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Aurora Kinase Inhibitor

Alisertib for Myelofibrosis

N/A
Waitlist Available
Led By Brady Stein, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to up to 6 months after the last dose of treatment
Awards & highlights

Study Summary

This trial is studying alisertib to see how well it works in treating patients with AMKL or MF.

Eligible Conditions
  • Myelofibrosis
  • Megakaryoblastic Leukemia
  • Primary Myelofibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to up to 6 months after the last dose of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to up to 6 months after the last dose of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Secondary outcome measures
Response to Treatment
Other outcome measures
Primary Myelofibrosis
Changes in Biomarker Expression Levels
Changes in MF Symptoms Assessed by the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) Score (MF Patients)
+2 more

Side effects data

From 2017 Phase 2 trial • 178 Patients • NCT02038647
55%
Diarrhoea
47%
Neutropenia
44%
Anaemia
44%
Fatigue
34%
Nausea
33%
Decreased appetite
32%
Vomiting
31%
Stomatitis
24%
Dyspnoea
20%
Cough
17%
Dizziness
16%
Neutrophil count decreased
16%
Alopecia
16%
Asthenia
15%
Weight decreased
14%
Leukopenia
14%
Abdominal pain
14%
White blood cell count decreased
11%
Hypokalaemia
10%
Arthralgia
10%
Febrile neutropenia
10%
Headache
9%
Constipation
9%
Neuropathy peripheral
9%
Pyrexia
9%
Dyspepsia
8%
Thrombocytopenia
8%
Dehydration
8%
Hypocalcaemia
8%
Insomnia
8%
Abdominal pain upper
7%
Muscular weakness
7%
Oedema peripheral
6%
Dysphonia
6%
Hypomagnesaemia
6%
Dysphagia
6%
Gastrooesophageal reflux disease
6%
Fall
6%
Somnolence
6%
Back pain
6%
Hyperglycaemia
6%
Hypertension
5%
Musculoskeletal pain
5%
Hypoaesthesia
5%
Productive cough
5%
Non-cardiac chest pain
5%
Paraesthesia
3%
Epistaxis
3%
Pain in extremity
3%
Respiratory failure
3%
Pneumonia
3%
General physical health deterioration
2%
Pulmonary embolism
2%
Neutropenic sepsis
2%
Dysgeusia
2%
Confusional state
2%
Lung neoplasm malignant
2%
Upper respiratory tract infection
1%
Ataxia
1%
Seizure
1%
Acute respiratory failure
1%
Pulmonary oedema
1%
Mental status changes
1%
Embolism
1%
Pancytopenia
1%
Influenza
1%
Fungal infection
1%
Paraplegia
1%
Oral herpes
1%
Metastases to meninges
1%
Diabetic metabolic decompensation
1%
Aortic thrombosis
1%
Cardiac failure
1%
Acute coronary syndrome
1%
Bacteraemia
1%
Sepsis
1%
Septic shock
1%
Respiratory tract infection
1%
Glioblastoma
1%
Tumour pain
1%
Systemic inflammatory response syndrome
1%
Bile duct stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Paclitaxel
Alisertib + Paclitaxel

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (alisertib)Experimental Treatment3 Interventions
Patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alisertib
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,205 Total Patients Enrolled
The Leukemia and Lymphoma SocietyOTHER
82 Previous Clinical Trials
17,105 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,127 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia
Brady Stein 2015. "Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02530619.
All > Fibrosis > Myelofibrosis
~3 spots leftby Apr 2025
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