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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05440786
Recruitment Status : Recruiting
First Posted : July 1, 2022
Last Update Posted : May 20, 2024
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sarcoma, Ewing Neoplasm Metastasis Drug: Abemaciclib Drug: Irinotecan Drug: Temozolomide Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 20, 2022
Estimated Primary Completion Date : February 10, 2027
Estimated Study Completion Date : September 10, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Abemaciclib + Irinotecan +Temozolomide
Abemaciclib given orally in combination with irinotecan given IV and temozolomide given orally.
 Drug: Abemaciclib
Orally
Other Name: LY2835219

Drug: Irinotecan
IV

Drug: Temozolomide
Orally
Experimental: Irinotecan +Temozolomide
Irinotecan given IV and temozolomide orally.
 Drug: Irinotecan
IV

Drug: Temozolomide
Orally


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Baseline to objective progression or death due to any cause (estimated up to 11 months) ]
    PFS determined by blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Baseline to date of death due to any cause (estimated up to 45 months) ]
    OS

  2. Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR [ Time Frame: Baseline to measured progressive disease (estimated up to 11 months) ]
    ORR

  3. Duration of Response (DoR) [ Time Frame: 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) ]
    DoR

  4. Disease Control Rate (DCR) [ Time Frame: Baseline to measured progressive disease (estimated up to 11 months) ]
    DCR

  5. PFS [ Time Frame: Baseline to objective progression or death due to any cause (estimated up to 11 months) ]
    PFS determined by investigator assessment using RECIST 1.1

  6. Pharmacokinetics (PK): Minimum Plasma Concentration (Cmin) of Abemaciclib [ Time Frame: Cycle 3, Day 1 (21 day cycles) ]
    PK: Cmin of Abemaciclib

  7. Abemaciclib Product Acceptability [ Time Frame: Day 1 of Cycles 1 through 3 (21 day cycles) ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05440786


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05440786    
Other Study ID Numbers: 18434
J1S-MC-JP04 ( Other Identifier: Eli Lilly and Company )
First Posted: July 1, 2022    Key Record Dates
Last Update Posted: May 20, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Sarcoma
Sarcoma, Ewing
Neuroectodermal Tumors, Primitive, Peripheral
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
 Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Irinotecan
Temozolomide
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents