Study of Enzastaurin Versus Placebo With Pemetrexed for Patients With Advanced or Metastatic Lung Cancer - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00530621

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 II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Pemetrexed disodium Pemetrexed Enzastaurin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
A: Active Comparator	Drug: enzastaurin 1125 mg loading dose then 500 mg, oral, daily Cycle 1 (28 days), subsequent cycles 21 days, until disease progression Drug: pemetrexed 500 mg/m2, IV, day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression
B: Placebo Comparator	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

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

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

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	9820, H6Q-MC-JCBT
Study First Received:	September 13, 2007
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00530621
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Folic Acid
Pemetrexed
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009