A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck

Lilly

Status and phase

Completed

Phase 2

Conditions

Cancer of Head and Neck

Esophageal Cancer

Gastric Cancer

Non Small Cell Lung Cancer

Ovarian Cancer

Prostate Cancer

Colorectal Cancer

Treatments

Drug: pegfilgrastim

Drug: LY2523355

Study type

Interventional

Funder types

Industry

Identifiers

NCT01059643

12848

I1Y-MC-JFBF (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to estimate the rate of response for patients with ovarian, non-small cell lung, prostate, colorectal, gastroesophageal, and head and neck cancers who are administered LY2523355.

Enrollment

103 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of ovarian, non-small cell lung, prostate, colorectal, gastroesophageal cancer (adenocarcinoma of the esophageal cancer, stomach, or gastroesophageal junction), or squamous cell cancer of the head and neck
Have measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines (except prostate cancer participants)
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Are willing to follow study procedures for the duration of the study
Are willing to use an approved contraceptive method during treatment and for 3 months after discontinuation of study treatment

Exclusion criteria

Have a serious preexisting medical condition that would preclude participation in the study
Are pregnant or lactating
Have received treatment within 28 days of first dose of LY2523355 with a drug that has not received regulatory approval for any indication
Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases
Have a second active primary malignancy or a history of a second malignancy requiring cytotoxic therapy
Have QTc interval greater than 470 millisecond (msec) or intraventricular conduction delay (IVCD) with QRS greater than 120 msec on screening electrocardiogram (ECG)
Have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (HIV) or viral (A, B, C) hepatitis
Participants with pneumonia, evidence of obstructive pneumonitis, other respiratory infections, or infection from other sources are to be excluded