A Study of Enzastaurin in Patients With Follicular Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00475644
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : April 3, 2015
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Lymphoma, Follicular Drug: enzastaurin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Enzastaurin in Patients With Follicular Lymphoma
Study Start Date : May 2007
Actual Primary Completion Date : April 2012
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Enzastaurin
enzastaurin: 1125 mg loading dose then 500 mg, oral daily, up to 3 years
Drug: enzastaurin
1125 mg loading dose then 500 mg, oral daily, up to 3 years
Other Name: LY317615

Primary Outcome Measures :
  1. Tumor response rate [ Time Frame: baseline to measured progressive disease ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: baseline to measured progressive disease ]
  2. Time to response [ Time Frame: baseline to date of confirmed response ]
  3. Duration of response [ Time Frame: time of response to progressive disease ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00475644

  Show 23 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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

Additional Information:
Responsible Party: Eli Lilly and Company Identifier: NCT00475644     History of Changes
Other Study ID Numbers: 8671
H6Q-MC-S011 ( Other Identifier: Eli Lilly and Company )
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin