Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05257408
Other study ID # CORT125134-556
Secondary ID ROSELLA Study 55
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date June 29, 2022
Est. completion date June 2025

Study information

Verified date April 2024
Source Corcept Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 360
Est. completion date June 2025
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Nab-paclitaxel 80 mg/m^2
Nab-paclitaxel is administered as intravenous (IV) infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant 150 mg once daily (QD)
Relacorilant is administered as capsules for oral dosing.
Nab-paclitaxel 100 mg/m^2
Nab-paclitaxel is administered as IV infusion on Day 1, 8, and 15 of each 28-day cycle.

Locations

Country Name City State
Argentina Site 393 Caba Buenos Aires
Argentina Site 381 Ciudad Autonoma de Buenos Aire Buenos Aires
Argentina Site 395 Ciudad de Cordoba Cordoba
Argentina Site 401 Ciudad de Cordoba Cordoba
Argentina Site 415 Ciudad de Cordoba Cordoba
Argentina Site 404 Ciudad de Mendoza Mendoza
Argentina Site 391 Rosario Santa Fe
Argentina Site 412 Rosario Santa Fe
Australia Site 417 Benowa Queensland
Australia Site 414 Melbourne Victoria
Australia Site 419 Melbourne Victoria
Australia Site 426 St. Leonards New South Wales
Belgium Site 328 Aalst
Belgium Site 109 Brussels
Belgium Site 326 Charleroi
Belgium Site 325 Hasselt
Belgium Site 108 Leuven
Belgium Site 327 Liège
Brazil Site 383 Belo Horizonte Minas Gerais
Brazil Site 424 Brasília Brasília - DF
Brazil Site 382 Fortaleza Ceara
Brazil Site 390 Natal Rio Grande Do Norte
Brazil Site 421 Porto Alegre
Brazil Site 380 Rio De Janeiro
Brazil Site 384 Salvador Bahia
Brazil Site 001 São Paulo
Brazil Site 374 São Paulo
Brazil Site 376 São Paulo
Brazil Site 389 São Paulo
Brazil Site 413 São Paulo
Brazil Site 413 São Paulo SP
Canada Site 273 Montréal Quebec
Canada Site 117 Toronto Ontario
France Site 306 Lille
France Site 347 Montpellier
France Site 307 Nancy
France Site 310 Nice
France Site 289 Paris
France Site 323 Plérin
Hungary Site 322 Budapest
Hungary Site 290 Debrecen
Hungary Site 348 Gyor
Israel Site 309 Haifa
Israel Site 080 Jerusalem
Israel Site 203 Tel Aviv
Italy Site 321 Catania
Italy Site 320 Legnago
Italy Site 122 Milano
Italy Site 295 Pavia
Italy Site 161 Roma
Italy Site 124 Rome
Italy Site 293 Torino
Italy Site 319 Treviso
Korea, Republic of Site 397 Gyeonggi-do
Korea, Republic of Site 396 Seoul
Korea, Republic of Site 398 Seoul
Korea, Republic of Site 399 Seoul
Korea, Republic of Site 400 Seoul
Korea, Republic of Site 402 Seoul
Korea, Republic of Site 403 Seoul
Korea, Republic of Site 409 Seoul
Poland Site 341 Gdynia
Poland Site 331 Poznan
Poland Site 329 Siedlce
Spain Site 349 Badalona
Spain Site 311 San Sebastián
Spain Site 330 Valencia
United Kingdom Site 367 Brighton East Sussex
United Kingdom Site 366 Cheltenham
United Kingdom Site 055 London
United Kingdom Site 344 Manchester
United Kingdom Site 345 Northwood
United Kingdom Site 351 Taunton Somerset
United States Site 292 Albuquerque New Mexico
United States Site 009 Atlanta Georgia
United States Site 272 Atlanta Georgia
United States Site 032 Aurora Colorado
United States Site 229 Austin Texas
United States Site 312 Bedford Texas
United States Site 337 Bethlehem Pennsylvania
United States Site 128 Boston Massachusetts
United States Site 298 Cincinnati Ohio
United States Site 304 Cincinnati Ohio
United States Site 315 Evanston Illinois
United States Site 275 Flushing New York
United States Site 297 Fort Worth Texas
United States Site 372 Gainesville Georgia
United States Site 368 Germantown Tennessee
United States Site 314 Hinsdale Illinois
United States Site 339 Indianapolis Indiana
United States Site 350 Irvine California
United States Site 364 La Jolla California
United States Site 279 Louisville Kentucky
United States Site 335 Miami Beach Florida
United States Site 121 Milwaukee Wisconsin
United States Site 281 Nashville Tennessee
United States Site 288 New Brunswick New Jersey
United States Site 300 Norfolk Virginia
United States Site 200 Overland Park Kansas
United States Site 334 Overland Park Kansas
United States Site 150 Palo Alto California
United States Site 318 Phoenix Arizona
United States Site 127 Pittsburgh Pennsylvania
United States Site 049 Portland Oregon
United States Site 280 Portland Oregon
United States Site 317 Portland Oregon
United States Site 276 Rapid City South Dakota
United States Site 365 Richmond Virginia
United States Site 392 San Antonio Texas
United States Site 014 San Francisco California
United States Site 278 San Francisco California
United States Site 291 Savannah Georgia
United States Site 316 Solvang California
United States Site 301 The Woodlands Texas
United States Site 277 Tucson Arizona
United States Site 346 Urbana Illinois
United States Site 042 Weston Florida

Sponsors (2)

Lead Sponsor Collaborator
Corcept Therapeutics Gynecologic Oncology Group

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  France,  Hungary,  Israel,  Italy,  Korea, Republic of,  Poland,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival as Assessed by BICR 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 Up to 24 months from enrollment of the last patient
Secondary Overall survival Time from randomization to death by any cause Up to 24 months from enrollment of the last patient
Secondary PFS as Assessed by the Investigator 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 Up to 24 months from enrollment of the last patient
Secondary Objective Response as Assessed by BICR Proportion of patients with measurable disease at baseline who attain CR or PR by RECIST v1.1. Up to 24 months from enrollment of the last patient
Secondary Best Overall Response as Assessed by BICR Proportion of patients with measurable disease at baseline who attain CR or PR as best response by RECIST v1.1. Up to 24 months from enrollment of the last patient
Secondary Duration of Response as Assessed by BICR Time from when response (CR or PR per RECIST v1.1) is first documented to first objectively documented PD or death (whichever occurs first) Up to 24 months from enrollment of the last patient
Secondary Clinical benefit rate as assessed by BICR Proportion of patients who attain CR, PR, or stable disease (SD) per RECIST v1.1. 24 weeks
Secondary Cancer Antigen (CA)-125 Response 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. Up to 24 months from enrollment of the last patient
Secondary Combined Response According to RECIST v1.1 and GCIG Criteria Combined response will be assessed for PD per RECIST v1.1 and for CA-125 response per GCIG criteria Up to 24 months from enrollment of the last patient
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06351475 - Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy N/A
Completed NCT00332696 - Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis Phase 2
Completed NCT00063401 - Phase II Study in Patients With Epidermal Growth Factor Receptor (EGFR) + Advanced Stage Ovarian, Primary Peritoneal and Fallopian Tube Cancer Phase 2
Completed NCT00216372 - Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis Phase 3
Completed NCT00035100 - EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer Phase 2
Completed NCT00317772 - Topotecan and Gefitinib (Iressa) for Ovarian, Peritoneal, or Fallopian Tube Cancer Phase 1/Phase 2
Completed NCT00382811 - OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer Phase 3
Completed NCT00074867 - Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Small-Volume Ovarian, Peritoneal, Fallopian Tube Cancer Phase 2
Completed NCT00191646 - An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy Phase 3
Completed NCT01846611 - A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Phase 3
Recruiting NCT05185947 - Study of Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis From Colorectal, Appendiceal, Small Bowel, Gastric, Cholangiocarcinoma, Breast, Ovarian, or Other Gynecologic Primary Cancer Phase 2
Completed NCT03246321 - PIPAC for Peritoneal Metastases of Colorectal Cancer Phase 2
Recruiting NCT04111978 - MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO) Phase 3
Recruiting NCT05617755 - AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients With Platinum Resistant Epithelial Ovarian Cancer Phase 1
Completed NCT01478685 - A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors Phase 1
Completed NCT02903771 - Phase I Study of Cantrixil in Patients With Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer. Phase 1
Completed NCT01462890 - Evaluation of Optimal Treatment Duration of Bevacizumab Combination With Standard Chemotherapy in Patients With Ovarian Cancer Phase 3
Withdrawn NCT01225757 - Comparison of Traditional and Echocardiography Guided Fluid Management During Cytoreductive Surgery With HIPEC N/A
Completed NCT00262990 - Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer Phase 3
Completed NCT00183794 - Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma Phase 2