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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT05440786
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Neoplasm Metastasis
  • Sarcoma, Ewing

Eligibility Criteria

Sex
ALL
Age
1 Year - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    Orally
  • Irinotecan — DRUG
    IV
  • Temozolomide — DRUG
    Orally

Study Details

The purpose of this study is to measure the benefit of adding abemaciclib to chemotherapy (irinotecan and temozolomide) 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.

Key Dates

Start date
Sep 20, 2022
Status verified
Mar 2026
Primary completion
Jan 15, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
46 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Abemaciclib + Irinotecan +Temozolomide
    Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met. * Abemaciclib: 55 mg/m² (milligrams per square meter), administered orally twice daily (BID) for less than (\<18) years or 100 mg administered orally BID for greater than or equal to (≥)18 years. * Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle. * Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
  • Experimental: Irinotecan +Temozolomide
    Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met. * Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle. * Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.

Primary Outcome Measure

Progression Free Survival (PFS) Assessed by Blinded Independent Review Committee (BIRC) by Bayesian Analysis [ Time Frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona85016-
The Regents of the University of California - Los Angeles (UCLA Pediatrics)Los AngelesCalifornia90095-1752-
Riley Hospital for Children at Indiana University HealthIndianapolisIndiana46202-
Washington UniversitySt LouisMissouri63110-
Lifespan Cancer InstituteProvidenceRhode Island02906-

Find similar trials in Phoenix, AZ

By research site
Phoenix Children's Hospital· Phoenix, AZThe Regents of the University of California - Los Angeles (UCLA Pediatrics)· Los Angeles, CARiley Hospital for Children at Indiana University Health· Indianapolis, INWashington University· St Louis, MOLifespan Cancer Institute· Providence, RI

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