West Cancer Center

ADVANCED SOLID TUMORS: Phase 1; "I3Y-MC-JPBE"

Effects of CYP3A inhibition by clarithromycin on the pharmacokinetics of LY2835219 and its metabolites in cancer patients

Title

Eli Lilly I3Y-MC-JPBE

Study Title

Effects of CYP3A inhibition by clarithromycin on the pharmacokinetics of LY2835219 and its metabolites in cancer patients

Site Link

NCT02117648

Malignancy

z- Advanced Solid Tumors, Breast, Colon, Lung, Prostate, Sarcoma, Bladder, Kidney, Renal, Melanoma, Esophagus, Stomach, Head and Neck, Liver, Pancreatic

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

Any

Investigational Agent

LY2835219

Drug Class

CDK 4/6 Inhibitor

Daruka Mahadevan, MD, PhD

Sponsor

Eli Lilly and Company

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Metastatic solid tumors
ECOG PS 0-2
No symptomatic CNS disease

Objective

PK (AUC and Cmax) of LY2835219 in combination with clarithromycin

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Any solid tumor

Dosing Frequency

LY2835219 orally once every ~28 days

Control Agents

none

Study Protocol

Randomized