A clinical trial of relacorilant (study drug) with nab-paclitaxel in patients with ovarian, fallopian tube or peritoneal cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Corcept Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

21 Apr 2023 → ongoing

Decision date (initial)

2024-08-05

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Corcept Therapeutics Incorporated, US

External identifiers

EU CT number

2024-514080-25-00

EudraCT number

2022-000662-18

ClinicalTrials.gov

NCT05257408

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacokinetic, Safety, Efficacy, Pharmacodynamic, Others

The primary efficacy objectives of this study are to evaluate progression-free survival (PFS) by BICR and overall survival (OS) in patients treated with an intermittent regimen of relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.

Secondary objectives 1

1. The secondary efficacy objectives are to evaluate patients treated with an intermittent regimen of relacorilant in combination with nab-paclitaxel compared with nab-paclitaxel monotherapy: ▪ To evaluate PFS as assessed by the Investigator or local radiologist ▪ To evaluate objective response rate (ORR) ▪ To evaluate best overall response (BoR) ▪ To evaluate duration of response (DoR) ▪ To evaluate clinical benefit rate (CBR) at 24 weeks ▪ To evaluate response according to cancer antigen 125 (CA-125) using Gynecologic Cancer InterGroup (GCIG) criteria. A combined-response endpoint based on RECIST v1.1 and GCIG criteria will also be reported.

Conditions and MedDRA coding

Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 14

1. Signed and dated Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to study-specific Screening procedures.
2. Able to swallow and retain oral medication and does not have uncontrolled emesis.
3. Received at least 1 but ≤3 lines of prior systemic anticancer therapy (See Protocol for the guidance in counting the number of prior lines of therapy) with documented progressive disease or intolerance to the most recent therapy. At least 1 prior line of platinum therapy is required and prior treatment with bevacizumab is required.
4. Has adequate organ function meeting the protocol-defined laboratory test criteria.
5. Negative pregnancy test for patients of childbearing potential. Patients of childbearing potential must agree to use highly effective contraceptive method(s); hormonal contraceptives are not allowed.
6. COVID-19 approved vaccines (or vaccines with regulatory health authority's emergency use authorization / conditional marketing authorization) are accepted concomitant medications when recommended by the Investigator. Exceptions may apply should the Investigator and the Medical Monitor determine that the vaccine will interfere with the objectives of the study.
7. Female patients aged ≥18 years old at time of consent.
8. Confirmed histologic diagnosis of high-grade (Grade 3) serious, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma (highgrade endometroid epithelial or carcinosarcoma with ≥30% epithelial component are eligible)
9. Patients must have platinum-resistant disease (defined as progression < 6 months (+7 days) from completion of a platinum-containing therapy).
10. Must consent to provide archival tumor-tissue block or slides, if available. Patients may consent to an optional tumor biopsy if archival tumor-tissue is unavailable.
11. Has a life expectancy of ≥3 months.
12. At least one lesion that meets the definition of measurable disease by RECIST v.1.1 (previously irradiated lesions not allowed as measurable disease unless there is documented evidence of progression in the lesions).
13. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
14. Able to comply with protocol requirements.

Exclusion criteria 20

1. Has clinically relevant and reversible toxicity from prior systemic anticancer therapies or radiotherapy that has not resolved to ≤Grade 1 prior to randomization.
2. Has had any major surgery within 4 weeks prior to randomization. If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting the study treatment.
3. Has low-grade serious or endometrioid histology other than epithelial, or clear cell, or mucinous, or sarcomatous with less than 30% epithelial histology component, or mixed tumors containing any of these histologies, or borderline ovarian tumor.
4. Has primary platinum-refractory disease, defined as disease that did not respond to, or has progressed during or within ≤ 1 month from completion of a platinum-containing chemotherapy in first-line treatment (measured from the date of the last dose of platinum).
5. Has not received prior bevacizumab treatment.
6. Has been treated with the following prior to randomization: − Chemotherapy, immunotherapy, investigational agent etc. treatments for disease under study within 5 times of half-life of the prior therapy, or 28 days if 5 times the half-life of the prior therapy is longer than 28 days, before the first dose of study drug. − Radiotherapy not completed at least 2 weeks prior to first dose of study drug. − Hormonal anticancer therapies within 7 days of first dose of study drug. − Systemic, inhaled, or prescription strength topical corticosteroids within a period equivalent to 5 times the half-life of the corticosteroid used prior to first dose of study drug.
7. Has received wide-field radiation to more than 25% of marrowbearing areas.
8. Has toxicities of prior therapies that are reversible and have not resolved the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, ≤Grade 1.
9. Requires treatment with chronic or frequently used oral corticosteroids for medical conditions or illnesses (e.g., rheumatoid arthritis, immunosuppression after organ transplantation).
10. Has a history of severe hypersensitivity or severe reaction to any of the study drugs.
11. Is receiving concurrent treatment with mifepristone or other GR modulators.
12. Has peripheral neuropathy from any cause > Grade 1.
13. Pregnant or lactating patients or patients expecting to conceive children within the projected duration of the trial, starting with the Screening visit through at least 6 months after the last dose of study treatment.
14. Has clinically significant uncontrolled condition(s) which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's safety or participation.
15. Has current active (chronic/acute) infection with Human immunodeficiency virus, or hepatitis C virus or hepatitis B virus.
16. Has any untreated or symptomatic central nervous system (CNS) metastases.
17. Patients with a history of other malignancy within 3 years prior to randomization.
18. Is taking a prohibited concomitant medication listed in protocol (some of the prohibited concomitant medications listed may require a washout period prior to the first dose of study drug).
19. Concurrent treatment on other investigational treatment studies for ovarian, fallopian-tube, or primary peritoneal cancer.
20. Has received a live vaccine within 30 days prior to the study start date.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The dual primary efficacy endpoints include the following: • PFS: Time from randomization until first documented progressive disease (PD) by RECIST v1.1 per BICR, or death due to any cause, whichever occurs first, • ▪ OS: Time from randomization to death by any cause.

Secondary endpoints 3

1. • PFS (Investigators): Time from randomization until PD or death whichever occurred first as assessed by Investigator using RECIST v1.1.
2. • ORR: Proportion of patients with measurable disease at Baseline who attain complete response (CR) or partial response (PR) by RECIST v1.1. • BoR: Recorded from the date of randomization until PD/recurrence (or death). • DoR: Time from the first objective response (CR or PR) to first objectively documented PD or death (whichever occurs first).
3. • CBR at 24 weeks: proportion of patients who attain CR, PR, or stable disease (SD) for 24 weeks as per RECIST v1.1. • CA-125 response will be assessed per GCIG criteria • Combined response according to RECIST v1.1 + GCIG criteria. Responses will be reported separately and combined for RECIST v1.1 and CA-125/GCIG criteria.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Corcept Therapeutics Inc.

Sponsor organisation

Corcept Therapeutics Inc.

Address

101 Redwood Shores Parkway

City

Redwood City

Postcode

94065-1176

Country

United States

Scientific contact point

Organisation

Corcept Therapeutics Inc.

Contact name

Corcept Therapeutics Incorporated

Public contact point

Organisation

Corcept Therapeutics Inc.

Contact name

Corcept Therapeutics Incorporated

Third parties 18

Locations

6 EU/EEA countries · 32 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 58 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications