A Study of Enzastaurin in Participants With Follicular Lymphoma
Status: | Completed |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/7/2018 |
Start Date: | May 2007 |
End Date: | December 2014 |
A Phase 2 Study of Enzastaurin in Participants With Follicular Lymphoma
To evaluate the antitumor activity, as measured by tumor response rate, of enzastaurin in
participants with Follicular Lymphoma (FL).
participants with Follicular Lymphoma (FL).
Inclusion Criteria:
All participants must:
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:
Participants will be excluded from the study if they meet any of the following 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.
We found this trial at
19
sites
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