Not yet recruiting

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

I3Y-MC-JPCS - ClinicalTrials.gov - NCT04238819

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.
How long will I be in the trial?
Your participation in this trial could last up to 24 months, depending on your cancer type and how you and your tumor respond
Email
Not yet recruiting

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

I3Y-MC-JPCS - ClinicalTrials.gov - NCT04238819

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.
How long will I be in the trial?
Your participation in this trial could last up to 24 months, depending on your cancer type and how you and your tumor respond
Email

Key Requirements

Age :

< 18

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

< 18

Sex

All

Participants must

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

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)

Trial Summary

Conditions the trial is for

Solid Tumor, Pediatric Solid Tumors

What the trial is testing?

Abemaciclib, Irinotecan, Temozolomide

Could I receive a Placebo?

no

Enrollment Goal

60

Trial Dates

October 2020 - January 2023

Trial Phase

1

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

< 18

Sex

All

Participants must

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

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)

Trial Summary

Conditions the trial is for

Solid Tumor, Pediatric Solid Tumors

What the trial is testing?

Abemaciclib, Irinotecan, Temozolomide

Could I receive a Placebo?

no

Enrollment Goal

60

Trial Dates

October 2020 - January 2023

Trial Phase

1

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Trial Locations

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Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?