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A Phase 2 Indication Identification Study of LY2523355 in Patients With Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Ovarian Cancer, Non Small Cell Lung Cancer, Prostate Cancer, Colorectal Cancer, Gastric Cancer, Esophageal Cancer, Cancer of Head and Neck

Thank you

Trial Information

A Phase 2 Indication Identification Study of LY2523355 in Patients With Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck


Inclusion Criteria:



- Diagnosis of ovarian, non-small cell lung, prostate, colorectal, gastroesophageal
cancer, 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 patients)

- 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 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

- Patients with pneumonia, evidence of obstructive pneumonitis, other respiratory
infections, or infection from other sources are to be excluded

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of patients with a Complete Response (CR) or Partial Response (PR)

Outcome Time Frame:

Baseline assessment until first evidence of progressive disease

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1- 317-615-4559 Mon - Fri 9 AM to 5 PM (Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

12848

NCT ID:

NCT01059643

Start Date:

April 2011

Completion Date:

December 2012

Related Keywords:

  • Ovarian Cancer
  • Non Small Cell Lung Cancer
  • Prostate Cancer
  • Colorectal Cancer
  • Gastric Cancer
  • Esophageal Cancer
  • Cancer of Head and Neck
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Colorectal Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Head and Neck Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Ovarian Neoplasms
  • Prostatic Neoplasms

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Jacksonville, Florida  32256
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Athens, Georgia  30607
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Overland Park, Kansas  66210
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Metairie, Louisiana  70006
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bethesda, Maryland  20817
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Billings, Montana  59101
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cincinnati, Ohio  45267
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tulsa, Oklahoma  74136
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Greenville, South Carolina  29605
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Memphis, Tennessee  38138
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bedford, Texas  76022
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Little Rock, Arkansas  72205
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Coeur D'Alene, Idaho  83814
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Morgantown, West Virginia  26506