Glioblastoma Clinical Trial
Official title:
Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma
| Verified date | September 2019 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).
| Status | Completed |
| Enrollment | 397 |
| Est. completion date | May 2014 |
| Est. primary completion date | August 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Patient presents with histologically confirmed diagnosis of brain cancer (specifically glioblastoma multiforme). 2. Your cancer has returned following therapy. 3. Patient may have undergone prior surgery to remove cancer. 4. Patient must be able to care for self. Exclusion Criteria: 1. 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. 2. 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. 3. Patients receiving medication for seizures must discontinue 14 days prior to enrolling. 4. Cannot be on blood thinning medication at study enrollment. 5. Cannot be on other medicines to prevent cancer at study enrollment. 6. Patients are not allowed to enter the study if they have previously taken Enzastaurin, Lomustine and/or Bevacizumab. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Auchenflower | Queensland |
| Australia | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Heidelberg | Victoria |
| Australia | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Liverpool | New South Wales |
| Australia | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nedlands | Western Australia |
| Australia | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | St Leonards | New South Wales |
| Austria | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Graz | |
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| Netherlands | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Amsterdam | |
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| Poland | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lublin | |
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| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Australia, Austria, Belgium, Canada, France, Germany, India, Italy, Mexico, Netherlands, Poland, Spain, United Kingdom,
Wick W, Puduvalli VK, Chamberlain MC, van den Bent MJ, Carpentier AF, Cher LM, Mason W, Weller M, Hong S, Musib L, Liepa AM, Thornton DE, Fine HA. Phase III study of enzastaurin compared with lomustine in the treatment of recurrent intracranial glioblasto — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | baseline to measured progressive disease (PD) | ||
| Secondary | To measure survival to see how the tumor responded to the therapy and how long the response lasted using MRI (a scanning technique). | time of response to progressive disease | ||
| Secondary | To measure changes in patient's ability to care for themselves (this will be determined through a standard survey). | over entire study | ||
| Secondary | To measure changes from baseline and a neurologic exam. | baseline, each cycle | ||
| Secondary | To review all bad reactions reported by the patient and detected in blood tests. | each cycle | ||
| Secondary | To review the effect of the cancer on the patient's ability to care for themselves and on their general health status. | over entire study | ||
| Secondary | To determine through blood tests how long the medication is in the patient's body. | cycle 1, cycle 4 | ||
| Secondary | 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. | baseline, cycle 2, end of study |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05664243 -
A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma
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Phase 1/Phase 2 | |
| Completed |
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Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma
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Early Phase 1 | |
| Recruiting |
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Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma
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Phase 1/Phase 2 | |
| Completed |
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Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102
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Phase 1 | |
| Completed |
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Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma
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Phase 1 | |
| Terminated |
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Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma
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Phase 2 | |
| Recruiting |
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PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma
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Phase 2 | |
| Active, not recruiting |
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OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma
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Phase 1 | |
| Completed |
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Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas
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Phase 1 | |
| Recruiting |
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Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma
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Phase 2 | |
| Active, not recruiting |
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Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma
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Phase 2 | |
| Active, not recruiting |
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Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001
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Phase 2 | |
| Completed |
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Trial of Hypofractionated Radiation Therapy for Glioblastoma
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Phase 2 | |
| Completed |
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Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade
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Phase 1 | |
| Terminated |
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Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
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Phase 1/Phase 2 | |
| Recruiting |
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Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
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Phase 2 | |
| Completed |
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Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)
|
Phase 2 | |
| Withdrawn |
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Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells
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Early Phase 1 | |
| Not yet recruiting |
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A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma
|
Phase 2 | |
| Terminated |
NCT02905643 -
Discerning Pseudoprogression vs True Tumor Growth in GBMs
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