Sarcoma, EwingPhase 2NCT05440786
CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma
A Phase 2 study testing Abemaciclib, Irinotecan and Temozolomide in people with Sarcoma, Ewing and Neoplasm Metastasis, run by Eli Lilly and Company at 29 sites in 7 countries.
Trial summary
The purpose of this study is to measure the benefit of adding abemaciclib to chemotherapy (irinotecan and temozolomide) for Ewing's sarcoma that has come back or did not respond to treatment. Read more about this study
- Who is it for?
- Ages 1 year to 39 years
- Conditions the study is for
- Sarcoma, Ewing, Neoplasm Metastasis
- What is being tested?
- Abemaciclib, Irinotecan and Temozolomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 29 sitesin 7 countries
- Study dates
- 20 Sep 2022to Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
29 sites in 7 countries.
29 sites in 7 countries
Spain11 sites
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña], 08041
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona], 08950
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, Comunidad de, 28009
Hospital Universitario La Paz
Madrid, Madrid, Comunidad de, 28046
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital General Universitario Gregorio Marañon
Madrid, 28009
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Virgen Del Rocio
Seville, 41013
Hospital Universitari i Politecnic La Fe
Valencia, 46026
United States5 sites
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202
The Regents of the University of California - Los Angeles (UCLA Pediatrics)
Los Angeles, California, 90095-1752
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Lifespan Cancer Institute
Providence, Rhode Island, 02906
Washington University
St Louis, Missouri, 63110
Australia3 sites
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Royal Children's Hospital
Melbourne, Victoria, 3052
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
Germany3 sites
Charité Campus Virchow-Klinikum
Berlin, 13353
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45122
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Japan3 sites
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Kyushu University Hospital
Fukuoka, 812-8582
Hyogo Prefectural Kobe Children's Hospital
Kobe, Hyōgo, 650-0047
France2 sites
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, Aquitaine, 33076
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, 69373 CEDEX 08
Italy2 sites
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168
About this study
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
The purpose of this study is to measure the benefit of adding abemaciclib to chemotherapy (irinotecan and temozolomide) 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
- Being tested
- Abemaciclib, Irinotecan, Temozolomide
- Medical subject headings
- Sarcoma, Ewing, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbemaciclibDrug
Also called LY2835219
Orally
IrinotecanDrug
IV
TemozolomideDrug
Orally
| Study group | Role | What they receive |
|---|---|---|
| Abemaciclib + Irinotecan +Temozolomide | Experimental | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.
* Abemaciclib: 55 mg/m² (milligrams per square meter), administered orally twice daily (BID) for less than (<18) years or 100 mg administered orally BID for greater than or equal to (≥)18 years.
* Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle.
* Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. Receives: Drug: Abemaciclib; Drug: Irinotecan; Drug: Temozolomide |
| Irinotecan +Temozolomide | Experimental | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.
* Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
* Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. Receives: Drug: Irinotecan; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) Assessed by Blinded Independent Review Committee (BIRC) by Bayesian Analysis
PFS was defined as the time from randomization until the first occurrence of documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause in absence of progressive disease, whichever came first. Progressive disease (PD) was defined as at least 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions. An event was considered when tumor progression or death occurred, with event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at date of their last adequate tumor assessment per RECIST v1.1 criteria, or date of randomization (whichever was later). Results were obtained using Bayesian analysis and are reported as posterior mean along with its 80% credible interval.
Measured: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months)
PFS Assessed by BIRC by Frequentist Analysis
PFS was defined as the time from randomization until the first occurrence of documented disease progression per RECIST v1.1 criteria, or death from any cause in absence of progressive disease, whichever came first. PD was defined as at least 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. An event was considered when tumor progression or death occurred, with the event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at the date of their last adequate tumor assessment per RECIST v1.1 criteria, or date of randomization (whichever was later). Results were obtained using frequentist analysis.
Measured: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months)
Secondary outcomes (11)
PFS Assessed by Investigator by Bayesian Analysis
PFS was defined as the time from randomization until the first occurrence of documented disease progression per RECIST v1.1 criteria, or death from any cause in absence of progressive disease, whichever came first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. An event was considered when tumor progression or death occurred, with the event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at the date of their last adequate tumor assessment per RECIST v1.1 criteria, or date of randomization (whichever was later). Results were obtained using Bayesian analysis and are reported as posterior mean along with its 80% credible interval.
Measured: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.39 Months)
PFS Assessed by Investigator by Frequentist Analysis
PFS was defined as the time from randomization until the first occurrence of documented disease progression per RECIST v1.1 criteria, or death from any cause in absence of progressive disease, whichever came first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. An event was considered when tumor progression or death occurred, with the event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever was later). Results were obtained using frequentist analysis.
Measured: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.39 Months)
Overall Survival (OS)
OS was defined as the time from date of randomization until death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data were censored on the last date the participant was known to be alive.
Measured: From Date of Randomization until Death Due to Any Cause (Up to 26.37 months)
Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) Assessed by BIRC
ORR was defined as the number of participants who achieved the best overall response of complete response (CR) or partial response (PR) as per RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
Measured: From Date of Randomization until Disease Progression, Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.36 Months)
ORR: Percentage of Participants Who Achieved a CR or PR Assessed by Investigator
ORR was defined as the number of participants who achieved the best overall response of CR or PR as per RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
Measured: From Date of Randomization until Disease Progression, Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.39 Months)
Duration of Response (DoR) Assessed by BIRC
DoR was defined as the time from the date that measurement criteria for CR or PR (whichever was first recorded) were first met until the first date that recurrent disease or documented disease progression was observed per RECIST v1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence. DoR was calculated for participants with only PR or CR. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Participants with an observed CR or PR, no confirmed disease progression per RECIST v1.1 criteria, and no death due to any cause were censored at the time of the last adequate post-baseline scan.
Measured: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up to 10.7 Months)
DoR Assessed by Investigator
DoR was defined as the time from the date that measurement criteria for CR or PR (whichever was first recorded) were first met until the first date that recurrent disease or documented disease progression was observed, per RECIST v1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence. DoR was calculated for participants with only PR or CR. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Participants with an observed CR or PR, no confirmed disease progression per RECIST v1.1 criteria, and no death due to any cause were censored at the time of the last adequate post-baseline scan.
Measured: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up to 12.7 Months)
Percentage of Participants With a Best Overall Response of CR, PR, Stable Disease (SD) or Non-CR/Non-PD: Disease Control Rate (DCR) Assessed by BIRC
Disease control rate (DCR) was the percentage of participants with a best overall response of CR, PR, SD or Non-CR/Non-PD as defined by RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Non-CR/Non-PD was defined as persistence of one or more non-target lesions and/or maintained tumor marker levels, but without sufficient progression to be considered PD and without complete disappearance to be CR.
Measured: From Date of Randomization until Disease Progression, or Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.36 Months)
Percentage of Participants With a Best Overall Response of CR, PR or SD: DCR Assessed by Investigator
DCR was the percentage of participants with a best overall response of CR, PR, or SD as defined by RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Measured: From Date of Randomization until Disease Progression, or Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.39 Months)
Pharmacokinetics (PK): Minimum Plasma Concentration (Cmin) of Abemaciclib
PK: Cmin of Abemaciclib were reported.
Measured: Pre-dose on Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1; End of irinotecan infusion on Cycle 2 Day 1 and Cycle 4 Day 1
Abemaciclib Product Acceptability
Participants were evaluated for abemaciclib acceptability by asking a question - " Was it easy or difficult for the study participant to swallow the abemaciclib today?" Participants or their caregivers or both could respond using the following possible answers: "Very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Acceptability was assessed for formulations: tablets, oral granules, and dispersed tablets.
Measured: Day 1 of Cycle 1 through Cycle 3 (21-day cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start20 Sep 2022
- Primary completion15 Jan 2025
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sarcoma, EwingStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440786
- Sponsor's protocol ID
- 18434
- Other IDs
- J1S-MC-JP04, 2023-506772-28-00, 2021-004734-11, U1111-1302-8098, 2023
- Status last verified
- Oct 2026
- First submitted
- 28 Jun 2022
- Last updated
- 20 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
- Expanded access
- Available