A Study for Patients With Small-Cell Lung Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01025284
First received: December 1, 2009
Last updated: January 11, 2013
Last verified: October 2012
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Purpose
Part A: This study evaluates an experimental treatment in patients with extensive-disease in small-cell lung cancer.
Part B: This study evaluates an experimental treatment in patients with extensive-disease in small-cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Small Cell Lung Cancer |
Drug: LY2523355 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of LY2523355 in Patients With Extensive-Stage Small-Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Part A: Proportion of patients achieving an overall response (overall response rate) [ Time Frame: Date of enrollment to date of measured progressive disease ] [ Designated as safety issue: No ]
- Part B: Proportion of patients achieving a best response (clinical benefit rate) [ Time Frame: Date of enrollment to date of measured progressive disease ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: Date of enrollment to date of measured progressive disease or date of death from any cause ] [ Designated as safety issue: No ]
- Part A: Proportion of patients achieving a best response (clinical benefit rate) [ Time Frame: Date of enrollment to date of measured progressive disease ] [ Designated as safety issue: No ]
- Part B: Proportion of patients achieving an overall response (overall response rate) [ Time Frame: Date of enrollment to date of measured progressive disease ] [ Designated as safety issue: No ]
- Part A: Pharmacokinetics - Maximum Observed Drug Concentration [ Time Frame: Day 1,5,9 and 21 of cycle 1 ] [ Designated as safety issue: No ]
- Part B: Pharmacokinetics - Maximum Observed Drug Concentration [ Time Frame: Day 1,2,3,4 and 9 of cycle 1 ] [ Designated as safety issue: No ]
- Part A: Pharmacokinetics - Area Under the Curve [ Time Frame: Day 1,5,9 and 21 of cycle 1 ] [ Designated as safety issue: No ]
- Part B: Pharmacokinetics - Area Under the Curve [ Time Frame: Day 1,2,3,4 and 9 of cycle 1 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 88 |
| Study Start Date: | December 2009 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Part A LY2523355
8 mg/m2 per dose based on patient's body surface area, administered intravenously on Days 1, 5, 9 of each 21-day cycle, until disease progression or unacceptable toxicity.
|
Drug: LY2523355
Administered intravenously
|
|
Experimental: Part B LY2523355
5 mg/m2 per dose based on patient's body surface area, administered intravenously on Days 1, 2, 3 plus G-CSF support on each 21-day cycle, until disease progression or unacceptable toxicity.
|
Drug: LY2523355
Administered intravenously
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have histological or cytological evidence of extensive-disease small-cell lung cancer
- Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- Have received at least 1 prior chemotherapy regimen with agents known to provide clinical benefit for small-cell lung cancer and be, in the opinion of the investigator, an appropriate candidate for experimental therapy
- Have discontinued all previous therapies for cancer, including chemotherapy, biologic therapy, hormone therapy, or radiotherapy. Patients must have recovered from the acute effects of therapy (except alopecia and fatigue) before study enrollment
- Part A: Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group scale
- Part B: Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale
Exclusion Criteria:
- Have received treatment within 28 days of the first dose of LY2523355 with a drug that has not received regulatory approval for any indication
- Have a mixed histological diagnosis of small-cell lung cancer and non-small-cell lung cancer
- Have serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study
- Part A: Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and corticosteroid use has been discontinued for at least 2 weeks prior to the first dose of study drug. Screening of asymptomatic patients without history of CNS metastases is not required
- Part B: Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases or a history of CNS metastases. Patients who have received prophylactic radiation are not excluded. Screening of asymptomatic patients without history of CNS metastases is not required
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025284
Locations
| United States, Connecticut | |
| 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. | |
| Torrington, Connecticut, United States, 06790 | |
| 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. | |
| Athens, Georgia, United States, 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. | |
| Marietta, Georgia, United States, 30060 | |
| United States, Maine | |
| 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. | |
| Scarborough, Maine, United States, 04074 | |
| United States, New Jersey | |
| 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. | |
| Cherry Hill, New Jersey, United States, 08003 | |
| United States, New Mexico | |
| 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. | |
| Albuquerque, New Mexico, United States, 87131 | |
| 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. | |
| Memphis, Tennessee, United States, 38138 | |
| Korea, Republic of | |
| 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. | |
| Seoul, Korea, Republic of, 135-710 | |
| Romania | |
| 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. | |
| Bucharest, Romania, 022328 | |
| 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. | |
| Cluj-Napoca, Romania, 3400 | |
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 9AM-5PM Eastern time(UTC/GMT-5hours, EST) | Eli Lilly and Company |
More Information
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01025284 History of Changes |
| Other Study ID Numbers: | 12253, I1Y-MC-JFBD |
| Study First Received: | December 1, 2009 |
| Last Updated: | January 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013