A Study for Patients With Relapsed Cutaneous T-Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00744991
First received: August 29, 2008
Last updated: October 25, 2010
Last verified: October 2010

August 29, 2008
October 25, 2010
September 2008
January 2010   (final data collection date for primary outcome measure)
Response Rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00744991 on ClinicalTrials.gov Archive Site
  • Duration of response for responding patients [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Time to objective response for responding patients [ Time Frame: baseline to confirmed response ] [ Designated as safety issue: No ]
  • Patient-reported measures of health-state utility and pruritus [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of enzastaurin in this patient population [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study for Patients With Relapsed Cutaneous T-Cell Lymphoma
A Phase 2, Open-Label, Multicenter Study of Single-Agent Enzastaurin in Patients With Relapsed Cutaneous T-Cell Lymphoma

The purpose of the study is to determine the efficacy and safety of enzastaurin in patients with CTCL who failed prior therapies.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cutaneous T-Cell Lymphoma
Drug: Enzastaurin
1125 mg loading dose then 500 mg, oral, daily, until disease progression
Other Name: LY317615
Experimental: Arm A
Enzastaurin, Open Label
Intervention: Drug: Enzastaurin
Querfeld C, Kuzel TM, Kim YH, Porcu P, Duvic M, Musiek A, Rook AH, Mark LA, Pinter-Brown L, Hamid O, Lin B, Bian Y, Boye M, Day JM, Rosen ST. Multicenter phase II trial of enzastaurin in patients with relapsed or refractory advanced cutaneous T-cell lymphoma. Leuk Lymphoma. 2011 Aug;52(8):1474-80. doi: 10.3109/10428194.2011.572265. Epub 2011 Jun 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
February 2010
January 2010   (final data collection date for primary outcome measure)

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:
  • 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 patients 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 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 ECG abnormalities,
  • Are pregnant or breastfeeding
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00744991
11496, H6Q-MC-JCCB
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP