A Study of LY3200882 in Participants With Solid Tumors

Phase 1Active Not RecruitingNCT02937272

Eli Lilly and Company223 enrolled

Overview

The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

223

Conditions

Solid Tumor

Interventions

LY3200882DRUG

Administered orally

LY3300054DRUG

Administered intravenously

GemcitabineDRUG

Administered intravenously

nab-Paclitaxel

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The participant must have histological or cytological evidence of cancer. * Have adequate organ function. * Have Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1. * Are able to swallow capsules and tablets. Exclusion Criteria: * Have moderate or severe cardiovascular disease. * Have a serious concomitant systemic disorder. * Have acute leukemia.

Locations (18)

University of Louisville

Louisville, Kentucky, United States

Weill Cornell Medical College

New York, New York, United States

Outcomes

Primary Outcomes

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

Time frame: Cycle 1 (28 days)

Part B: Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)

Time frame: Baseline through Disease Progression or Death (estimated at up to 12 months)

Secondary Outcomes

Pharmacokinetics (PK): Area Under the Curve (AUC) (AUC[0-24]) at Steady State of LY3200882

Time frame: Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)

PK: AUC Zero to Infinity (AUC[0-∞]) at Steady State of LY3200882

Time frame: Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)

ORR: Percentage of Participants with CR or PR

Time frame: Baseline through Disease Progression or Death (estimated at up to 12 months)

Overall Survival (OS)

Time frame: Baseline to Date of Death from Any Cause (estimated at up to 12 months)

Duration of Response (DoR)

Time frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 12 months)

Progression-Free Survival (PFS)

Time frame: Baseline to Disease Progression or Death (estimated at up to 12 months)

Data from ClinicalTrials.gov

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