Peritoneal Neoplasms Clinical Trial
Official 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 (ROSELLA)
Verified date | April 2024 |
Source | Corcept Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Corcept Therapeutics | Gynecologic Oncology Group |
United States, Argentina, Australia, Belgium, Brazil, Canada, France, Hungary, Israel, Italy, Korea, Republic of, Poland, Spain, United Kingdom,
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 |
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