Overview

This trial is active, not recruiting.

Condition lymphoma, follicular
Treatment enzastaurin
Phase phase 2
Sponsor Eli Lilly and Company
Start date May 2007
End date April 2010
Trial size 60 participants
Trial identifier NCT00475644, 8671, H6Q-MC-S011

Summary

To evaluate the antitumor activity, as measured by tumor response rate, of enzastaurin in patients with Follicular Lymphoma (FL).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
enzastaurin: 1125 mg loading dose then 500 mg, oral daily, up to 3 years
enzastaurin LY317615
1125 mg loading dose then 500 mg, oral daily, up to 3 years

Primary Outcomes

Measure
Tumor response rate
time frame: baseline to measured progressive disease

Secondary Outcomes

Measure
Progression-free survival
time frame: baseline to measured progressive disease
Time to response
time frame: baseline to date of confirmed response
Duration of response
time frame: time of response to progressive disease

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: All patient 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. Patients 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. Patients 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: Patients 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 patient's ability to adhere to the protocol.

Additional Information

Official title A Phase 2 Study of Enzastaurin in Patients With Follicular Lymphoma
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.