Relapsed Solid Tumor / Refractory Solid Tumor
Conditions
Interventions
Drug: Abemaciclib
Administered orally
Other Name: LY2835219
Drug: Irinotecan
Administered intrevenously
Drug: Temozolomide
Administered orally
(Study Arms)
Experimental: Dose Escalation: Abemaciclib
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 =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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium, France, Germany, Italy, Japan, Spain, United States
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed