Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01107444
First received: April 15, 2010
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to evaluate the anti-tumor activity of LY2181308 in combination with docetaxel compared to docetaxel alone in patients with non-small cell lung cancer who were previously treated with first line chemotherapy.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Docetaxel
Drug: LY2181308
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change in tumor size from baseline to end of cycle 2 [ Time Frame: Baseline, end of cycle 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterization of toxicities as defined by common terminology criteria for adverse events (CTCAE) coding [ Time Frame: Every cycle, 30 day follow up and long term follow up (every 6 weeks until progression then every 60 days for survival or until study ends) ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: Randomization to the first date of progressive disease or death from any cause ] [ Designated as safety issue: No ]
  • Population Pharmacokinetics,including concentration of LY2181308 and docetaxel [ Time Frame: Lead in phase, Cycle 1, Cycle 2 then every other Cycle, 30 day follow up visit ] [ Designated as safety issue: No ]
    Exposures as determined by AUC will be correlated with response across the study

  • Overall Survival [ Time Frame: Randomization to date of death from any cause ] [ Designated as safety issue: No ]
  • Time to worsening of symptoms as defined by Lung Cancer Symptom Score (LCSS) questionnaire [ Time Frame: Baseline to the worsening of symptoms (30 day follow up) ] [ Designated as safety issue: No ]
  • Time of Objective tumor response of Partial Response (PR) or Complete Response (CR) [ Time Frame: Randomization to the date of first response ] [ Designated as safety issue: No ]
  • Time to documented disease progression [ Time Frame: Randomization to the first date of progressive disease ] [ Designated as safety issue: No ]
  • Percent of patients having a Partial Response (PR) or a Complete Response (CR) [ Time Frame: Randomization to the first date of progressive disease ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: Time of response to progressive disease ] [ Designated as safety issue: No ]
  • Change from baseline through 30 day follow up in Average Symptom Burden Index (ASBI) [ Time Frame: Baseline, 30 day follow up ] [ Designated as safety issue: No ]
  • Change from baseline through 30 day follow up in Lung Cancer Symptom Scale (LCSS) [ Time Frame: Baseline, 30 day follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2010
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2181308 + Docetaxel

Lead in Phase:

Day -2 and Day -1 of a 2 day lead-in period: LY2181308 750 mg

Cycle 1 (cycle = 21 days)

Day 1, Day 6, Day 14: LY2181308 750 mg, Day 1: docetaxel 75mg/m2

Cycles 2-6 (cycle = 21 days):

Day 1 through 21: LY2181308 750 mg once weekly, Day 1: Docetaxel 75mg/m2

After 6 cycles, it may be possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.

Drug: Docetaxel
Administered intravenously
Drug: LY2181308
Administered intravenously
Active Comparator: Docetaxel

Cycles 1-6 (Cycle = 21 days):

Day 1: Docetaxel 75 mg/m2

After 6 cycles, it may be possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.

Drug: Docetaxel
Administered intravenously

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01107444

  Show 36 Study Locations
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 - 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: NCT01107444     History of Changes
Other Study ID Numbers: 11766, H8Z-MC-JACW, 2009-017591-24
Study First Received: April 15, 2010
Last Updated: August 9, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014