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LACOG 0223 / GOG-3073 – ROSELLA

  /    /  LACOG 0223 / GOG-3073 – 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

Type of Study: Clinical Trial

Sponsor / Support: Corcept Therapeutics, GOG, LACOG and EVA – Grupo Brasileiro de Tumores Ginecológicos

Primary Objectives: To evaluate progression-free survival (PFS) by BICR in patients treated with intermittent regimen of relacorilant in combination nab-paclitaxel compared with patients trated with nab-paclitaxel monotherapy.

Design: This is a Phase 3, randomized, two-arm, open-label study

Sample Size: 360 patients (52 – Brazil)

Principal Investigator:  Mariana Scaranti

Countries LATAM: Brazil

Clinicaltrials.gov Identifier: NCT05257408

The study is open to patients participation in the following research sites:

Oncocentro Ceará / Fortaleza / CE / Brazil

OncoStar Rede D'or / Brasília / DF / Brazil

Hospital Alemão Oswaldo Cruz / São Paulo / SP / Brazil

Clínica AMO - Assistência Multidisciplinar em Oncologia / Salvador / BA / Brazil

BP - A Beneficência Portuguesa de São Paulo / São Paulo / SP / Brazil

Liga Norte Riograndense Contra o Câncer / Natal / RN / Brazil

Hospital Nove de Julho / São Paulo / SP / Brazil

Hospital Moinhos de Vento / Porto Alegre / RS / Brazil

A.C Camargo Cancer Center / São Paulo / SP / Brazil

Ongoing studies

Breast
GBECAM 0115 – AMAZONA III
LACOG 0115 – LORELEI
LACOG 0221 – BRAVE
LACOG 0413 – Male Breast Cancer
LACOG 0419 – NEOSAMBA
LACOG 0615 – LATINABreast
LACOG 0715 – PALLAS
LACOG 0721 – Cherry Pick
LACOG 2118 – ALEXANDRA/IMpassion 030

Gastrointestinal
LACOG/GTG 0119 – NET
LACOG 0222 – GASPAR
LACOG 0421 – ACTION HIV
LACOG/GTG 1318 – Anal Registry

Genitourinary
LACOG 0121 – PET-PSMA
LACOG 0217 – IRONMAN
LACOG 0218 – Hercules
LACOG 0519 – PEACE III
LACOG 0522 – DORA
LACOG 0620 – ExBAT
LACOG 1120 – RENAL REGISTRY
LACOG 1818 – Prostate Cancer Registry
LACOG 2018 – Foundation Penile

Gynecological
LACOG 0223 / GOG-3073 – ROSELLA
LACOG 0521 – MADONNA
LACOG 0623 – eVOLVE-Cervical
LACOG 0820 – EVITA LATAM
LACOG 0920 – Senticol III
LACOG 1018 – PALBO in Ovarian Cancer
LACOG 1220 – CONOR

Head and Neck
LACOG 0319
LACOG 0720 – SMART-KEY

Lung
LACOG 0116 – LATINO LUNG
LACOG 0118 – RELANCE
LACOG 0120 – EAP durva lung cancer
LACOG 0322 – EDUR-BRA
LACOG 0821
LACOG 1918
LACOG 2218 – PACIFIC BRAZIL

Radiation
LACOG 0122 – RADIANT

Closed studies

Breast
LACOG 0111 – MGH
LACOG 0312 – METASTATIC BC
LACOG 0414
LACOG 0801 – GLICO

Genitourinary
LACOG 0415 – APA in Prostate Cancer
LACOG 0515 – Testicular Registry
LACOG 1518 – Bladder Cancer Registry

Gynecological
LACOG 0215 – EVITA

Head and Neck
LACOG 0318 – Induction

Lung
LACOG 0211 – ALK
LACOG 0417 – CNS MTX
LACOG 0618
Parsimony

Neuro
LACOG 0619

Other studies
LACOG 0213 – AUGMENT
LACOG 0214 – FINEP