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

NCT ID: NCT05440786

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-20
• Study Completion Date: 2028-09-30

Brief Summary

The purpose of this study is to measure the benefit of adding abemaciclib to chemotherapy (irinotecan and temozolamide) for Ewing's sarcoma that has come back or did not respond to treatment. This trial is part of the CAMPFIRE master protocol, which is a platform to speed development of new treatments for children and young adults with cancer. Your participation in this trial could last 11 months or longer, depending on how you and your tumor respond.

Conditions

Sarcoma, Ewing; Neoplasm Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abemaciclib + Irinotecan +Temozolomide

Abemaciclib given orally in combination with irinotecan given IV and temozolomide given orally.

Group Type: EXPERIMENTAL

Abemaciclib

Intervention Type: DRUG

Orally

Irinotecan

Intervention Type: DRUG

IV

Temozolomide

Intervention Type: DRUG

Orally

Irinotecan +Temozolomide

Irinotecan given IV and temozolomide orally.

Group Type: EXPERIMENTAL

Irinotecan

Intervention Type: DRUG

IV

Temozolomide

Intervention Type: DRUG

Orally

Interventions

Abemaciclib

Orally

Intervention Type: DRUG

Irinotecan

IV

Intervention Type: DRUG

Temozolomide

Orally

Intervention Type: DRUG

Other Intervention Names

LY2835219

Eligibility Criteria

Inclusion Criteria

• Diagnosis of Ewing's sarcoma or Ewing's sarcoma-like tumor by institutional pathologist. The original pathological report is required. Repeat biopsy at progression is not required
• Refractory disease or confirmed radiological progression or recurrence following first or later line of treatment of Ewing's sarcoma or Ewing's sarcoma-like tumor

-- Must have one measurable or evaluable lesion per RECIST 1.1

• Adequate performance status based on age

• For participants less than (<)16 years of age, a Lansky score greater than or equal to (≥)50, or
• For participants ≥16 years of age, a Karnofsky score ≥50
• Participants must have discontinued all previous treatments for cancer or investigational agents ≥7 days after the last dose and must have recovered from the acute effects
• Adequate hematologic and organ function less than or equal to (≤)14 days prior to Day 1 of Cycle 1:

• Absolute neutrophil count ≥1000/microliter (µL)
• Platelets ≥75,000/cubic millimeter (mm³)
• Hemoglobin ≥8 grams per deciLiter (g/Dl) (≥100 grams per Liter [g/L])
• Total bilirubin ≤1.5 times (×) upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN
• Creatinine clearance or calculated glomerular filtration rate (GFR) ≥60 milliliters per minute per square meter (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 kilograms (kg)
• Must be able to swallow and/or have a gastric/nasogastric tube

-- Participants in the European Union must be able to swallow intact capsules

• Stable or decreasing dose of steroids at least 7 days prior to enrollment
• Life expectancy of at least 8 weeks and able to complete at least 1 cycle of treatment
• Participants/caregivers are able and willing to make themselves available for the duration of the study and are willing to follow study procedures, including adherence to the pharmacokinetic (PK) sampling schedule

Exclusion Criteria

• Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
• Participants with an active fungal, bacterial, and/or known severe viral infection including, but not limited to, human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis.
• Participants who have had allogeneic bone marrow or solid organ transplant
• Surgery: Participants who have had, or are planning to have, the following invasive procedures:

• Major surgical procedure, laparoscopic procedure, or significant traumatic injury within 28 days prior to enrollment
• Surgical or other wounds must be adequately healed prior to enrollment
• Female participants who are pregnant or breastfeeding
• Have received any prior cyclin-dependent kinase (CDK) 4 and 6 inhibitor
• Progression during prior treatment with irinotecan and/or temozolomide
• Have a known intolerability or hypersensitivity to any of the study treatments or dacarbazine
• Diagnosed and/or treated additional malignancy within 3 years prior to enrollment

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Phoenix Children's Hospital

Phoenix, Arizona, United States

The Regents of the University of California - Los Angeles (UCLA Pediatrics)

Los Angeles, California, United States

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States

Washington University

St Louis, Missouri, United States

Lifespan Cancer Institute

Providence, Rhode Island, United States

The Children's Hospital at Westmead

Westmead, New South Wales, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Royal Children's Hospital

Melbourne, Victoria, Australia

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, Aquitaine, France

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, France

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Charité Campus Virchow-Klinikum

Berlin, , Germany

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Lazio, Italy

IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

Hyogo Prefectural Kobe Children's Hospital

Kobe, Hyōgo, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Kyushu University Hospital

Fukuoka, , Japan

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [Barcelona], Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [Cataluña], Spain

Hospital Infantil Universitario Niño Jesús

Madrid, Madrid, Comunidad de, Spain

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de, Spain

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Countries

United States; Australia; France; Germany; Italy; Japan; Spain

Related Links

https://trials.lillytrialguide.com/en-US/trial/6ZWD0uc8v7H8M6hyLyDv9e

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

Other Identifiers

J1S-MC-JP04

Identifier Type: OTHER

Identifier Source: secondary_id

2023-506772-28-00

Identifier Type: CTIS

Identifier Source: secondary_id

18434

Identifier Type: -

Identifier Source: org_study_id