

To evaluate DOR as the time from the first CR or PR to first objectively documented PD or death, whichever comes first.

Time frame
Time of first objective response until PD or death, up to 18 months
4

Clinical Benefit Rate (CBR)

To evaluate CBR as the proportion of patients who attain CR, PR, or stable disease (SD) at Week 24 as per RECIST version 1.1.

Time frame
Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Corcept Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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