JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

Studienbeginn:
September 2022

Letztes Update:
16.04.2024

Wirkstoff:
Abemaciclib, Irinotecan, Temozolomide

Indikation (Clinical Trials):
Neoplasm Metastasis, Sarcoma, Sarcoma, Ewing, Neuroectodermal Tumors, Primitive, Peripheral

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 2

Sponsor:
Eli Lilly and Company

Collaborator:
-

Studienleiter

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)
Study Director
Eli Lilly and Company

Kontakt

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Kontakt:
Phone: 1-317-615-4559
E-Mail: Clinicaltrials.gov@lilly.com» Kontaktdaten anzeigen

Studienlocations
(3 von 29)

Universitaetsklinikum Freiburg
79106 Freiburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps

Universitaetsklinikum Essen
45122 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps

Charité Campus Virchow-Klinikum
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps

Phoenix Children's Hospital
85016 Phoenix
United StatesRekrutierend» Google-Maps

The Regents of the University of California - Los Angeles (UCLA Pediatrics)
90095-1752 Los Angeles
United StatesRekrutierend» Google-Maps

Riley Hospital for Children at Indiana University Health
46202 Indianapolis
United StatesRekrutierend» Google-Maps

Washington University
63110 Saint Louis
United StatesRekrutierend» Google-Maps

Lifespan Cancer Institute
02906 Providence
United StatesRekrutierend» Google-Maps

The Children's Hospital at Westmead
2145 Westmead
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Peter MacCallum Cancer Centre
3000 Melbourne
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Royal Children's Hospital
3052 Melbourne
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Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
33076 Bordeaux
FranceRekrutierend» Google-Maps

Centre Leon Berard
69373 CEDEX 08 Lyon
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Fondazione Policlinico Universitario Agostino Gemelli
00168 Roma
ItalyRekrutierend» Google-Maps

IRCCS Istituto Ortopedico Rizzoli
40136 Bologna
ItalyRekrutierend» Google-Maps

Hyogo Prefectural Kobe Children's Hospital
650-0047 Kobe
JapanRekrutierend» Google-Maps

Kyushu University Hospital
812-8582 Fukuoka
JapanRekrutierend» Google-Maps

Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps

Hospital Sant Joan de Déu
08950 Esplugues de Llobregat
SpainRekrutierend» Google-Maps

Hospital de la Santa Creu i Sant Pau
08041 Barcelona
SpainRekrutierend» Google-Maps

Hospital Infantil Universitario Niño Jesús
28009 Madrid
SpainRekrutierend» Google-Maps

Hospital Universitario La Paz
28046 Madrid
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Hospital General Universitario Gregorio Marañon
28007 Madrid
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Hospital General Universitario Gregorio Marañon
28009 Madrid
SpainRekrutierend» Google-Maps

Hospital Universitario Fundación Jiménez Díaz
28040 Madrid
SpainRekrutierend» Google-Maps

Hospital Universitario La Paz
28046 Madrid
SpainRekrutierend» Google-Maps

Hospital Universitario Virgen Del Rocio
41013 Sevilla
SpainRekrutierend» Google-Maps

Hospital Universitari i Politecnic La Fe
46026 València
SpainRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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:

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.

Studien-Arme

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.

Geprüfte Regime

Abemaciclib (LY2835219):
Orally
Irinotecan:
IV
Temozolomide:
Orally

Quelle: ClinicalTrials.gov

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