166
Participants
Start Date
October 27, 2025
Primary Completion Date
December 31, 2029
Study Completion Date
December 31, 2030
Stenoparib/Temozolomide
Stenoparib at the recommended phase 2 dose +Temozolomide 40mg/day daily will be given in combination x21 days each cycle
Lurbinectedin
Lurbinectedin 3.2mg/m2 one-hour intravenous (IV) infusion x 21 days each cycle
Stenoparib/Temozolomide
Patients will be assigned to one of three doses of Stenoparib (200mg po qd, 200mg po BID, and 200mg in am and 400mg in pm). The initial starting dose will be the 200 mg po QD orally daily for 21 days.
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA, Pittsburgh
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC, Salisbury
Jesse Brown VA Medical Center, Chicago, IL, Chicago
VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto
Richard L. Roudebush VA Medical Center, Indianapolis, IN, Indianapolis
Robley Rex VA Medical Center, Louisville, KY, Louisville
VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor
Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE, Omaha
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, Philadelphia
Michael E. DeBakey VA Medical Center, Houston, TX, Houston
VA Office of Research and Development
FED