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

• ClinicalTrials.gov Identifier: NCT05440786
• Recruitment Status: Recruiting
• First Posted: July 1, 2022
• Last Update Posted: October 23, 2023
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Contacts

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

United States, Indiana

Riley Hospital for Children at Indiana University Health; Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator: Melissa Bear

United States, Rhode Island

Lifespan Cancer Institute; Recruiting

Providence, Rhode Island, United States, 02906

Principal Investigator: Bradley DeNardo

Australia, New South Wales

Chris O'Brien Lifehouse; Recruiting

Camperdown, New South Wales, Australia, 2050

Principal Investigator: Vivek Bhadri

The Children's Hospital at Westmead; Recruiting

Westmead, New South Wales, Australia, 2145

Principal Investigator: Jessica Ryan

France

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest; Recruiting

Bordeaux, Aquitaine, France, 33076

Principal Investigator: Antoine Italiano

Centre Leon Berard; Recruiting

Lyon, Rhône-Alpes, France, 69373 CEDEX 08

Principal Investigator: Nadege Corradini

Japan

Hyogo Prefectural Kobe Children's Hospital; Recruiting

Kobe, Hyogo, Japan, 650-0047

Principal Investigator: Daiichiro Hasegawa

National Cancer Center Hospital; Recruiting

Chuo-ku, Tokyo, Japan, 104-0045

Principal Investigator: Chitose Ogawa

Kyushu University Hospital; Recruiting

Fukuoka, Japan, 812-8582

Principal Investigator: Yuhki Koga

Spain

Hospital de la Santa Creu i Sant Pau; Recruiting

Barcelona, Catalunya [Cataluña], Spain, 08041

Principal Investigator: Raul Teres Lleida

Sponsors and Collaborators

Eli Lilly and Company

Investigators

• 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

Additional Information:

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

• 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
• Last Update Posted: October 23, 2023
• Last Verified: October 2023

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/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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