NCT02392793 - Talazoparib Plus Irinotecan With or Without Temozolomide in Children With Refractory or Recurrent Solid Malignancies | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 25, 2015

Primary Completion Date

February 20, 2019

Study Completion Date

August 30, 2019

Conditions

Childhood Solid Tumors

Interventions

DRUG

Talazoparib

Given orally once or twice on day 1 (depending on the dose level), then daily on days 2-6.

DRUG

Irinotecan

Given intravenously daily, days 2-6 immediately following the talazoparib dose.

DRUG

Temozolomide

Given orally daily. Dose to be determined after MTD established with talazoparib plus irinotecan.

DRUG

Filgrastim

Given subcutaneously (SubQ) once per day starting 24-36 hours after last dose of chemotherapy and continuing until post-nadir ANC is \>2,000/μL, unless peg-filgrastim is given.

DRUG

Peg-filgrastim

Given subcutaneously (SubQ) once per day starting 24-36 hours after last dose of chemotherapy and continuing until post-nadir ANC is \>2,000/μL, unless filgrastim is given.

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis