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

JRCT ID: jRCT2031210562

Registered date:19/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Relapsed Solid Tumor / Refractory Solid Tumor
• Date of first enrollment: 09/11/2020
• Target sample size: 60
• Countries of recruitment: Belgium,Japan,France,Japan,Germany,Japan,Italy,Japan,Spain,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: Abemaciclib
Administered orally
Other Name: LY2835219
Drug: Irinotecan
Administered intrevenously
Drug: Temozolomide
Administered orally

(Study Arms)
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.

Outcome(s)

Primary Outcome

Number of Participants with DLTs
PK: Mean Steady State Concentrations of Abemaciclib
PK: Mean Steady State Concentrations of Irinotecan
PK: Mean Steady State Concentrations of Temozolomide

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 18age old
• Gender: Both

Include criteria

Body weight >=10 kilograms and body surface area (BSA) >=0.5 meters squared.

Participants with 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 combination in the study part that is currently enrolling.

Participants must have at least one measurable (per Response Criteria in Solid Tumors [RECIST v1.1; [Eisenhauer et al. 2009] or Response Assessment in Neuro-Oncology (RANO) for central nervous system (CNS) tumors [Wen et al. 2010]) 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.

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.

Exclude criteria

Received allogenic bone marrow or solid organ transplant.

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.

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.

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.

Tumor contains known somatic or germline retinoblastoma (RB) mutation.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT04238819