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

Neoplasm Metastasis Clinical Trial

Official title:

A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination With Irinotecan and Temozolomide in Participants With Relapsed or Refractory Ewing's Sarcoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05440786
• Other study ID #: 18434
• Secondary ID: J1S-MC-JP04
• Status: Recruiting
• Phase: Phase 2
• Start date: September 20, 2022
• Est. completion date: September 10, 2028

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: Clinicaltrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: September 10, 2028
• Est. primary completion date: February 10, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neuroectodermal Tumors, Primitive, Peripheral
• Sarcoma
• Sarcoma, Ewing

Intervention

Drug:
• Abemaciclib
Orally
• Irinotecan
IV
• Temozolomide
Orally

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Royal Children's Hospital	Melbourne	Victoria
Australia	The Children's Hospital at Westmead	Westmead	New South Wales
France	Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest	Bordeaux	Aquitaine
France	Centre Leon Berard	Lyon	Rhône-Alpes
Germany	Charité Campus Virchow-Klinikum	Berlin
Germany	Universitaetsklinikum Essen	Essen	Nordrhein-Westfalen
Germany	Universitaetsklinikum Freiburg	Freiburg	Baden-Württemberg
Italy	IRCCS Istituto Ortopedico Rizzoli	Bologna
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma	Lazio
Japan	Kyushu University Hospital	Fukuoka
Japan	Hyogo Prefectural Kobe Children's Hospital	Kobe	Hyogo
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalunya [Cataluña]
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]
Spain	Hospital Sant Joan de Déu	Esplugues de Llobregat	Barcelona [Barcelona]
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Infantil Universitario Niño Jesús	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario La Paz	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Hospital Universitari i Politecnic La Fe	València
United States	Riley Hospital for Children at Indiana University Health	Indianapolis	Indiana
United States	The Regents of the University of California - Los Angeles (UCLA Pediatrics)	Los Angeles	California
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Lifespan Cancer Institute	Providence	Rhode Island
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	PFS determined by blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)	Baseline to objective progression or death due to any cause (estimated up to 11 months)
Secondary	Overall Survival (OS)	OS	Baseline to date of death due to any cause (estimated up to 45 months)
Secondary	Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR	ORR	Baseline to measured progressive disease (estimated up to 11 months)
Secondary	Duration of Response (DoR)	DoR	Date of first evidence of CR or PR to date of disease recurrence, objective disease progression, or death due to any cause (estimated up to 11 months)
Secondary	Disease Control Rate (DCR)	DCR	Baseline to measured progressive disease (estimated up to 11 months)
Secondary	PFS	PFS determined by investigator assessment using RECIST 1.1	Baseline to objective progression or death due to any cause (estimated up to 11 months)
Secondary	Pharmacokinetics (PK): Minimum Plasma Concentration (Cmin) of Abemaciclib	PK: Cmin of Abemaciclib	Cycle 3, Day 1 (21 day cycles)
Secondary	Abemaciclib Product Acceptability	Participants evaluated abemaciclib acceptability (palatability and ease of administration) using a 5-category questionnaire. Participants were asked to select one of the following to describe the acceptability of abemaciclib: Very difficult, difficult, neither easy nor difficult, easy, or very easy.	Day 1 of Cycles 1 through 3 (21 day cycles)

External Links

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