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JOURNAL ONKOLOGIE – STUDIE

A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma

Rekrutierend

NCT-Nummer:
NCT04238819

Studienbeginn:
November 2020

Letztes Update:
17.04.2024

Wirkstoff:
Abemaciclib, Irinotecan, Temozolomide, Dinutuximab, GM-CSF

Indikation (Clinical Trials):
Neoplasms, Neuroblastoma

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

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 PM 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 39)

Universitaetsklinikum Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyAbgeschlossen» Google-Maps
Universitaetsklinikum Essen
45122 Essen
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-Maps
Charité Campus Virchow-Klinikum
13353 Berlin
(Berlin)
GermanyAbgeschlossen» 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
Kaiser Permanente Oakland
94611 Oakland
United StatesRekrutierend» Google-Maps
Kaiser Permanente Roseville
95661 Roseville
United StatesRekrutierend» Google-Maps
Kaiser Permanente Santa Clara
95051 Santa Clara
United StatesRekrutierend» Google-Maps
Connecticut Children's Medical Center
06106 Hartford
United StatesNoch nicht rekrutierend» Google-Maps
University of Chicago Medical Center
60637 Chicago
United StatesRekrutierend» Google-Maps
Riley Hospital for Children at Indiana University Health
46202 Indianapolis
United StatesRekrutierend» Google-Maps
University of Louisville, Norton Children's Research Institute
40202 Louisville
United StatesNoch nicht rekrutierend» Google-Maps
Children's Hospital & Medical Center
68114 Omaha
United StatesNoch nicht rekrutierend» Google-Maps
Cohen Children's Medical Center
11040 New Hyde Park
United StatesRekrutierend» Google-Maps
Atrium Health - Carolinas Medical Center
28203 Charlotte
United StatesRekrutierend» Google-Maps
Akron Children's Hospital
44308 Akron
United StatesNoch nicht rekrutierend» Google-Maps
Cincinnati Children's Hospital Medical Center
45229 Cincinnati
United StatesRekrutierend» Google-Maps
Nationwide Children's Hospital
43205 Columbus
United StatesRekrutierend» Google-Maps
Children's Hospital of Philadelphia (CHOP)
19104 Philadelphia
United StatesRekrutierend» Google-Maps
Lifespan Cancer Institute
02906 Providence
United StatesRekrutierend» Google-Maps
Intermountain - Primary Children's Hospital
84113 Salt Lake City
United StatesNoch nicht rekrutierend» Google-Maps
The Hospital for Sick Children
M5G 1X8 Toronto
CanadaNoch nicht rekrutierend» Google-Maps
CHU Sainte-Justine
H3T 1C5 Montreal
CanadaNoch nicht rekrutierend» Google-Maps
Fondazione Policlinico Universitario Agostino Gemelli
168 Roma
ItalyAbgeschlossen» Google-Maps
Hospital Universitari Vall d'Hebron
8035 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Infantil Universitario Niño Jesús
28009 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitari i Politecnic La Fe
46026 València
SpainAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The study's purpose is to see if the drug, abemaciclib, is safe and effective when given with

other drugs to kill cancer cells. The study is open to children and young adults with solid

tumors, including neuroblastoma, that did not respond or grew during other anti-cancer

treatment. For each participant, the study is estimated to last up to 2 years.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Parts A and B only:

- Participants must be less than or equal to (≤)18 years of age.

- Body weight greater than or equal to (≥)10 kilograms and body surface area (BSA)

≥0.5

- Participants with any relapsed/refractory malignant solid tumor (excluding

lymphoma), including central nervous system tumors, that have progressed on

standard therapies.

- For sites that are actively enrolling Parts B and C, participants with

neuroblastoma who are eligible for Part C will be excluded from Part B unless

approved by Lilly CRP/CRS.

- Part C only:

- Participants must be less than (<) 21 years of age.

- Participants have a BSA ≥0.2 m².

- Participants with first relapse/refractory neuroblastoma.

- All Parts

- Participants must have measurable or evaluable disease by RECIST v1.1 or RANO.

- A Lansky score ≥50 for participants <16 years of age or Karnofsky score ≥50 for

participants ≥16 years of age.

- Participants must have discontinued all previous treatments for cancer or

investigational agents and must have recovered from the acute effects to Grade ≤1

at the time of enrollment.

- Able to swallow and/or have a gastric/nasogastric tube.

- Adequate hematologic and organ function ≤2 weeks (14 days) prior to first dose of

study drug.

- Females of reproductive potential must have negative urine or serum pregnancy

test at baseline (within 7 days prior to starting treatment).

- Female participants of reproductive potential must agree to use highly effective

contraceptive precautions during the trial. For abemaciclib, females should use

contraception for at least 3 weeks following the last abemaciclib. For other

study drugs, highly effective contraceptive precautions (and avoiding sperm

donation) must be used according to their label.

- Life expectancy of at least 8 weeks and able to complete at least 1 cycle of

treatment.

- Caregivers and participants willing to make themselves available for the duration

of the trial.

Exclusion Criteria:

- Received allogenic bone marrow or solid organ transplant.

- Received live vaccination.

- Intolerability or hypersensitivity to any of the study treatments or its components.

- Diagnosed and/or treated additional malignancy within 3 years prior to enrollment that

may affect the interpretation of results, with the exception of curatively treated

basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or

curatively resected in situ cervical and/or breast cancers.

- Pregnant or breastfeeding.

- Active systemic infections.

- Serious and/or uncontrolled preexisting medical condition(s) that would preclude

participation in this study.

- Parts A and C only: Have a bowel obstruction.

- Prior treatment with drugs known to be strong inhibitors or inducers of isoenzyme

cytochrome P450 3A (CYP3A) or strong inhibitors of uridine diphosphate-glucuronosyl

transferase 1A1 (UGT1A1) if the treatment cannot be discontinued or switched to a

different medication at least 5 half-lives prior to starting study drug.

- Received prior treatment with cyclin-dependent kinase (CDK) 4 & 6 inhibitor.

- Part C only: Received prior systemic therapy for relapsed/refractory neuroblastoma.

- Part C only, have received prior anti-GD2 therapy during induction phase.

- Currently enrolled in any other clinical study involving an investigational product or

non-approved use of a drug or device.

- Has received an experimental treatment in a clinical trial within the last 30 days or

5 half-lives, whichever is longer.

Studien-Rationale

Primary outcome:

1. Number or Participants with Dose Limiting Toxicities (DLTs) (Time Frame - Cycle 1 (21 Day Cycle)):
Number of Participants with DLTs

2. Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib (Time Frame - Cycle 1 through Cycle 3 (21 Day Cycle)):
PK: Mean Steady State Concentrations of Abemaciclib

3. PK: Mean Steady State Concentrations of Irinotecan (Time Frame - Cycle 1 through Cycle 3 (21 Day Cycle)):
PK: Mean Steady State Concentrations of Irinotecan

4. PK: Mean Steady State Concentrations of Temozolomide (Time Frame - Cycle 1 through Cycle 3 (21 Day Cycle)):
PK: Mean Steady State Concentrations of Temozolomide

5. Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR), Partial Response (PR), or Minimal Response (MR): Part C, only (Time Frame - Baseline through Disease Progression or Death (Estimated up to 24 Months)):
ORR: Percentage of Participants with Best Response of CR, PR or MR per International Neuroblastoma Response Criteria (INRC)

Secondary outcome:

1. Overall Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR): Parts A and B, only (Time Frame - Baseline through Disease Progression or Death (Estimated up to 24 Months)):
ORR: Percentage of Participants with Best Response of CR or PR per Response Evaluation Criteria in Solid Tumors (RECIST) or Response Assessment in Neuro-Oncology (RANO)

2. Duration of Response (DoR) (Time Frame - Date of First Evidence of a CR, PR, or MR (Part C, only) to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 24 Months)):
DoR

3. Clinical Benefit Rate (CBR): Percentage of Participants with Best Overall Response of CR, PR, MR (Part C, only) or SD With a Duration of At Least 6 Months (Time Frame - Baseline through Disease Progression or Death Due to Any Cause (Estimated up to 24 Months)):
CBR: Percentage of Participants with Best Overall Response of CR, PR, MR (Part C, only) or SD With a Duration of at Least 6 Months

4. Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, MR (Part C, only), and Stable Disease (SD) (Time Frame - Baseline through Measured Progressive Disease (Estimated up to 24 Months)):
DCR: Percentage of Participants with a Best Overall Response of CR, PR, MR (Part C, only), and SD

5. Progression-Free Survival (PFS): Part C, Only (Time Frame - Baseline through Progressive Disease or Death (Estimated up to 24 Months)):
PFS

6. Acceptability Questionnaire (Time Frame - Cycle 2 Day 1 (21 Day Cycles)):
Participants were evaluated for abemaciclib acceptability (palatability and ease of administration) using a 5-category questionnaire. Participants were asked to answer one of the following to describe the acceptability of abemaciclib: Very difficult, difficult, neither easy nor difficult, easy, or very easy

Studien-Arme

  • Experimental: Dose Escalation: Abemaciclib + Irinotecan + Temozolomide
    Abemaciclib given orally, irinotecan given intravenously (IV) and temozolomide given orally.
  • Experimental: Dose Expansion: Abemaciclib + Irinotecan + Temozolomide
    Abemaciclib given orally, irinotecan given IV and temozolomide given orally.
  • Experimental: Dose Escalation: Abemaciclib + Temozolomide
    Abemaciclib and temozolomide given orally.
  • Experimental: Dose Expansion: Abemaciclib + Temozolomide
    Abemaciclib and temozolomide given orally.
  • Experimental: Part C Stage 1: Abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide
    Abemaciclib given orally, dinutuximab given IV, granulocyte macrophage colony-stimulating factor (GM-CSF) given subcutaneously (subQ), irinotecan given IV and temozolomide given orally or IV.
  • Experimental: Part C Stage 2: Abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide
    Abemaciclib given orally, dinutuximab given IV, GM-CSF given subQ, irinotecan given IV and temozolomide given orally or IV.

Geprüfte Regime

  • Abemaciclib (LY2835219):
    Administered orally
  • Irinotecan:
    Administered IV
  • Temozolomide:
    Administered orally or IV
  • Dinutuximab:
    Administered IV
  • GM-CSF:
    Administered subQ

Quelle: ClinicalTrials.gov


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