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CEP-701 for PH-negative Myelofibrosis

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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
Layout table for Results Point of Contact information
Name/Title: Srdan Verstovsek M.D./Associate Professor
Organization: The University of Texas M. D. Anderson Cancer Center
Phone: 713-792-7305
EMail: eharriso@mdanderson.org
Layout table for additonal information
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