Phase 1  | 


Pediatric Cancer

CDK4 & 6 Inhibitor

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*

show modal icon NCT04238819
Key Inclusion Criteria
  • ≤18 years of age 
  • Body weight ≥10 kg and body surface area (BSA) ≥0.5 m2
  • Any relapsed/refractory malignant 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 combinations in the study part that is currently enrolling
    • Participants must have at least one measurable (per Response Evaluation Criteria in Solid Tumors [RECIST] v1.1 or Response Assessment in Neuro-Oncology [RANO]) or evaluable lesion
    • Participants must have had histologic verification of malignancy at original diagnosis or relapse, except:
      • Participants with extra-cranial germ-cell tumors who have elevations of serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
      • Participants with intrinsic brain stem tumors or participants with CNS-germ cell tumors and elevations of CSF or serum tumor markers including alpha-fetoprotein or beta-HCG
  • Lansky score ≥50 for participants ≤16 years of age, and Karnofsky score ≥50 for participants >16 years of age
  • Discontinued all previous treatments for cancer or investigational agents and recovered from acute effects to grade ≤1 at the time of enrollment
  • Able to swallow
  • Adequate hematologic and organ function ≤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 one cycle of treatment
  • Caregivers and participants willing to make themselves available for the duration of the trial
Key Exclusion Criteria
  • Tumor containing known somatic or germline retinoblastoma (RB) mutation 
  • Prior allogenic bone marrow or solid organ transplant
  • Live vaccination within 4 weeks prior to starting study treatment
  • History of syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest within the last 12 months
  • 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 conditions that would preclude participation in this study
  • 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
  • Prior treatment with a CDK4 & 6 inhibitor
  • Current enrollment in any other clinical study involving an investigational product or nonapproved use of a drug or device
  • Prior experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer
  • Part A only: Bowel obstruction
This clinical trial is being conducted globally.
Additional criteria not shown here may exist for individual parts of the study.
Abemaciclib is administered PO.
Irinotecan is administered intravenously.
Temozolomide is administered PO.
Contact the Lilly Oncology Clinical Trial Navigation Service

Visit for more information on this trial.

The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.