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

Phase 1

• Conditions: Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer; MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10061344Term: Peritoneal neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-000662-18-HU
• Lead Sponsor: Corcept Therapeutics Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-14
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 360

Inclusion Criteria

1. Signed and dated Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to study-specific Screening procedures.

2. Female patients aged =18 years old at time of consent.

3. Confirmed histologic diagnosis of high-grade (Grade 3) serous, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma (high-grade endometroid epithelial or carcinosarcoma with =30% epithelial tumor component are eligible).

4. Patients must have platinum-resistant disease (defined as progression <6 months (+7 days) from completion of a platinum-containing therapy).

5. 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.

6. Has a life expectancy of =3 months.

7. 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).

8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

9. Able to comply with protocol requirements.

10. Able to swallow and retain oral medication and does not have uncontrolled emesis.

11. 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.

12. Has adequate organ function meeting the protocol-defined laboratory-test criteria.

13. 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.

14. 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.

Please refer to the protocol for complete list of inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

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 marrow-bearing 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 glucocorticoid receptor (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 the treatment of ovarian, fallopian tube, or primary peritoneal cancer.

20. Has received a live vaccine within 30 days prior to the study start date.

Please refer

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified