TriangleNCT05257408 · CITED IN SOURCE DOCUMENTS
Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2025-04-16
The primary objectives of this study are to evaluate progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS) (evaluated independently, as dual primary endpoints) in patients treated with intermittent regimen of Relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * 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 Criteria: * 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients receive nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle in combination with intermittent relacorilant (150 mg relacorilant once daily on the day before, the day of, and the day after nab-paclitaxel), administered orally under fed conditions. Relacorilant will not be administered on Cycle 1 Day -1.
- intervention Names
- Drug: Nab-paclitaxel 80 mg/m^2
- Drug: Relacorilant 150 mg once daily (QD)
- label
- Nab-paclitaxel 80 mg/m^2 with Relacorilant 150 mg
- type
- EXPERIMENTAL
- description
- Patients receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle.
- intervention Names
- Drug: Nab-paclitaxel 100 mg/m^2
- label
- Nab-paclitaxel 100 mg/m^2
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Nab-paclitaxel 80 mg/m^2 with Relacorilant 150 mg
- description
- Nab-paclitaxel is administered as intravenous (IV) infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle.
- name
- Nab-paclitaxel 80 mg/m^2
- type
- DRUG
- arm Group Labels
- Nab-paclitaxel 80 mg/m^2 with Relacorilant 150 mg
- description
- Relacorilant is administered as capsules for oral dosing.
- name
- Relacorilant 150 mg once daily (QD)
- type
- DRUG
- arm Group Labels
- Nab-paclitaxel 100 mg/m^2
- description
- Nab-paclitaxel is administered as IV infusion on Day 1, 8, and 15 of each 28-day cycle.
- name
- Nab-paclitaxel 100 mg/m^2
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 381
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Time from randomization until the time of first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause, whichever occurs first
- measure
- Progression-free Survival as Assessed by BICR
- time Frame
- Up to 24 months from enrollment of the last patient
- description
- Time from randomization to death by any cause
- measure
- Overall survival
- time Frame
- Up to 24 months from enrollment of the last patient
- secondary Outcomes
- description
- Time from randomization until the time of first documented progressive disease (PD) by RECIST v1.1, or death due to any cause, whichever occurs first
- measure
- PFS as Assessed by the Investigator
- time Frame
- Up to 24 months from enrollment of the last patient
- description
- Proportion of patients with measurable disease at baseline who attain CR or PR by RECIST v1.1.
- measure
- Objective Response as Assessed by BICR
- time Frame
- Up to 24 months from enrollment of the last patient
- description
- Proportion of patients with measurable disease at baseline who attain CR or PR as best response by RECIST v1.1.
- measure
- Best Overall Response as Assessed by BICR
- time Frame
- Up to 24 months from enrollment of the last patient
- description
- Time from when response (CR or PR per RECIST v1.1) is first documented to first objectively documented PD or death (whichever occurs first)
- measure
- Duration of Response as Assessed by BICR
- time Frame
- Up to 24 months from enrollment of the last patient
- description
- Proportion of patients who attain CR, PR, or stable disease (SD) per RECIST v1.1.
- measure
- Clinical benefit rate as assessed by BICR
- time Frame
- 24 weeks
- description
- Cancer antigen (CA)-125 response will be assessed per Gynecologic Cancer Intergroup (GCIG) criteria defined as ≥50% reduction in CA-125 from a pre-treatment sample and maintained for ≥28 days in patients with a pretreatment sample that is at least twice the upper limit of the reference range within 2 weeks before starting the treatment. In addition, patients who have a CA-125 response and whose CA-125 level falls to within the reference range will be classified as CA-125 complete responders.
- measure
- Cancer Antigen (CA)-125 Response
- time Frame
- Up to 24 months from enrollment of the last patient
- description
- Combined response will be assessed for PD per RECIST v1.1 and for CA-125 response per GCIG criteria
- measure
- Combined Response According to RECIST v1.1 and GCIG Criteria
- time Frame
- Up to 24 months from enrollment of the last patient
Full study description
- brief Summary
- The primary objectives of this study are to evaluate progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS) (evaluated independently, as dual primary endpoints) in patients treated with intermittent regimen of Relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.
- detailed Description
- As there are no currently approved therapies or effective standard of care for heavily pretreated patients with ovarian cancer who have exhausted single-agent chemotherapy and/or bevacizumab, the combination of intermittently administered relacorilant and nab-paclitaxel may demonstrate a substantial improvement without increased toxicity compared with nab-paclitaxel. Patients will receive study treatment until confirmed progressive disease (PD) or unacceptable toxicity. All patients will be followed for the collection of study endpoints, inclusive of disease progression and survival.
Source references
- references
- citation
- Lorusso D, Gladieff L, O'Malley DM, Kim JW, Garbaos G, Fagotti A, Gilbert L, Mileshkin L, Quesada S, Hopp E, Lee YJ, Oaknin A, Scaranti M, Kim BG, Clamp A, Prillaman C, Diakos C, Bagameri A, Leiser AL, Salutari V, Monk BJ, Follana P, McClung E, Carbone V, Slomovitz B, Giudice E, Cannizzaro MC, Gavoille L, Devaux A, Scollo P, Scandurra G, Cassani C, Artioli G, Van Gorp T, Santaballa A, Dreiling LK, Kesner-Hays A, Tudor IC, Jubb AM, Colombo N, Olawaiye AB. Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial. Lancet. 2026 Apr 18;407(10538):1513-1524. doi: 10.1016/S0140-6736(26)00462-9. Epub 2026 Apr 10.
- pmid
- 41974149
- type
- DERIVED
- citation
- Olawaiye AB, Gladieff L, O'Malley DM, Kim JW, Garbaos G, Salutari V, Gilbert L, Mileshkin L, Devaux A, Hopp E, Lee YJ, Oaknin A, Scaranti M, Kim BG, Colombo N, McCollum ME, Diakos C, Clamp A, Leiser AL, Balazs B, Monk BJ, Scandurra G, McClung E, Kaczmarek E, Slomovitz B, De La Cueva H, de Carvalho Calabrich AF, Cassani C, You B, Van Gorp T, Churruca C, Caruso G, Nicum S, Bagameri A, Artioli G, Bodnar L, Kang S, Vergote I, Kesner-Hays A, Pashova HI, Pai SG, Tudor IC, Jubb AM, Lorusso D. Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial. Lancet. 2025 Jun 21;405(10496):2205-2216. doi: 10.1016/S0140-6736(25)01040-2. Epub 2025 Jun 2.
- pmid
- 40473448
- type
- DERIVED
- citation
- Olawaiye AB, Kim JW, Bagameri A, Bishop E, Chudecka-Glaz A, Devaux A, Gladieff L, Gordinier ME, Korach J, McCollum ME, Mileshkin L, Monk BJ, Nicum S, Nogueira-Rodrigues A, Oaknin A, O'Malley DM, Orlando M, Dreiling L, Tudor IC, Lorusso D. Clinical Trial Protocol for ROSELLA: a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in advanced platinum-resistant ovarian cancer. J Gynecol Oncol. 2024 Jul;35(4):e111. doi: 10.3802/jgo.2024.35.e111.
- pmid
- 39032926
- type
- DERIVED
- citation
- Colombo N, Van Gorp T, Matulonis UA, Oaknin A, Grisham RN, Fleming GF, Olawaiye AB, Nguyen DD, Greenstein AE, Custodio JM, Pashova HI, Tudor IC, Lorusso D. Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study. J Clin Oncol. 2023 Oct 20;41(30):4779-4789. doi: 10.1200/JCO.22.02624. Epub 2023 Jun 26.
- pmid
- 37364223
- type
- DERIVED
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- 14 CLINICAL STUDIES The efficacy of LIFYORLI in combination with nab-paclitaxel was evaluated in ROSELLA (NCT05257408), a multicenter, open-label, active-controlled, randomized, two-arm, trial in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary p
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Preserved source evidence · Not medical advice