A Study of Enzastaurin in Participants With Follicular Lymphoma
NCT ID: NCT00475644
Last Updated: 2018-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2007-05-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Enzastaurin
Enzastaurin: 1125 milligram (mg) loading dose then 500 mg, oral daily, up to 3 years
Enzastaurin
Administered orally
Interventions
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Enzastaurin
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Have had a histologically confirmed diagnosis of Grade 1 or 2 FL, according to World Health Organization classification (Harris et al. 1999), at the original time of diagnosis. Pathology must be confirmed locally prior to enrollment at the investigational site.
2. Have Ann Arbor Stage III or IV disease.
3. Must be chemo-naive OR have relapsed disease after receiving only one prior chemotherapy regimen. The chemotherapy must have been completed at least 6 months prior to first dose of study treatment. Relapse after one prior course of single-agent rituximab treatment (in the chemo-naive setting) is also allowed if completed at least 6 months prior to first dose of study treatment.
4. Participants must not require cytoreductive therapy for at least 3 months from first dose of study treatment, in the opinion of the investigator.
5. Previous radiation therapy is allowed, but should have been limited and must not have included whole pelvis radiation. Participants must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry. Lesions that have been irradiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
Exclusion Criteria
1. Are unable to swallow tablets.
2. Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
3. Are receiving concurrent administration of any other antitumor therapy.
4. Are pregnant or breastfeeding.
5. Have a serious concomitant systemic disorder (including active bacterial, fungal, or viral infection) that, in the opinion of the investigator, would compromise the participant's ability to adhere to the protocol.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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.
Casa Grande, Arizona, United States
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.
La Verne, California, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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Fort Myers, Florida, United States
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Augusta, Georgia, United States
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Marietta, Georgia, United States
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Coeur d'Alene, Idaho, United States
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Lafayette, Indiana, United States
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Billings, Montana, United States
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Cincinnati, Ohio, United States
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Lawton, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Richmond, Virginia, United States
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La Crosse, Wisconsin, United States
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Berlin, , Germany
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Bielefeld, , Germany
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Hamburg, , Germany
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Kiel, , Germany
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Munich, , Germany
Countries
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Other Identifiers
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H6Q-MC-S011
Identifier Type: OTHER
Identifier Source: secondary_id
8671
Identifier Type: -
Identifier Source: org_study_id
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