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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01059643
First received: January 11, 2010
Last updated: April 30, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Non Small Cell Lung Cancer
Prostate Cancer
Colorectal Cancer
Gastric Cancer
Esophageal Cancer
Cancer of Head and Neck
Drug: LY2523355
Drug: pegfilgrastim
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percentage of patients with a Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline assessment until first evidence of progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: Date of enrollment to the first date of progressive disease or death due to any cause ] [ Designated as safety issue: No ]
  • Percentage of patients who achieved a best response of CR, PR or Stable Disease (SD) [ Time Frame: Baseline assessment until first evidence of progressive disease ] [ Designated as safety issue: No ]
  • Change in tumor marker values as relevant to specific tumor types [ Time Frame: Baseline assessment until first evidence of progressive disease ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) of LY2523355 and metabolite LSN2546307 [ Time Frame: Baseline to Day 8 of Cycle 1 ] [ Designated as safety issue: No ]
  • Change in tumor size at best response [ Time Frame: Baseline assessment until cycle with maximum change from baseline ] [ Designated as safety issue: No ]
  • Intracycle accumulation ratio of LY2523355 [ Time Frame: Day 1 to Day 3 of Cycle 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2523355 Drug: LY2523355
Dose determined by patient body surface area: 5 mg/m2, administered intravenously on days 1, 2, 3 of a 21 day cycle; for up to 2 cycles (4 cycles for prostate cancer patients). Additional cycles administered based on patient response assessment.
Drug: pegfilgrastim
6 mg, administered subcutaneously 24 hours after third dose of LY2523355 on day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer patients). Additional cycles of LY2523355 administered based on patient response assessment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059643

Locations
United States, Arkansas
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.
Jonesboro, Arkansas, United States, 72401
United States, Florida
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, United States, 32256
United States, Georgia
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.
Macon, Georgia, United States, 31201
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.
Marietta, Georgia, United States, 30060
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.
Valdosta, Georgia, United States, 31602
United States, Idaho
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.
Post Falls, Idaho, United States, 83854
United States, Kansas
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.
Westwood, Kansas, United States, 66205
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.
Wichita, Kansas, United States, 67214
United States, Louisiana
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.
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
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, United States, 20817
United States, Montana
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, United States, 59102
United States, Ohio
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.
Columbus, Ohio, United States, 43219
United States, Oklahoma
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.
Oklahoma City, Oklahoma, United States, 73120
United States, South Carolina
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.
Charleston, South Carolina, United States, 29425
United States, Tennessee
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.
Germantown, Tennessee, United States, 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.
Memphis, Tennessee, United States, 38120
United States, Texas
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.
Corpus Christi, Texas, United States, 78404
United States, West Virginia
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, United States, 26506
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01059643     History of Changes
Other Study ID Numbers: 12848, I1Y-MC-JFBF
Study First Received: January 11, 2010
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Colorectal Neoplasms
Esophageal Neoplasms
Head and Neck Neoplasms
Ovarian Neoplasms
Prostatic Neoplasms
Stomach Neoplasms
Adnexal Diseases
Bronchial Neoplasms
Carcinoma
Carcinoma, Bronchogenic
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Female
Genital Diseases, Male
Genital Neoplasms, Female
Genital Neoplasms, Male
Gonadal Disorders
Intestinal Diseases
Intestinal Neoplasms
Lung Diseases
Lung Neoplasms
Neoplasms

ClinicalTrials.gov processed this record on October 30, 2014