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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05440786
Registration number
NCT05440786
Ethics application status
Date submitted
28/06/2022
Date registered
1/07/2022
Date last updated
12/06/2024
Titles & IDs
Public title
CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma
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Scientific 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
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Secondary ID [1]
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J1S-MC-JP04
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Secondary ID [2]
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18434
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sarcoma, Ewing
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Neoplasm Metastasis
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Condition category
Condition code
Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Cancer
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Bone
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Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Irinotecan
Treatment: Drugs - Temozolomide
Experimental: Abemaciclib + Irinotecan +Temozolomide - Abemaciclib given orally in combination with irinotecan given IV and temozolomide given orally.
Experimental: Irinotecan +Temozolomide - Irinotecan given IV and temozolomide orally.
Treatment: Drugs: Abemaciclib
Orally
Treatment: Drugs: Irinotecan
IV
Treatment: Drugs: Temozolomide
Orally
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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PFS determined by blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)
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Timepoint [1]
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Baseline to objective progression or death due to any cause (estimated up to 11 months)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS
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Timepoint [1]
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Baseline to date of death due to any cause (estimated up to 45 months)
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Secondary outcome [2]
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Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR
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Assessment method [2]
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ORR
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Timepoint [2]
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Baseline to measured progressive disease (estimated up to 11 months)
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Secondary outcome [3]
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Duration of Response (DoR)
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Assessment method [3]
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DoR
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Timepoint [3]
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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)
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Secondary outcome [4]
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Disease Control Rate (DCR)
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Assessment method [4]
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DCR
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Timepoint [4]
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Baseline to measured progressive disease (estimated up to 11 months)
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Secondary outcome [5]
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PFS
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Assessment method [5]
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PFS determined by investigator assessment using RECIST 1.1
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Timepoint [5]
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Baseline to objective progression or death due to any cause (estimated up to 11 months)
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Secondary outcome [6]
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Pharmacokinetics (PK): Minimum Plasma Concentration (Cmin) of Abemaciclib
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Assessment method [6]
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PK: Cmin of Abemaciclib
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Timepoint [6]
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Cycle 3, Day 1 (21 day cycles)
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Secondary outcome [7]
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Abemaciclib Product Acceptability
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Assessment method [7]
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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.
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Timepoint [7]
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Day 1 of Cycles 1 through 3 (21 day cycles)
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Eligibility
Key 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
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Minimum age
1
Year
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Maximum age
39
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/09/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
10/09/2028
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Actual
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Sample size
Target
45
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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The Children's Hospital at Westmead - Westmead
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Recruitment hospital [2]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [3]
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Royal Children's Hospital - Melbourne
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment postcode(s) [3]
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3052 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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Indiana
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United States of America
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Missouri
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United States of America
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Rhode Island
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France
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Aquitaine
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France
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Rhône-Alpes
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Germany
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Baden-Württemberg
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Germany
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Nordrhein-Westfalen
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Germany
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Berlin
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Italy
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Lazio
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Italy
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Bologna
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Japan
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Hyogo
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Japan
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Tokyo
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Japan
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State/province [15]
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Fukuoka
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Spain
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State/province [16]
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Barcelona [Barcelona]
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Spain
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State/province [17]
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Catalunya [Cataluña]
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Country [18]
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Spain
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State/province [18]
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Madrid, Comunidad De
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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State/province [21]
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València
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05440786
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
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Address
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Country
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Phone
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1-317-615-4559
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT05440786
Download to PDF