Abemaciclib For Solid Tumors

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The purpose of this study is to determine the highest safe dose of abemaciclib in patients with relapsed or treatment refractory solid tumors given in combination with the chemotherapy drugs, irinotecan and temozolomide (Part A) or in combination with just temozolomide (Part B).

Eligibility & Criteria

IRB #:
20-017832
Official Title:
I3Y-MC-JPSC(d): A Phase 1b Dose Escalation Study of Abemaciclib in Combination With Temozolomide and Irinotecan (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients with Relapsed/Refractory Solid Tumors
Study Phase:
Phase I
Eligible Age Range:
2 - 18 Years
Gender:
All
Study Categories:

Visit Criteria

This study will enroll male and female patients 18 years and younger with any relapsed or treatment refractory solid tumor that have progressed on standard treatments. Subjects will receive abemaciclib (study drug) in combination with the chemotherapy drugs, irinotecan and temozolomide or just temozolomide. Subjects will be asked to keep a drug diary and write down information about side effects and when they took the study drug.  Study visits will also include the following assessments: blood tests, electrocardiograms (ECGs), and completion of palatability questionnaire.