Trial Outcomes & Findings for Ph II Study of Azacitidine in Myelofibrosis (NCT NCT00569660)
NCT ID: NCT00569660
Last Updated: 2012-08-07
Results Overview
Objective Clinical Response includes Participants with Complete Response, Partial Response or Hematologic Improvement and No Response. Bone marrow aspiration and biopsy with cytogenetics every 2 to 4 courses.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Every 2 courses of 4 week therapy = each 8 weeks
Results posted on
2012-08-07
Participant Flow
Recruitment Period 6/7/05 to 4/4/08. All patients registered at The University of Texas M.D. Anderson Cancer Center.
The maximum accrual of 34 was met.
Participant milestones
| Measure |
Azacitidine
75 mg/m\^2 Subcutaneous daily for 7 days every 4 weeks
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ph II Study of Azacitidine in Myelofibrosis
Baseline characteristics by cohort
| Measure |
Azacitidine
n=34 Participants
75 mg/m\^2 Subcutaneous daily for 7 days every 4 weeks
|
|---|---|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
|
Age Continuous
|
67 years
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 2 courses of 4 week therapy = each 8 weeksPopulation: The statistical analysis for response rates determined on the intent-to-treat (ITT) populations. This is defined as all enrolled patients who received at least one dose of study medication.
Objective Clinical Response includes Participants with Complete Response, Partial Response or Hematologic Improvement and No Response. Bone marrow aspiration and biopsy with cytogenetics every 2 to 4 courses.
Outcome measures
| Measure |
Azacitidine
n=34 Participants
75 mg/m\^2 Subcutaneous daily for 7 days every 4 weeks
|
|---|---|
|
Number of Participants With Objective Clinical Response
Complete Response
|
0 Participants
|
|
Number of Participants With Objective Clinical Response
Partial Response
|
1 Participants
|
|
Number of Participants With Objective Clinical Response
Hematologic Improvement
|
7 Participants
|
|
Number of Participants With Objective Clinical Response
No Response
|
26 Participants
|
Adverse Events
Azacitidine
Serious events: 17 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azacitidine
n=34 participants at risk
75 mg/m\^2 Subcutaneous daily for 7 days every 4 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Hyperuricemia
|
5.9%
2/34 • Number of events 2 • 2 years 9 months
|
|
Infections and infestations
Infection soft tissue
|
2.9%
1/34 • Number of events 1 • 2 years 9 months
|
|
Infections and infestations
Neutropenic Fever
|
5.9%
2/34 • Number of events 2 • 2 years 9 months
|
|
Cardiac disorders
CNS Cerebrovascular Ischema
|
2.9%
1/34 • Number of events 1 • 2 years 9 months
|
|
Gastrointestinal disorders
Nausea
|
8.8%
3/34 • Number of events 3 • 2 years 9 months
|
|
Gastrointestinal disorders
Vomiting
|
8.8%
3/34 • Number of events 3 • 2 years 9 months
|
|
Infections and infestations
Pneumonia
|
8.8%
3/34 • Number of events 3 • 2 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.9%
1/34 • Number of events 1 • 2 years 9 months
|
|
Infections and infestations
Non-Neutropenic Fever
|
5.9%
2/34 • Number of events 2 • 2 years 9 months
|
|
Vascular disorders
Neurology Intracranial Bleed
|
2.9%
1/34 • Number of events 1 • 2 years 9 months
|
|
General disorders
Edema
|
2.9%
1/34 • Number of events 1 • 2 years 9 months
|
|
Skin and subcutaneous tissue disorders
Skin Desquamation
|
2.9%
1/34 • Number of events 1 • 2 years 9 months
|
|
Blood and lymphatic system disorders
Neutropenia Without Fever
|
5.9%
2/34 • Number of events 2 • 2 years 9 months
|
|
Infections and infestations
Septic Arthritis Knee
|
2.9%
1/34 • Number of events 1 • 2 years 9 months
|
|
Infections and infestations
Bladder Infection
|
2.9%
1/34 • Number of events 1 • 2 years 9 months
|
|
Vascular disorders
Superficial Thrombosis
|
2.9%
1/34 • Number of events 1 • 2 years 9 months
|
|
Vascular disorders
Hemorrhage Post Surgical
|
2.9%
1/34 • Number of events 1 • 2 years 9 months
|
|
Cardiac disorders
Aortic Aneurism
|
2.9%
1/34 • Number of events 1 • 2 years 9 months
|
|
Infections and infestations
Urosepsis Infection
|
2.9%
1/34 • Number of events 1 • 2 years 9 months
|
|
Infections and infestations
Infection Laceration Knee
|
2.9%
1/34 • Number of events 1 • 2 years 9 months
|
|
Vascular disorders
Gastrointestinal Hemorrhage
|
2.9%
1/34 • Number of events 1 • 2 years 9 months
|
|
Infections and infestations
Gastrointestinal Infections
|
2.9%
1/34 • Number of events 1 • 2 years 9 months
|
Other adverse events
| Measure |
Azacitidine
n=34 participants at risk
75 mg/m\^2 Subcutaneous daily for 7 days every 4 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
29.4%
10/34 • Number of events 10 • 2 years 9 months
|
|
Renal and urinary disorders
Acute Renal Failure
|
5.9%
2/34 • Number of events 2 • 2 years 9 months
|
Additional Information
Srdan Verstovsek M.D./Associate Professor
The University of Texas M. D. Anderson Cancer Center
Phone: 713-792-7305
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place