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
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
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, Pediatric Cancer
What the trial is testing?
Abemaciclib, Irinotecan, Temozolomide
Could I receive a Placebo?
no
Enrollment Goal
60
Trial Dates
November 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, Pediatric Cancer
What the trial is testing?
Abemaciclib, Irinotecan, Temozolomide
Could I receive a Placebo?
no
Enrollment Goal
60
Trial Dates
November 2020 - January 2023
Trial Phase
1
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Trial Locations
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