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Solid Tumor

A Study of Abemaciclib (LY2835219) in Combination With Temozolomide and Irinotecan and Abemaciclib in Combination With Temozolomide in Children and Young Adult Participants With Solid Tumors

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Study Purpose

The study’s purpose is to see if the drug abemaciclib is safe and effective in combination with temozolomide and irinotecan (Part A) and abemaciclib in combination with temozolomide (Part B) in pediatric and young adult participants with relapsed/refractory solid tumors.

Time Commitment

Your participation in this trial could last up to 24 months, depending on your cancer type and how you and your tumor respond

Key Participation Requirements Tool Tip Icon

All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria

Gender

Male Female

Age

≤18 years

-Participants must have body weight ≥10 kg and BSA ≥ 0.5 m2

-Participants must have diagnosis of relapsed/refractory solid tumor

-Participants must have discontinued all previous treatments for cancer

-Participants must have a life expectancy of at least 8 weeks

-Participants must not have received a bone marrow or organ transplant

-Participants must not have received a live vaccination within 4 weeks of starting the study

-Participants must not be pregnant or breastfeeding

-Participants must not have a personal history of specific illnesses such as certain cardiovascular disorders, severe renal impairment, interstitial lung disease, and certain gastrointestinal disorders

-Participants must not have active systemic infections or viral loads

-Participants must not have diagnosed and/or treated additional malignancy within 3 years prior to enrollment (with some exceptions)

Where to Participate

Where to Participate

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