| February 22, 2006 |
| September 18, 2008 |
| March 2006 |
| November 2008 (final data collection date for primary outcome measure) |
| The primary objective is to compare Enzastaurin versus Lomustine in patients who for the second time have brain cancer (specifically intracranial glioblastoma) to see what effect the drugs have on keeping the disease from progressing (worsening). [ Time Frame: baseline to measured progressive disease (PD) ] [ Designated as safety issue: No ] |
| The primary objective is to compare Enzastaurin versus Lomustine in patients who for the second time have brain cancer (specifically intracranial glioblastoma) to see what effect the drugs have on keeping the disease from progressing (worsening). |
| Complete list of historical versions of study NCT00295815 on ClinicalTrials.gov Archive Site |
- To measure survival to see how the tumor responded to the therapy and how long the response lasted using MRI (a scanning technique). [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
- To measure changes in patient's ability to care for themselves (this will be determined through a standard survey). [ Time Frame: over entire study ] [ Designated as safety issue: No ]
- To measure changes from baseline and a neurologic exam. [ Time Frame: baseline, each cycle ] [ Designated as safety issue: Yes ]
- To review all bad reactions reported by the patient and detected in blood tests. [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]
- To review the effect of the cancer on the patient's ability to care for themselves and on their general health status. [ Time Frame: over entire study ] [ Designated as safety issue: No ]
- To determine through blood tests how long the medication is in the patient's body. [ Time Frame: cycle 1, cycle 4 ] [ Designated as safety issue: No ]
- To review through testing of tumor and blood samples to see if there are reasons why some patients responded to the drugs better than other patients. [ Time Frame: baseline, cycle 2, end of study ] [ Designated as safety issue: No ]
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- To measure survival to see how the tumor responded to the therapy and how long the response lasted using MRI (a scanning technique).
- To measure changes in patient's ability to care for themselves (this will be determined through a standard survey).
- To measure changes from baseline and a neurologic exam.
- To review all bad reactions reported by the patient and detected in blood tests.
- To review the effect of the cancer on the patient's ability to care for themselves and on their general health status.
- To determine through blood tests how long the medication is in the patient's body.
- To review through testing of tumor and blood samples to see if there are reasons why some patients responded to the drugs better than other patients.
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| Enzastaurin Versus Lomustine in Glioblastoma |
| Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma |
This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme). |
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| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Glioblastoma |
- Drug: enzastaurin
- Drug: lomustine
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| |
| Active, not recruiting |
| 397 |
| November 2008 |
| November 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Patient presents with histologically confirmed diagnosis of brain cancer (specifically glioblastoma multiforme).
- Your cancer has returned following therapy.
- Patient may have undergone prior surgery to remove cancer.
- Patient must be able to care for self.
Exclusion Criteria:
- Have a second type of cancer (except adequately treated basal cell carcinoma of the skin). Patient who has had another cancer in the past, must be free of cancer for more than 2 years.
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of entry.
- Patients receiving medication for seizures must discontinue 14 days prior to enrolling.
- Cannot be on blood thinning medication at study enrollment.
- Cannot be on other medicines to prevent cancer at study enrollment.
- Patients are not allowed to enter the study if they have previously taken Enzastaurin, Lomustine and/or Bevacizumab.
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Australia, Austria, Belgium, Canada, France, Germany, India, Italy, Mexico, Netherlands, Poland, Spain, United Kingdom |
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| NCT00295815 |
| Chief Medical Officer, Eli Lilly |
| 9817, H6Q-MC-JCBF |
| Eli Lilly and Company |
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| Study Director: |
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) |
Eli Lilly and Company |
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| Eli Lilly and Company |
| September 2008 |