ROSELLA - A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel Versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

Studio Clinico

Patologia: Tumori dell’ovaio

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Prima linea, Seconda linea, Terza/N linea

Criteri di inclusione: 

- 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 carcinoma.
- Patients must have platinum-resistant disease (defined as RECIST v1.1 defined progression <6 months from completion of a platinum-containing therapy).
- Must consent to provide archival tumor-tissue block or slides. Patients may consent to an optional tumor biopsy if archival tumor is unavailable.
- Has a life expectancy of ≥3 months.
- At least one lesion that meets the definition of measurable disease by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Able to comply with protocol requirements.
- Able to swallow and retain oral medication and does not have uncontrolled emesis.
- Received at least 1 but ≤3 lines of prior systemic anticancer therapy and at least 1 prior line of platinum therapy and prior treatment with bevacizumab is required.
- Has adequate organ function meeting the following laboratory-test criteria: Absolute neutrophil count (ANC) ≥1500 cells/mm^3, Platelet count ≥100,000/mm^3, Hemoglobin ≥9 g/dL, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN), or ≤5 × ULN in context of liver metastases, Total bilirubin ≤1.5 × ULN, and Albumin ≥3 g/dL, and creatinine clearance >40 mL/min/1.73 m^2 (measured or estimated).
- 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.
- Coronavirus disease (COVID-19) approved vaccines are accepted concomitant medications when recommended by the Investigator.

Criteri di esclusione: 

- Has clinically relevant toxicity from prior systemic anticancer therapies or radiotherapy that has not resolved to ≤Grade 1 prior to randomization.
- Has had any major surgery within 4 weeks prior to randomization.
Has low-grade endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing any of these histologies, or low-grade or borderline ovarian tumor.
- Has primary platinum-refractory disease, defined as disease that did not respond to or has progressed ≤1 month of the last dose of first-line platinum-containing chemotherapy.
- Has not received prior bevacizumab treatment.
- Has been treated with the following prior to randomization: chemotherapy, immunotherapy, investigational agent treatments for disease under study within 28 days before 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, and systemic, inhaled, or prescription strength topical corticosteroids within 21 days of first dose of study drug.
- Has received wide-field radiation to more than 25% of marrow-bearing areas.
- Has toxicities of prior therapies that have not resolved the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, ≤Grade 1.
- Requires treatment with chronic or frequently used oral corticosteroids for medical conditions or illnesses.
- Has a history of severe hypersensitivity or severe reaction to any of the study drugs.
- Is receiving concurrent treatment with mifepristone or other glucocorticoid receptor (GR) modulators.
- Has peripheral neuropathy from any cause >Grade 1.
- 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 1 month after the last dose of relacorilant, or 6 months after the last dose of nab-paclitaxel whichever is the longest.
- Has clinically significant uncontrolled condition(s) or condition which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's safety or participation.
- Has current chronic/active infection with human immunodeficiency virus or current chronic/active infection with hepatitis C virus or hepatitis B virus.
- Has any untreated or symptomatic central nervous system (CNS) metastases.
- Patients with a history of other malignancy within 3 years prior to randomization
- Is taking a concomitant medication that is a strong cytochrome P450 (CYP)3A inhibitor or strong CYP3A inducer, or that is a substrate of CYP3A with a narrow therapeutic window.
- Concurrent treatment on other investigational treatment studies for the treatment of ovarian, fallopian tube, or primary peritoneal cancer.
- Has received a live vaccine within 30 days of prior to the study start date.

Trattamento sperimentale: 

Nab-paclitaxel 80 mg/m^2 with Relacorilant 150 mg

Trattamento di controllo: 

Nab-paclitaxel 100 mg/m^2

Obiettivi primari dello studio: 

The primary objective of this study is to evaluate progression-free survival (PFS) by blinded independent central review (BICR) in patients treated with intermittent regimen of relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2022-000662-18 - NCT05257408

Data di inserimento: 09.06.2023

Data di aggiornamento: 25.01.2024

Promotore

Corcept Therapeutics

Principal Investigator ITALIA

Policlinico Universitario Fondazione Agostino Gemelli, Roma

Riferimento: Prof.ssa Domenica Lorusso

Telefono: 0630158545

Email: domenica.lorusso@policlinicogemelli.it

Localita: Roma