A Study for Participants With Relapsed Cutaneous T-Cell Lymphoma

Lilly

Status and phase

Completed

Phase 2

Conditions

Cutaneous T-Cell Lymphoma

Treatments

Drug: Enzastaurin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00744991

H6Q-MC-JCCB (Other Identifier)

11496

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.