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Study of Enzastaurin Versus Placebo With Pemetrexed for Patients With Advanced or Metastatic Lung Cancer

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ClinicalTrials.gov Identifier: NCT00530621
Recruitment Status : Completed
First Posted : September 17, 2007
Last Update Posted : October 19, 2009
Information provided by:
Eli Lilly and Company

Brief Summary:
The purpose of this study is to determine if the combination of enzastaurin and pemetrexed can extend survival time without progression of disease for patients who have advanced or metastatic non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: enzastaurin Drug: placebo Drug: pemetrexed Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Double-Blind Randomized Study of Oral Enzastaurin HCl Versus Placebo Concurrently With Pemetrexed (Alimta®) as Second-Line Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Study Start Date : September 2007
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily Cycle 1 (28 days), subsequent cycles 21 days, until disease progression
Other Name: LY317615
Drug: pemetrexed
500 mg/m2, IV, day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression
Other Names:
  • LY231514
  • Alimta
Placebo Comparator: B Drug: placebo
oral, daily
Drug: pemetrexed
500 mg/m2, IV, day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression
Other Names:
  • LY231514
  • Alimta

Primary Outcome Measures :
  1. To compare pemetrexed plus enzastaurin versus pemetrexed plus placebo in terms of the progression-free survival time (PFS) of patients receiving second-line therapy for the treatment of locally advanced or metastatic NSCLC. [ Time Frame: baseline to measured progressive disease ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: baseline to date of death from any cause ]
  2. Time to worsening of symptoms [ Time Frame: baseline to disease worsening ]
  3. Duration of disease control [ Time Frame: baseline to measured progressive disease ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Laboratory confirmed diagnosis of NSCLC with locally advanced or metastatic disease which cannot be cured.
  • Patients must have disease which progressed after 1 prior systemic cytotoxic chemotherapy regimen for advanced disease.
  • At least 1 measurable lesion.
  • Must have stopped all previous systemic therapies for cancer for at least 2 weeks prior to enrollment.
  • Must be able to follow study guidelines and be able to show up for appointments.

Exclusion Criteria:

  • Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Previous treatment with enzastaurin or pemetrexed.
  • Concurrent administration of any other antitumor therapy.
  • Inability to swallow tablets
  • Pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530621

  Show 25 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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

Additional Information:
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00530621     History of Changes
Other Study ID Numbers: 9820
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: October 19, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors