A Study for Patients With Small-Cell Lung Cancer

This study has been completed.
Sponsor:
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
  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
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: 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 July 22, 2014