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A Phase 2 Study of LY2523355 in Patients With Extensive-Stage Small-Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Small Cell Lung Cancer

Thank you

Trial Information

A Phase 2 Study of LY2523355 in Patients With Extensive-Stage Small-Cell Lung Cancer


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Part A: Proportion of patients achieving an overall response (overall response rate)

Outcome Time Frame:

Date of enrollment to date of measured progressive disease

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

12253

NCT ID:

NCT01025284

Start Date:

December 2009

Completion Date:

July 2012

Related Keywords:

  • Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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.Stamford, Connecticut  06902
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.Cherry Hill, New Jersey  08003
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.Scarborough, Maine  04074
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  87106