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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

Titles & IDs
Public title
CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma
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
Secondary ID [1] 0 0
J1S-MC-JP04
Secondary ID [2] 0 0
18434
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcoma, Ewing 0 0
Neoplasm Metastasis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional(has expanded access)
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Baseline to objective progression or death due to any cause (estimated up to 11 months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Baseline to date of death due to any cause (estimated up to 45 months)
Secondary outcome [2] 0 0
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR
Timepoint [2] 0 0
Baseline to measured progressive disease (estimated up to 11 months)
Secondary outcome [3] 0 0
Duration of Response (DoR)
Timepoint [3] 0 0
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 outcome [4] 0 0
Disease Control Rate (DCR)
Timepoint [4] 0 0
Baseline to measured progressive disease (estimated up to 11 months)
Secondary outcome [5] 0 0
PFS
Timepoint [5] 0 0
Baseline to objective progression or death due to any cause (estimated up to 11 months)
Secondary outcome [6] 0 0
Pharmacokinetics (PK): Minimum Plasma Concentration (Cmin) of Abemaciclib
Timepoint [6] 0 0
Cycle 3, Day 1 (21 day cycles)
Secondary outcome [7] 0 0
Abemaciclib Product Acceptability
Timepoint [7] 0 0
Day 1 of Cycles 1 through 3 (21 day cycles)

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
Minimum age
1 Year
Maximum age
39 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2028
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
Royal Children's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
3052 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Rhode Island
Country [6] 0 0
France
State/province [6] 0 0
Aquitaine
Country [7] 0 0
France
State/province [7] 0 0
Rhône-Alpes
Country [8] 0 0
Germany
State/province [8] 0 0
Baden-Württemberg
Country [9] 0 0
Germany
State/province [9] 0 0
Nordrhein-Westfalen
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Italy
State/province [11] 0 0
Lazio
Country [12] 0 0
Italy
State/province [12] 0 0
Bologna
Country [13] 0 0
Japan
State/province [13] 0 0
Hyogo
Country [14] 0 0
Japan
State/province [14] 0 0
Tokyo
Country [15] 0 0
Japan
State/province [15] 0 0
Fukuoka
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona [Barcelona]
Country [17] 0 0
Spain
State/province [17] 0 0
Catalunya [Cataluña]
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid, Comunidad De
Country [19] 0 0
Spain
State/province [19] 0 0
Madrid
Country [20] 0 0
Spain
State/province [20] 0 0
Sevilla
Country [21] 0 0
Spain
State/province [21] 0 0
València

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
Clinicaltrials.gov@lilly.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05440786