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RecruitingLast updated: 1 December 2023

ROSELLA: This study is evaluating the effectiveness of an investigational drug called relacorilant when given in combination with chemotherapy, compared to chemotherapy alone, in people with advanced, platinum-resistant, high-grade epithelial ovarian, primary peritoneal or fallopian-tube cancer who have had previous treatmentA 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

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two treatment arms.

In Arm 1 (Experimental), participants will receive nab-paclitaxel (chemotherapy) plus relacorilant. Nab-paclitaxel will be given on Days 1, 8 and 15 of each 28-day cycle via intravenous (IV) infusion. Relacorilant will be given intermittently via oral tablet (once daily on the day before, the day of, and the day after nab-paclitaxel).

In Arm 2 (Active Comparator), participants will receive nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle via IV infusion.

Conditions

This trial is treating patients with advanced, platinum-resistant, high-grade serous epithelial ovarian, primary peritoneal or fallopian-tube cancer

Cancer

Female Reproductive System Cancers Gynaecological

Age

People18+

Phase

III

Trial Acronym

ROSELLA

More information

Trial Identifiers

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Trial sponsor

Corcept Therapeutics

Scientific Title

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

Eligibility

Inclusion

  • 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.

Exclusion

  • 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.

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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