The purpose of this study is to measure the effect and safety of treatment with tuvusertib combined with either niraparib or lartesertib in participants with epithelial ovarian cancer and to assess any differences between tuvusertib monotherapy and combination therapy. The participants will previously have progressed while treated with a poly ADP ribose polymerase (PARP) inhibitor. The primary objectives of this study are to assess the effect of the treatment in terms of overall response, i.e. whether the tumor disappears, shrinks, remains unchanged, or gets worse and safety in terms of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Tuvusertib will be administered orally.
Niraparib will be administered orally. If selected from Part A, Niraparib will be administered orally in combination with Tuvusertib.
Lartesertib will be administered orally. If selected from Part A, Lartesertib will be administered orally in combination with Tuvusertib
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California San Francisco - UCSF Medical Center
San Francisco, California, United States
Centricity Research Cancer Center - DBA CRRI John B. Amos Cancer Center Research
Columbus, Georgia, United States
University of Chicago Comprehensive Cancer Center at Silver Cross - Carolyn J. Czerkies Pavilion
Chicago, Illinois, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Part A and Part B: Confirmed Objective Response (OR) According to RECIST v1.1 as Assessed by Investigator
Time frame: Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years
Part A and Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Related TEAEs
Time frame: Time from randomization to final assessment at end of safety follow-up visit, approximately up to 3.5 years
Part A and Part B: Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator
Time frame: Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years
Part A and Part B: Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator
Time frame: Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years
Part B: Overall Survival
OS is defined as the time from randomization to death due to any cause.
Time frame: Time from date of randomization to death, approximately 3.5 years
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