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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

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ClinicalTrials.gov Identifier: NCT04238819
Recruitment Status : Not yet recruiting
First Posted : January 23, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE January 22, 2020
First Posted Date  ICMJE January 23, 2020
Last Update Posted Date March 17, 2020
Estimated Study Start Date  ICMJE May 15, 2020
Estimated Primary Completion Date February 17, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
  • Number or Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (21 Day Cycle) ]
    Number of Participants with DLTs
  • 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
  • PK: Mean Steady State Concentrations of Irinotecan [ Time Frame: Cycle 1 through Cycle 3 (21 Day Cycle) ]
    PK: Mean Steady State Concentrations of Irinotecan
  • PK: Mean Steady State Concentrations of Temozolomide [ Time Frame: Cycle 1 through Cycle 3 (21 Day Cycle) ]
    PK: Mean Steady State Concentrations of Temozolomide
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A Phase 1b Dose Escalation Study of Abemaciclib in Combination With Temozolomide and Irinotecan (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Relapsed Solid Tumor
  • Refractory Solid Tumor
Intervention  ICMJE
  • Drug: Abemaciclib
    Administered orally
    Other Name: LY2835219
  • Drug: Irinotecan
    Administered IV
  • Drug: Temozolomide
    Administered orally
Study Arms  ICMJE
  • Experimental: Dose Escalation: Abemaciclib + Irinotecan + Temozolomide
    Abemaciclib given orally, irinotecan given intravenously (IV) and temozolomide given orally.
    Interventions:
    • Drug: Abemaciclib
    • Drug: Irinotecan
    • Drug: Temozolomide
  • Experimental: Dose Expansion: Abemaciclib + Irinotecan + Temozolomide
    Abemaciclib given orally, irinotecan given IV and temozolomide given orally.
    Interventions:
    • Drug: Abemaciclib
    • Drug: Irinotecan
    • Drug: Temozolomide
  • Experimental: Dose Escalation: Abemaciclib + Temozolomide
    Abemaciclib and temozolomide given orally.
    Interventions:
    • Drug: Abemaciclib
    • Drug: Temozolomide
  • Experimental: Dose Expansion: Abemaciclib + Temozolomide
    Abemaciclib and temozolomide given orally.
    Interventions:
    • Drug: Abemaciclib
    • Drug: Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 22, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 15, 2022
Estimated Primary Completion Date February 17, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 experimental therapy.
  • 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.
  • Treated with drugs known to be strong inhibitors or inducers of isoenzyme cytochrome P450 3A (CYP3A) and 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 (4 months for studies conducted in Japan).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04238819
Other Study ID Numbers  ICMJE 16950
I3Y-MC-JPCS ( Other Identifier: Eli Lilly and Company )
2019-002931-27 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date March 15, 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP