Enzastaurin Versus Lomustine in Glioblastoma
This study is ongoing, but not recruiting participants.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00295815
First received: February 22, 2006
Last updated: May 23, 2013
Last verified: May 2013
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Purpose
This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma |
Drug: enzastaurin Drug: lomustine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 397 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | November 2013 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, 6 week cycles until PD
Other Name: LY317615
|
| Active Comparator: B |
Drug: lomustine
100-130 mg/m2, oral once, every 6 weeks until PD
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295815
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| Guadalajara, Mexico, 44280 | |
| 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. | |
| Mexico City, Mexico, 11640 | |
| 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. | |
| Monterrey, Mexico, 64060 | |
| 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. | |
| Tijuana, Mexico, 22329 | |
| 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. | |
| Tlalpan, Mexico, 14269 | |
| 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. | |
| Toluca, Mexico, 52140 | |
| 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, Netherlands, 1105 AZ | |
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| Den Haag, Netherlands, 2512 VA | |
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| Maastricht, Netherlands, 6229 HX | |
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| Rotterdam, Netherlands, 3075 EA | |
| Poland | |
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| Lublin, Poland, 20-950 | |
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| Warsaw, Poland, 02-781 | |
| Spain | |
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| Badalona, Spain, 08915 | |
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| Hospitalet Llobregat, Spain, 08907 | |
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| Madrid, Spain, 28040 | |
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| Oviedo, Spain, 33006 | |
| 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. | |
| Valencia, Spain, 46014 | |
| United Kingdom | |
| 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. | |
| Bristol, Avon, United Kingdom, BS2 8ED | |
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| Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ | |
| 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. | |
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |
| 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. | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
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 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00295815 History of Changes |
| Other Study ID Numbers: | 9817, H6Q-MC-JCBF |
| Study First Received: | February 22, 2006 |
| Last Updated: | May 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Lomustine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013