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A Study for Patients With Relapsed Cutaneous T-Cell Lymphoma

This study is currently recruiting participants.
Verified by Eli Lilly and Company, October 2008

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00744991
  Purpose

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


Condition Intervention Phase
Cutaneous T-Cell Lymphoma
 Drug: Enzastaurin
 Phase II

MedlinePlus related topics:   Lymphoma   

Drug Information available for:   Enzastaurin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   A Phase 2, Open-Label, Multicenter Study of Single-Agent Enzastaurin in Patients With Relapsed Cutaneous T-Cell Lymphoma

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Response Rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   80
Study Start Date:   September 2008
Estimated Study Completion Date:   January 2013
Estimated Primary Completion Date:   January 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Arm A: Experimental
Enzastaurin, Open Label
Drug: Enzastaurin
1125 mg loading dose then 500 mg, oral, daily, until disease progression

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:
  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744991

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or     1-317-615-4559    

Locations
United States, Alabama
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.     Not yet recruiting
      Birmingham, Alabama, United States, 35233
      Contact: Eli Lilly            
United States, California
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.     Not yet recruiting
      Los Angeles, California, United States, 90095
      Contact: Eli Lilly            
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.     Not yet recruiting
      Stanford, California, United States, 94305
      Contact: Eli Lilly            
United States, Colorado
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.     Not yet recruiting
      Aurora, Colorado, United States, 80045
      Contact: Eli Lilly            
United States, Florida
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.     Not yet recruiting
      Miami, Florida, United States, 33136
      Contact: Eli Lilly            
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.     Not yet recruiting
      Orlando, Florida, United States, 32806
      Contact: Eli Lilly            
United States, Illinois
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.     Recruiting
      Chicago, Illinois, United States, 60611
      Contact: Eli Lilly            
United States, Indiana
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.     Not yet recruiting
      Indianapolis, Indiana, United States, 46202
      Contact: Eli Lilly            
United States, Massachusetts
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.     Not yet recruiting
      Boston, Massachusetts, United States, 02115
      Contact: Eli Lilly            
United States, Michigan
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.     Not yet recruiting
      Detroit, Michigan, United States, 48202
      Contact: Eli Lilly            
United States, Minnesota
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.     Not yet recruiting
      Minneapolis, Minnesota, United States, 55455
      Contact: Eli Lilly            
United States, Ohio
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.     Not yet recruiting
      Cleveland, Ohio, United States, 44195
      Contact: Eli Lilly            
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.     Not yet recruiting
      Columbus, Ohio, United States, 43210
      Contact: Eli Lilly            
United States, Oregon
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.     Not yet recruiting
      Portland, Oregon, United States, 97239
      Contact: Eli Lilly            
United States, Pennsylvania
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.     Not yet recruiting
      Pittsburgh, Pennsylvania, United States, 15213
      Contact: Eli Lilly            
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.     Recruiting
      Philadelphia, Pennsylvania, United States, 19104
      Contact: Eli Lilly            
United States, Tennessee
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.     Not yet recruiting
      Nashville, Tennessee, United States, 37232
      Contact: Eli Lilly            
United States, Texas
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.     Not yet recruiting
      Houston, Texas, United States, 77030
      Contact: Eli Lilly            

Sponsors and Collaborators
Eli Lilly and Company

Investigators
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    
  More Information


Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Eli Lilly ( Chief Medical Officer )
Study ID Numbers:   11496, H6Q-MC-JCCB
First Received:   August 29, 2008
Last Updated:   October 13, 2008
ClinicalTrials.gov Identifier:   NCT00744991
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Lymphatic Diseases
Mycoses
Sezary syndrome
Immunoproliferative Disorders
Cutaneous T-cell lymphoma
Lymphoma, T-Cell
Sezary Syndrome
Mycosis Fungoides
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on October 24, 2008

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