Status:
COMPLETED
A Study for Participants With Relapsed Cutaneous T-Cell Lymphoma
Lead Sponsor:
Eli Lilly and Company
Conditions:
Cutaneous T-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00744991
Start Date
September 1 2008
End Date
February 1 2010
Last Update
October 19 2020
Active Locations (16)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Birmingham, Alabama, United States, 35233
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Angeles, California, United States, 90095
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Stanford, California, United States, 94305
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aurora, Colorado, United States, 80045