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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00530621 |
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Date of registration:
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13/09/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Enzastaurin Versus Placebo With Pemetrexed for Participants With Advanced or Metastatic Lung Cancer
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Scientific title:
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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 |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00530621 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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France
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Germany
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Italy
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Korea, Republic of
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Portugal
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United States
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Contacts
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Name:
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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 |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Laboratory confirmed diagnosis of NSCLC with locally advanced or metastatic disease
which cannot be cured.
- Participants 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non-small Cell Lung Cancer
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Intervention(s)
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Drug: enzastaurin
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Drug: pemetrexed
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Drug: placebo
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Primary Outcome(s)
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Progression-Free Survival (PFS)
[Time Frame: Baseline to measured progressive disease up to 9.92 months]
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Secondary Outcome(s)
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Percentage of Participants With Complete Response or Partial Response (Tumor Response Rate)
[Time Frame: Baseline to measured progressive disease up to 9.92 months]
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Duration of Disease Control (DDC)
[Time Frame: Baseline to measured progressive disease up to 9.92 months]
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Overall Survival (OS)
[Time Frame: Baseline to date of death from any cause up to 12.32 months]
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Time-to-Worsening (TW) in Lung Cancer Symptom Scale (LCSS) - Health Related Quality of Life (HRQoL) Subscale
[Time Frame: Baseline to disease worsening up to 10.58 months]
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Tumor Biomarkers
[Time Frame: Tumor samples collected at baseline]
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Secondary ID(s)
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H6Q-MC-JCBT
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9820
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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