A Study for Participants With Relapsed Cutaneous T-Cell Lymphoma

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine the efficacy and safety of enzastaurin in participants with Cutaneous T-Cell Lymphoma (CTCL) who failed prior therapies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

Inclusion Criteria:

• Histologically confirmed mycosis fungoides or Sezary Syndrome.

• Stage IB to IVB disease at screening.

• Recurrent or refractory disease after at least 1 prior systemic therapy.

• Have adequate organ function defined as:

• Hepatic: total bilirubin ≤1.5 times the upper limit of normal (ULN); alanine transaminase/aspartate transaminase (ALT/AST) ≤2.5 times the ULN.

• Renal: serum creatinine ≤1.5 times the ULN.

• Adequate bone marrow reserve: platelets ≥75 * 10^9/Liters (L); absolute neutrophil count (ANC) ≥1.0 * 10^9/L.

• At least 30 days must have passed since other treatment for CTCL.

Exclusion Criteria:

• Receiving concurrent treatment for CTCL.

• Unable to swallow tablets.

• Receiving high potency oral or topical steroids. Low potency oral steroid may be permitted in participants who have been on a stable dose for at least 4 weeks prior to screening. Oral or topical antihistamine is allowed.

• Unable to discontinue use of carbamazepine, phenobarbital, or phenytoin.

• Have a serious concomitant systemic disorder or Human Immunodeficiency Virus (HIV).

• Have a serious cardiac condition such as myocardial infarction within past 6 months, angina, or heart disease as defined by the New York Heart Association (NYHA) Class III or IV.

• Have electrocardiogram (ECG) abnormalities.

• Are pregnant or breastfeeding.