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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to date of death due to any cause (estimated up to 45 months)

Awards & highlights

Study Summary

This trial is testing whether adding abemaciclib to chemotherapy helps treat Ewing's sarcoma that has come back or did not respond to treatment. Participation could last 11 months or longer.

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.Check my eligibility

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.See study design

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

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My steroid dose has been stable or decreasing for the last week.

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My doctor expects me to live at least 8 more weeks and I can complete a treatment cycle.

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I can swallow or have a tube for feeding.

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I stopped all cancer treatments 7 days ago and have recovered from immediate side effects.

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I can swallow pills without any issues.

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I have been diagnosed with Ewing's sarcoma or a similar tumor.

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My Ewing's sarcoma has not responded or has worsened after treatment.

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I can commit to the study's duration and follow all its procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to date of death due to any cause (estimated up to 45 months)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS)

Secondary outcome measures

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%

Platelet count decreased

14%

Dry mouth

14%

Weight decreased

14%

Dysgeusia

13%

Dyspnoea

12%

Abdominal pain upper

12%

Back pain

12%

Dizziness

11%

Pyrexia

11%

Dyspepsia

11%

Oedema peripheral

11%

Blood creatinine increased

10%

Pain

Stomatitis

Aspartate aminotransferase increased

Dry skin

Thrombocytopenia

Pruritus

Lacrimation increased

Dehydration

Alanine aminotransferase increased

Flatulence

Urinary tract infection

Upper respiratory tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Rash

Gastrooesophageal reflux disease

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Sepsis

Hip fracture

Pneumonitis

Fall

Lung infection

Pneumothorax

Febrile neutropenia

Respiratory tract infection

Haematotoxicity

Sinus bradycardia

Tachycardia

Large intestinal obstruction

Pancreatic enzyme abnormality

Pancreatitis

Varices oesophageal

Electrocardiogram abnormal

Liver function test abnormal

Renal function test abnormal

Bone pain

Muscular weakness

Acute kidney injury

Pulmonary embolism

Arterial thrombosis

Epilepsy

100%

80%

60%

40%

20%

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 4

~2680

Abemaciclib

2019

Completed Phase 2

~1710

Temozolomide

2010

Completed Phase 3

~1930

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,618 Previous Clinical Trials

3,201,515 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical research study open to the public?

"As seen on clinicaltrials.gov, recruitment is still in progress for this study which was initially posted to the database on September 20th 2022 and most recently updated November 22nd 2022."

Answered by AI

What potential hazards could arise from using Abemaciclib?

"Abemaciclib received a score of 2 on our safety measure as it is currently in Phase 2. There are some studies supporting the drug's security, however no data has been collected to demonstrate its efficacy yet."

Answered by AI

In how many healthcare centers is this clinical trial currently ongoing?

"This clinical trial is actively enrolling patients in Phoenix, Los Angeles and Indianapolis at relevant pediatric hospitals. Additionally, there are 5 other sites participating nationwide."

Answered by AI

How many participants are being included in this research project?

"Eli Lilly and Company are responsible for the conduct of this trial, which requires 45 patients that meet their criteria. The study will be administered from two sites: Phoenix Children's Hospital in Arizona and The Regents of the University of California - Los Angeles (UCLA Pediatrics) at Los Angeles."

Answered by AI

Are participants aged over 45 accepted for the trial?

"This trial only permits those between the age of one year and 39 years. Conversely, 194 studies are available for younger patients while 974 pertain to individuals aged 65 or older."

Answered by AI

Is it possible for me to join this clinical experiment?

"Prospective participants must meet two criteria; they must have neoplasm metastasis and be between one year old to 39 years of age. The total number of enrollments is limited to 45 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma

2022. "CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05440786.

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