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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05999994




Registration number
NCT05999994
Ethics application status
Date submitted
14/08/2023
Date registered
21/08/2023

Titles & IDs
Public title
A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer
Scientific title
CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Research
Secondary ID [1] 0 0
J1S-MC-JAAA
Secondary ID [2] 0 0
17304
Universal Trial Number (UTN)
Trial acronym
CAMPFIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Child 0 0
Adolescent 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Ramucirumab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Vinorelbine
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Docetaxel
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Irinotecan
Treatment: Drugs - Temozolomide

Experimental: Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA) - Ramucirumab given intravenously (IV), cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for desmoplastic small round cell tumor (DSRCT) intervention-specific appendix (ISA).

Active comparator: Cyclophosphamide + Vinorelbine (DSRCT ISA) - Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA.

Experimental: Ramucirumab + Gemcitabine + Docetaxel (SS ISA) - Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.

Active comparator: Gemcitabine + Docetaxel (SS ISA) - Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA.

Experimental: Abemaciclib + Irinotecan + Temozolomide (ES ISA) - Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.

Active comparator: Irinotecan + Temozolomide (ES ISA) - Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.


Treatment: Drugs: Ramucirumab
Administered IV

Treatment: Drugs: Cyclophosphamide
Administered orally

Treatment: Drugs: Vinorelbine
Administered IV

Treatment: Drugs: Gemcitabine
Administered IV

Treatment: Drugs: Docetaxel
Administered IV

Treatment: Drugs: Abemaciclib
Administered orally

Treatment: Drugs: Irinotecan
Administered IV

Treatment: Drugs: Temozolomide
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Allocated to Each ISA
Timepoint [1] 0 0
Baseline up to Week 4

Eligibility
Key inclusion criteria
Participants must meet all of the inclusion criteria below. Additional criteria are specified in the protocol amendment (individual addenda) to which the participant will enroll.

* Have either measurable or evaluable disease using standard techniques by the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
* The participant has a Lansky (<16 years of age) or Karnofsky (=16 years of age) performance score of at least 50.
* Participants must have discontinued all previous treatments for cancer or investigational agents greater than or equal to (=)7 days after the last dose and must have recovered from clinically significant side effects.
* The participant has adequate hematologic and organ function.
* Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to first dose.
* Both female and male participants of childbearing potential must agree to use highly effective contraceptive precautions during the trial and for at least 3 months following the last dose of study drug.

Participants will be ineligible if they meet any of the exclusion criteria below. Additional criteria are specified in the protocol amendment to which the participant will enroll.

* 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 who have active infections requiring therapy.
* Participants who have had allogeneic bone marrow or solid organ transplant.
* Participants who have had, or are planning to have, certain invasive procedures.
* Female participants who are pregnant or breastfeeding.
Minimum age
1 Year
Maximum age
39 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
22/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2027
Actual
Sample size
Target
105
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
The Sydney Children's Hospitals Network - Westmead
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 0 0
Royal Children's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
3052 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
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Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
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Indiana
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United States of America
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Massachusetts
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United States of America
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Michigan
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Minnesota
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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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New York
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United States of America
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Ohio
Country [16] 0 0
United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Rhode Island
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United States of America
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Texas
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United States of America
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Washington
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United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Belgium
State/province [22] 0 0
Oost-Vlaanderen
Country [23] 0 0
Belgium
State/province [23] 0 0
Bruxelles
Country [24] 0 0
France
State/province [24] 0 0
Aquitaine
Country [25] 0 0
France
State/province [25] 0 0
Rhône-Alpes
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
Germany
State/province [27] 0 0
Baden-Württemberg
Country [28] 0 0
Germany
State/province [28] 0 0
Essen
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Germany
State/province [29] 0 0
Hamburg
Country [30] 0 0
Italy
State/province [30] 0 0
Lombardie
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Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Italy
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Torino
Country [33] 0 0
Italy
State/province [33] 0 0
Veneto
Country [34] 0 0
Italy
State/province [34] 0 0
Bologna
Country [35] 0 0
Italy
State/province [35] 0 0
Roma
Country [36] 0 0
Japan
State/province [36] 0 0
Hyogo
Country [37] 0 0
Japan
State/province [37] 0 0
Tokyo
Country [38] 0 0
Japan
State/province [38] 0 0
Fukuoka
Country [39] 0 0
Netherlands
State/province [39] 0 0
Zuid-Holland
Country [40] 0 0
Netherlands
State/province [40] 0 0
Utrecht
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Spain
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Barcelona [Barcelona]
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Spain
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Madrid, Comunidad De
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Spain
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Santa Cruz De Tenerife
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Spain
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Barcelona
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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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València
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United Kingdom
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Greater London
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United Kingdom
State/province [49] 0 0
London
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United Kingdom
State/province [50] 0 0
Manchester

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
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 European Union (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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05999994