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JOURNAL ONKOLOGIE – STUDIE

A Study of Abemaciclib (LY2835219) in Combination With Temozolomide and Irinotecan and Abemaciclib in Combination With Temozolomide in Children and Young Adult Participants With Solid Tumors

Rekrutierend

NCT-Nummer:
NCT04238819

Studienbeginn:
November 2020

Letztes Update:
21.02.2021

Wirkstoff:
Abemaciclib, Irinotecan, Temozolomide

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 1

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 15)

Alle anzeigen

Studien-Informationen

Brief Summary:

The study's purpose is to see if the drug abemaciclib is safe and effective in combination

with temozolomide and irinotecan (Part A) and abemaciclib in combination with temozolomide

(Part B) in pediatric and young adult participants with relapsed/refractory solid tumors.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Body weight ≥10 kilograms and body surface area (BSA) ≥0.5 meters squared.

- Participants with any relapsed/refractory solid tumor (excluding lymphoma), including

central nervous system tumors, that have progressed on standard therapies and, in the

judgment of the investigator, are appropriate candidates for the experimental therapy

combination in the study part that is currently enrolling.

- A Lansky score ≥50 for participants ≤16 years of age, and 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.

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

study drug.

- Females of reproductive potential must have negative serum pregnancy test at baseline

(within 7 days prior to starting treatment).

- Both female and male participants of reproductive potential must agree to use highly

effective contraceptive precautions (and avoid sperm donation for males) during the

trial. For abemaciclib, females should use contraception for at least 3 weeks

following the last abemaciclib dose (males have no restriction for contraceptive use

following treatment with 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 (within 4 weeks prior to starting study treatment).

- Have a personal history of any of the following conditions within the last 12 months:

syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation,

or sudden cardiac arrest.

- 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 or viral load.

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

participation in this study.

- Have a bowel obstruction (Part A of this study only).

- Treated 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.

- 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

Secondary outcome:

1. Overall Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR) (Time Frame - Baseline through Disease Progression or Death (Estimated up to 24 Months)):
ORR: Percentage of Participants with Best Response of CR or PR

2. Duration of Response (DoR) (Time Frame - Date of First Evidence of a CR or PR 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 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 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, 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, and SD

5. 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.

Geprüfte Regime

  • Abemaciclib (LY2835219):
    Administered orally
  • Irinotecan:
    Administered IV
  • Temozolomide:
    Administered orally

Quelle: ClinicalTrials.gov


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