Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

CEP-701 for PH-negative Myelofibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00494585
Recruitment Status : Completed
First Posted : June 29, 2007
Results First Posted : May 4, 2011
Last Update Posted : June 25, 2012
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Myelofibrosis
Intervention Drug: CEP-701
Enrollment 27
Recruitment Details Recruitment Period: 6/28/2007 through 10/25/2007. All participants recruited at UT MD Anderson Cancer Center.
Pre-assignment Details Of the 27 participants registered, 5 participants were ineligible to participate.
Arm/Group Title CEP-701
Hide Arm/Group Description 80 mg orally twice daily for 30 days
Period Title: Overall Study
Started 22
Completed 22
Not Completed 0
Arm/Group Title CEP-701
Hide Arm/Group Description 80 mg orally twice daily for 30 days
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants
61
(38 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
6
  27.3%
Male
16
  72.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
1.Primary Outcome
Title Number of Participants With Objective Response
Hide Description Objective response = Complete Response, absence sign/symptoms of disease (without use of growth factors, hydroxyurea, anagrelide, or transfusions for > 1 month); Partial Response, absence of progressive disease (PD), and improvement in 2+ parameters (if abnormal): Absolute neutrophil count (ANC), hemoglobin, platelets, transfusions, splenomegaly, or bone marrow blasts; Clinical Improvement, absence of PD, and improvement in 1 parameter: ANC, hemoglobin, platelets, transfusions, splenomegaly, or bone marrow blasts). [International Working Group on Myelofibrosis Research and Treatment]
Time Frame Response assessed after each 3 cycles (cycle = 30 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat.
Arm/Group Title CEP-701
Hide Arm/Group Description:
80 mg orally twice daily for 30 days
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: Participants
Complete Response (CR) 0
Partial Response (PR) 0
Clinical Improvement (CI) 6
Time Frame 3 years 10 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CEP-701
Hide Arm/Group Description 80 mg orally twice daily for 30 days
All-Cause Mortality
CEP-701
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CEP-701
Affected / at Risk (%) # Events
Total   7/22 (31.82%)    
Blood and lymphatic system disorders   
Hematoma  1 [1]  1/22 (4.55%)  1
Hemorrhage  1 [2]  1/22 (4.55%)  1
General disorders   
Debridement surgery with VAC placement  1 [3]  1/22 (4.55%)  1
Death  1 [4]  4/22 (18.18%)  4
Dehydration  1  1/22 (4.55%)  1
Infections and infestations   
Infection  1  1/22 (4.55%)  1
Respiratory, thoracic and mediastinal disorders   
Chronic Interstitial Pulmonary Fibrosis  1  1/22 (4.55%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Due to an accident
[2]
Due to a fall
[3]
After an accidental fall
[4]
Disease Progression
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CEP-701
Affected / at Risk (%) # Events
Total   19/22 (86.36%)    
Blood and lymphatic system disorders   
Anemia  1  6/22 (27.27%)  6
Thrombocytopenia  1  5/22 (22.73%)  5
Gastrointestinal disorders   
Diarrhea  1  16/22 (72.73%)  16
Nausea  1  11/22 (50.00%)  11
Vomiting  1  6/22 (27.27%)  6
Flatulence  1  5/22 (22.73%)  5
Heartburn  1  4/22 (18.18%)  4
Mucositis  1  3/22 (13.64%)  3
Anorexia  1  2/22 (9.09%)  2
General disorders   
Fatigue  1  2/22 (9.09%)  2
Hepatobiliary disorders   
Elevated aspartate aminotransferase  1  6/22 (27.27%)  6
Elevated alanine aminotransferase  1  6/22 (27.27%)  6
Elevated alkaline phosphatase  1  2/22 (9.09%)  2
Hyperbilirubinemia  1  2/22 (9.09%)  2
Nervous system disorders   
Headache  1  7/22 (31.82%)  7
Peripheral Neuropathy  1  3/22 (13.64%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Srdan Verstovsek M.D./Associate Professor
Organization: The University of Texas M. D. Anderson Cancer Center
Phone: 713-792-7305
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00494585     History of Changes
Other Study ID Numbers: 2007-0070
CS-2007-20040
First Submitted: June 28, 2007
First Posted: June 29, 2007
Results First Submitted: April 7, 2011
Results First Posted: May 4, 2011
Last Update Posted: June 25, 2012