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Trial record 37 of 225 for:    "essential thrombocythemia"

Study to Assess the Safety of AZD1480 in Patients With Myeloproliferative Diseases

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ClinicalTrials.gov Identifier: NCT00910728
Recruitment Status : Completed
First Posted : June 1, 2009
Results First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Sponsor:
Collaborators:
University of Texas
New York City Hoffman Center
Gustave Roussy, Cancer Campus, Grand Paris
Information provided by (Responsible Party):
AstraZeneca

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions: Primary Myelofibrosis (PMF)
Post-Polycythaemia Vera
Essential Thrombocythaemia Myelofibrosis
Intervention: Drug: AZD1480

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Commenced 19MAY2009. All subjects recruited to Part A only (based on emerging data). 65 patients were enrolled of which 35 recieved at least 1 dose of AZD1480.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients ≥25 years of age with primary myelofibrosis (MF) and post-polycythaemia vera/essential thrombocythaemia MF who had relapsed, were intolerant of, or were refractory to MF-directed therapy were enrolled.

Reporting Groups
  Description
2.5 mg QD AZD1480 may be administered orally in capsules
5.0 mg QD AZD1480 may be administered orally in capsules
10 mg QD AZD1480 may be administered orally in capsules
30 mg QD AZD1480 may be administered orally in capsules
50 mg QD AZD1480 may be administered orally in capsules
70 mg QD AZD1480 may be administered orally in capsules
10 mg BID AZD1480 may be administered orally in capsules
15 mg BID AZD1480 may be administered orally in capsules
20 mg QD AZD1480 may be administered orally in capsules

Participant Flow:   Overall Study
    2.5 mg QD   5.0 mg QD   10 mg QD   30 mg QD   50 mg QD   70 mg QD   10 mg BID   15 mg BID   20 mg QD
STARTED   6   3   3   3   6   1   6   4   3 
COMPLETED   0   0   0   0   1   0   0   1   0 
NOT COMPLETED   6   3   3   3   5   1   6   3   3 
Lack of Efficacy                2                3                1                2                1                0                2                2                2 
Withdrawal by Subject                0                0                0                0                3                1                2                0                0 
(not specified)                2                0                1                0                1                0                0                0                0 
Adverse Event                2                0                1                1                0                0                2                1                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
2.5 mg QD AZD1480 may be administered orally in capsules
5.0 mg QD AZD1480 may be administered orally in capsules
10 mg QD AZD1480 may be administered orally in capsules
70 mg QD AZD1480 may be administered orally in capsules
15 mg BID AZD1480 may be administered orally in capsules
30 mg QD AZD1480 may be administered orally in capsules
50 mg QD AZD1480 may be administered orally in capsules
10 mg BID AZD1480 may be administered orally in capsules
20 mg QD AZD1480 may be administered orally in capsules
Total Total of all reporting groups

Baseline Measures
   2.5 mg QD   5.0 mg QD   10 mg QD   70 mg QD   15 mg BID   30 mg QD   50 mg QD   10 mg BID   20 mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   3   3   1   4   3   6   6   3   35 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.5  (7.7)   66.3  (9.6)   76.7  (10.5)   56.0  (0)   66.5  (10.3)   49.3  (4.2)   69.3  (3.8)   65.3  (11.3)   75.7  (3.8)   65.1  (10.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                   
Female      1  16.7%      1  33.3%      1  33.3%      1 100.0%      0   0.0%      1  33.3%      5  83.3%      2  33.3%      2  66.7%      14  40.0% 
Male      5  83.3%      2  66.7%      2  66.7%      0   0.0%      4 100.0%      2  66.7%      1  16.7%      4  66.7%      1  33.3%      21  60.0% 


  Outcome Measures

1.  Primary:   Pharmacokinetic Parameters Following Single Dosing: AUC0-12   [ Time Frame: 0 to 12 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post dose) ]

2.  Primary:   Pharmacokinetic Parameters Following Single Dosing: AUC0-24   [ Time Frame: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose) ]

3.  Primary:   Pharmacokinetic Parameters Following Single Dosing:AUC0-inf   [ Time Frame: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose) ]

4.  Primary:   Pharmacokinetic Parameters Following Multiple Dosing: Cmax,ss   [ Time Frame: On Days 1 and 28 at 0, 0,5, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose, and at 0, 2, 4 hours post dose on Days 4 and 10 ]

5.  Primary:   Pharmacokinetic Parameters Following Multiple Dosing: Cmin,ss   [ Time Frame: On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose and at 0, 2, 4 hours post-dose on Days 4 and 10. ]

6.  Primary:   Pharmacokinetic Parameters Following Single Dosing: Cmax   [ Time Frame: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose) ]

7.  Primary:   Pharmacokinetic Parameters Following Single Dosing: Vz/F   [ Time Frame: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose) ]

8.  Primary:   Pharmacokinetic Parameters Following Single Dosing: CL/F   [ Time Frame: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose) ]

9.  Primary:   Pharmacokinetic Parameters Following Multiple Dosing: CLss/F   [ Time Frame: On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dose ]

10.  Primary:   Pharamcokinetic Parameters Following Single Dosing: Tmax   [ Time Frame: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose) ]

11.  Primary:   Pharamcokinetic Parameters Following Multiple Dosing: Tmax,ss   [ Time Frame: On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dose on Days 4 and 10 ]

12.  Primary:   Inhibition of PSTAT3 (Count)   [ Time Frame: 2hrs and 4 hrs post dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr Gregory Curt, MD
Organization: AstraZeneca
phone: +1 301 398 0109
e-mail: Gregory.Curt@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00910728     History of Changes
Other Study ID Numbers: D1060C00001
First Submitted: May 28, 2009
First Posted: June 1, 2009
Results First Submitted: August 18, 2015
Results First Posted: April 24, 2017
Last Update Posted: April 24, 2017