← Back to Search

Alkylating Agent

Abemaciclib + Chemotherapy for Sarcoma

Phase 2
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate hematologic and organ function ≤14 days prior to Day 1 of Cycle 1: Absolute neutrophil count ≥1000/µL, Platelets ≥75,000/mm³, Hemoglobin ≥8 g/dL, Total bilirubin ≤1.5 × ULN, AST and ALT ≤3 × ULN, Creatinine clearance or calculated GFR ≥60 mL/min/m² or serum creatinine based on age/gender, Female participants of childbearing potential must have a negative urine or serum pregnancy test, Body weight ≥10 kg
Stable or decreasing dose of steroids at least 7 days prior to enrollment
Must not have
Female participants who are pregnant or breastfeeding
Progression during prior treatment with irinotecan and/or temozolomide
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to date of death due to any cause (estimated up to 45 months)
Awards & highlights

Summary

This trial is testing whether adding a new drug called abemaciclib to standard cancer treatments can help children and young adults with Ewing's sarcoma that has come back or did not respond to previous treatments. Abemaciclib works by blocking proteins that help cancer cells grow, which may slow down or stop the tumor. Participation could last several months or more, depending on individual responses.

Who is the study for?
This trial is for individuals with Ewing's Sarcoma that has returned or didn't respond to treatment. They must have a measurable tumor, weigh at least 10 kg, and have adequate organ function. Participants need to be off previous cancer treatments for at least 7 days and recovered from their effects. Pregnant or breastfeeding women can't join, nor can those who've had certain surgeries recently or are dealing with severe infections like HIV.
What is being tested?
The study tests the effectiveness of adding abemaciclib to chemotherapy drugs irinotecan and temozolomide in treating Ewing's Sarcoma. It's part of a larger effort called CAMPFIRE designed to accelerate new cancer treatments for young people.
What are the potential side effects?
Possible side effects include nausea, vomiting, diarrhea (from irinotecan), fatigue, low blood cell counts leading to increased infection risk (from temozolomide), and potential liver issues (from abemaciclib). Each drug may cause other unique side effects as well.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My steroid dose has been stable or decreasing for the last week.
Select...
My doctor expects me to live at least 8 more weeks and I can complete a treatment cycle.
Select...
I can swallow or have a tube for feeding.
Select...
I stopped all cancer treatments 7 days ago and have recovered from immediate side effects.
Select...
I can swallow pills without any issues.
Select...
I have been diagnosed with Ewing's sarcoma or a similar tumor.
Select...
My Ewing's sarcoma has not responded or has worsened after treatment.
Select...
I can commit to the study's duration and follow all its procedures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant or breastfeeding.
Select...
My condition worsened despite previous treatments with irinotecan or temozolomide.
Select...
I do not have any severe infections like HIV or hepatitis.
Select...
I have previously taken medication that targets CDK 4 and 6.
Select...
I have had a bone marrow or organ transplant from another person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to date of death due to any cause (estimated up to 45 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to date of death due to any cause (estimated up to 45 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
Abemaciclib Product Acceptability
Disease Control Rate (DCR)
Duration of Response (DoR)
+4 more

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490
91%
Diarrhoea
67%
Nausea
48%
Fatigue
45%
Decreased appetite
35%
Vomiting
27%
Anaemia
26%
Abdominal pain
23%
Asthenia
23%
Neutrophil count decreased
21%
Cough
20%
Constipation
20%
Headache
19%
Arthralgia
18%
White blood cell count decreased
18%
Neutropenia
15%
Alopecia
14%
Dry mouth
14%
Platelet count decreased
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Oedema peripheral
11%
Dyspepsia
11%
Pyrexia
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Rash
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Pneumonitis
1%
Pneumothorax
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib

Trial Design

2Treatment groups
Experimental Treatment
Group I: Irinotecan +TemozolomideExperimental Treatment2 Interventions
Irinotecan given IV and temozolomide orally.
Group II: Abemaciclib + Irinotecan +TemozolomideExperimental Treatment3 Interventions
Abemaciclib given orally in combination with irinotecan given IV and temozolomide given orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
2017
Completed Phase 3
~2580
Abemaciclib
2019
Completed Phase 2
~1800
Temozolomide
2010
Completed Phase 3
~1880

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Ewing Sarcoma include chemotherapy agents such as irinotecan and temozolomide, which work by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate and leading to cell death. Additionally, investigational treatments like CDK4/6 inhibitors, such as abemaciclib, target specific proteins involved in cell cycle regulation. By inhibiting CDK4/6, these agents prevent cancer cells from progressing through the cell cycle, effectively halting their growth and proliferation. This is particularly important for Ewing Sarcoma patients as these treatments can potentially improve outcomes by targeting the cancer cells more precisely and reducing the likelihood of resistance to therapy.
The role of abemaciclib in treatment of advanced breast cancer.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,640 Previous Clinical Trials
3,221,599 Total Patients Enrolled
Study DirectorEli Lilly and Company
1 Previous Clinical Trials
105 Total Patients Enrolled

Media Library

Ewing Sarcoma Clinical Trial 2023: Irinotecan Highlights & Side Effects. Trial Name: NCT05440786 — Phase 2
~24 spots leftby Feb 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top