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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00530621
First received: September 13, 2007
Last updated: October 16, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
Drug: enzastaurin
Drug: placebo
Drug: pemetrexed
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Time to worsening of symptoms [ Time Frame: baseline to disease worsening ] [ Designated as safety issue: No ]
  • Duration of disease control [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Enrollment: 149
Study Start Date: September 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  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: NCT00530621

  Show 25 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

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00530621     History of Changes
Other Study ID Numbers: 9820, H6Q-MC-JCBT
Study First Received: September 13, 2007
Last Updated: October 16, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014