Open label, multi-centre, Phase Ia/b adaptive design study with an initial 2-stage Dose Escalation Phase followed by a Dose Expansion Phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
PARP1 selective inhibitor
Yale Cancer Center - Yale New Haven Hospital
New Haven, Connecticut, United States
RECRUITINGTisch Cancer Institute Icahn School of Medicine at Mount Sinai
New York, New York, United States
Number of patients demonstrating dose limiting toxicities and SAEs
Number of patients demonstrating dose limiting toxicities and SAEs
Time frame: Through study completion, an average of 1 year
Number of patients exhibiting reduction in tumor size.
Objective Response Rate (ORR)
Time frame: Through study completion, an average of 1 year
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The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
RECRUITINGInstitut Bergonie
Bordeaux, France
RECRUITINGInstitut Godinot
Reims, France
RECRUITINGOrszagos Onkologiai Intezet
Budapest, Hungary
RECRUITINGSTART La Rioja, Hospital Universitario San Pedro
Logroño, La Rioja, Spain
RECRUITINGHospital Universitari Vall d'Hebron
Barcelona, Spain
RECRUITINGSTART Barcelona, CIOCC, Hospital Universitario Nou Delfos
Barcelona, Spain
RECRUITINGHospital Universitario Reina Sofía
Córdoba, Spain
RECRUITING...and 5 more locations