Study of Enzastaurin Versus Placebo With Pemetrexed for Patients With Advanced or Metastatic Lung Cancer
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| ClinicalTrials.gov Identifier: NCT00530621 |
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Recruitment Status :
Completed
First Posted : September 17, 2007
Last Update Posted : October 19, 2009
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Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
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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 |
| Actual Primary Completion Date : | October 2008 |
| Actual Study Completion Date : | October 2008 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
| 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:
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| 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:
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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 ]
Secondary Outcome Measures :
- Overall survival [ Time Frame: baseline to date of death from any cause ]
- Time to worsening of symptoms [ Time Frame: baseline to disease worsening ]
- Duration of disease control [ Time Frame: baseline to measured progressive disease ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
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
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 |
Additional Information:
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00530621 History of Changes |
| Other Study ID Numbers: |
9820 H6Q-MC-JCBT |
| First Posted: | September 17, 2007 Key Record Dates |
| Last Update Posted: | October 19, 2009 |
| Last Verified: | October 2009 |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |