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:
Eli Lilly and Company
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
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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:
MedlinePlus related topics:
Cancer
Colorectal Cancer
Esophageal Cancer
Esophagus Disorders
Head and Neck Cancer
Lung Cancer
Ovarian Cancer
Prostate Cancer
Stomach Cancer
Drug Information available for:
Pegfilgrastim
U.S. FDA Resources
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
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 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 Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic |
Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Neoplasms, Squamous Cell Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013