Trial of Enzastaurin and Bevacizumab in Adults With Recurrent Malignant Gliomas
This study is ongoing, but not recruiting participants.
Sponsor:
Eli Lilly and Company
Collaborator:
Genentech
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00586508
First received: December 7, 2007
Last updated: September 20, 2012
Last verified: September 2012
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Purpose
The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment recurrent malignant gliomas.
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Glioblastoma |
Drug: enzastaurin Drug: bevacizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Enzastaurin in Combination With Bevacizumab in Adults With Recurrent Malignant Gliomas |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Time to progressive disease [ Time Frame: baseline to disease progression ] [ Designated as safety issue: No ]
- Safety [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate tumor markers and genes [ Time Frame: baseline, every cycle ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: enzastaurin
1125 mg loading dose then 500 or 875 mg, oral, daily, 4 week cycles with patients evaluated after each cycle. The dose difference is for patients who are on enzyme-inducing antiepileptic drugs versus non-enzyme inducing antiepileptic drugs.
Other Name: LY317615
Drug: bevacizumab
10mg/kg, IV, every 2 weeks, patients are evaluated after each cycle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient must be at least 18 years old
- Patient must have been diagnosed with a recurrent brain tumor by MRI scan
- Patient must be willing to practice adequate contraception
- Patient must be able to swallow the Enzastaurin tablets whole and receive Bevacizumab intravenously
- Patient must agree to use the study drug only as instructed by your study doctor and staff.
Exclusion Criteria:
- Women who are pregnant or breastfeeding
- Patients who have significant heart, liver, kidney, or psychiatric disease
- Patients who have an active infection
- Patients who have any recent bleeding in the brain
- Patients who are taking any anti-coagulation or anti-platelet medication (including aspirin, non-steroidal anti-inflammatories, COX-2 inhibitors)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586508
Locations
| United States, Maryland | |
| 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. | |
| Bethesda, Maryland, United States | |
Sponsors and Collaborators
Eli Lilly and Company
Genentech
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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00586508 History of Changes |
| Obsolete Identifiers: | NCT00559923 |
| Other Study ID Numbers: | 11394, H6Q-MC-S033 |
| Study First Received: | December 7, 2007 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Glioblastoma Glioma Astrocytoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013