Trial Outcomes & Findings for Phase II Study of Bevacizumab (Avastin®) in Myelofibrosis (NCT NCT00667277)

NCT ID: NCT00667277

Last Updated: 2014-08-22

Results Overview

Patient outcomes for myelofibrosis patients treated on a single agent bevacizumab. The two subjects who withdrew consent prior to initiation of therapy are included in the "patient refusal" category.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 13 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2014-08-22

Participant Flow

Subjects were enrolled in this study between May 2008 and March 2009

Participant milestones

Measure	Bevacizumab (Avastin) Use of bevacizumab (Avastin) in the treatment of myelofibrosis. bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)
Overall Study STARTED	13
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Bevacizumab (Avastin) Use of bevacizumab (Avastin) in the treatment of myelofibrosis. bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Phase II Study of Bevacizumab (Avastin®) in Myelofibrosis

Baseline characteristics by cohort

Measure	Bevacizumab (Avastin) n=13 Participants Use of bevacizumab (Avastin) in the treatment of myelofibrosis. bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)
Age, Continuous	69.6 years STANDARD_DEVIATION 11.0 • n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants
Diagnosis Primary Myelofibrosis (PMF)	8 participants n=93 Participants
Diagnosis Post-essential Thrombocythemia Myelofibrosis	3 participants n=93 Participants
Diagnosis Post-Polycythemia Vera Myelofibrosis (Post PV MF)	2 participants n=93 Participants

PRIMARY outcome

Timeframe: 2 years

Patient outcomes for myelofibrosis patients treated on a single agent bevacizumab.

The two subjects who withdrew consent prior to initiation of therapy are included in the "patient refusal" category.

Outcome measures

Measure	Bevacizumab (Avastin) n=13 Participants Use of bevacizumab (Avastin) in the treatment of myelofibrosis. bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)
Reason for Therapy Discontinuation Physician decision	6 participants
Reason for Therapy Discontinuation Patient Refusal	5 participants
Reason for Therapy Discontinuation Death	1 participants
Reason for Therapy Discontinuation End of study	1 participants

SECONDARY outcome

Timeframe: 2 years

Number of cycles of bevacizumab received. Patients received bevacizumab as a single agent at a dose of 15 mg/kg intravenously on Day 1 of a 21-day cycle.

Outcome measures

Measure	Bevacizumab (Avastin) n=11 Participants Use of bevacizumab (Avastin) in the treatment of myelofibrosis. bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)
Number of Cycles	3.1 cycles Standard Deviation 2.6

Adverse Events

Bevacizumab (Avastin)

Serious events: 7 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bevacizumab (Avastin) n=13 participants at risk Use of bevacizumab (Avastin) in the treatment of myelofibrosis. bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)
Cardiac disorders Death	7.7% 1/13 • Number of events 1
Cardiac disorders Left Ventricular Failure	7.7% 1/13 • Number of events 1
Nervous system disorders Peripheral Sensory Neuropathy	7.7% 1/13 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnea	23.1% 3/13 • Number of events 3
General disorders Weight Loss	7.7% 1/13 • Number of events 1
General disorders Fatigue	7.7% 1/13 • Number of events 1
Nervous system disorders Tremor	7.7% 1/13 • Number of events 1
Infections and infestations Pneumonia	15.4% 2/13 • Number of events 2

Other adverse events

Measure	Bevacizumab (Avastin) n=13 participants at risk Use of bevacizumab (Avastin) in the treatment of myelofibrosis. bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)
Blood and lymphatic system disorders Myelo-suppression	23.1% 3/13 • Number of events 7
Skin and subcutaneous tissue disorders Infection	7.7% 1/13 • Number of events 1
Vascular disorders Fluid Overload	7.7% 1/13 • Number of events 1
General disorders General Symptom	7.7% 1/13 • Number of events 1
Musculoskeletal and connective tissue disorders Malaise and Fatigue	15.4% 2/13 • Number of events 2
General disorders Headache	7.7% 1/13 • Number of events 1
General disorders Facial Pain	7.7% 1/13 • Number of events 1
Skin and subcutaneous tissue disorders Bruising	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Diarrhea	7.7% 1/13 • Number of events 2
Gastrointestinal disorders Constipation	15.4% 2/13 • Number of events 2
Infections and infestations Upper respiratory infection	7.7% 1/13 • Number of events 1
Musculoskeletal and connective tissue disorders Infective Myositis	7.7% 1/13 • Number of events 1
Infections and infestations Sinusitis	7.7% 1/13 • Number of events 1
Blood and lymphatic system disorders Edema Limbs	7.7% 1/13 • Number of events 1
Nervous system disorders Memory Impairment	15.4% 2/13 • Number of events 2
Nervous system disorders Dizziness	7.7% 1/13 • Number of events 1
Infections and infestations Urinary Tract Infection	7.7% 1/13 • Number of events 1
Musculoskeletal and connective tissue disorders Myalgia	7.7% 1/13 • Number of events 1
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 1/13 • Number of events 1
Hepatobiliary disorders Liver Function Test Abnormality	7.7% 1/13 • Number of events 4
Metabolism and nutrition disorders Metabolic Laboratory Abnormality	7.7% 1/13 • Number of events 3
Renal and urinary disorders Protein positive urine	7.7% 1/13 • Number of events 1
Respiratory, thoracic and mediastinal disorders Cough	7.7% 1/13 • Number of events 1

Additional Information

Dr. Ronald Hoffman

Icahn School of Medicine at Mount Sinai

Phone: (212) 241-2297

Email: ronald.hoffman@mssm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place