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A Randomized Phase 2 Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Were Previously Treated With First Line Chemotherapy


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

Thank you

Trial Information

A Randomized Phase 2 Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Were Previously Treated With First Line Chemotherapy


Inclusion Criteria:



- Patients with non-small cell lung cancer with locally or advanced metastatic
disease(Stage IIIB or IV at entry) not amenable to curative therapy and who have
progressed after 1 line of chemotherapy

- Measureable disease as defined by response evaluation criteria in solid tumors
(RECIST)

- ECOG Performance status of 0 to 1

- Must make available any existing tumor tissue from the primary biopsy

- Patients with prior radiation may be eligible if they meet certain criteria

- Adequate bone marrow reserve and organ functioning

- Women must have a negative pregnancy test and must comply with a highly reliable
contraceptive method during and for 6 months after the treatment period. Must not be
breastfeeding

- Men must comply with a contraceptive regimen during and for 6 months after the
treatment period

Exclusion Criteria:

- Currently enrolled in or discontinued a clinical trial involving an investigational
drug/device within the last 30 days. Patients may be permitted to enter treatment
before the 30 day waiting period in special circumstances

- Pregnant or breastfeeding

- Serious concomitant systemic disorders that would compromise the safety of the
patient or the patient's ability to complete the study

- Second primary malignancy that could affect compliance with the protocol or
interpretation of the study results

- Known allergy or hypersensitivity to docetaxel, taxanes, LY2181308, oligonucleotides,
or any component of the formulations

- Patients with documented central nervous system or brain metastasis at the time of
study entry

- Pre-existing neuropathy equivalent to a common terminology criteria for adverse
events(CTCAE)code greater than or equal to 2

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in tumor size from baseline to end of cycle 2

Outcome Time Frame:

Baseline, end of cycle 2

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

11766

NCT ID:

NCT01107444

Start Date:

May 2010

Completion Date:

June 2012

Related Keywords:

  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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. Manhassaet, New York  
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. Greenbrae, California  94904
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  32256
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. Chicago, Illinois  60674
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. Kalamazoo, Michigan  49048
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. Minneapolis, Minnesota  55404
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. Portsmouth, New Hampshire  03801
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. Marshfield, Wisconsin  54449