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Aminopeptidase inhibitor
Tosedostat for Acute Myeloid Leukemia
Phase 2
Waitlist Available
Research Sponsored by Chroma Therapeutics
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 protocol-mandated visits every 12 weeks
Awards & highlights
Study Summary
The purpose of this study is to evaluate the long-term efficacy and safety profile of tosedostat in elderly patients suffering from refractory or relapsed Acute Myeloid Leukemia.
Eligible Conditions
- Acute Myeloid Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ protocol mandated visits every 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~protocol mandated visits every 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Tolerability of extended treatment with tosedostat
Secondary outcome measures
Efficacy of extended treatment with tosedostat
Side effects data
From 2017 Phase 2 trial • 12 Patients • NCT0245234658%
Other - BNP increased
50%
Fatigue
50%
Electrocardiogram QT corrected interval prolonged
42%
Bruising
42%
Diarrhea
42%
Edema limbs
33%
Hypomagnesemia
25%
Alanine transferase increased
25%
Dyspnea
25%
Hypokalemia
25%
Platelet count decreased
25%
Urticaria
25%
Dizziness
25%
Dry skin
25%
Ejection fraction decreased
17%
Fall
17%
GGT increased
17%
Insomnia
17%
Neutrophil count decreased
17%
Pain in extremity
17%
Toothache
17%
Cough
17%
Febrile neutropenia
8%
Sore throat
8%
Sepsis
8%
Blurred vision
8%
Atrial fibrillation
8%
Creatinine increased
8%
Urinary incontinence
8%
Syncope
8%
Edema face
8%
Pulmonary hypertension
8%
Urinary tract infection
8%
Other - Muscle cramps
8%
Weight loss
8%
Fever
8%
Abdominal pain
8%
Alkaline phosphatase increased
8%
Allergic reaction
8%
Cardiac troponin I increased
8%
Confusion
8%
Constipation
8%
Delirium
8%
Hemorrhoids
8%
Hiccups
8%
Hypoxia
8%
INR increased
8%
Lethargy
8%
Other - Ferritin increased
8%
Other - Forgetfulness
8%
Other - left subconjunctival hemorrhage
8%
Other - Lip excoriation
8%
Other - Muscle spasm
8%
Other - Pneumonia
8%
Paresthesia, foot
8%
Pulmonary edema
8%
Rash pustular
8%
Anemia
8%
Aspartate aminotransferase increased
8%
Back pain
8%
Blood bilirubin increased
8%
Cognitive disturbance
8%
Depression
8%
Flank pain
8%
Fracture
8%
Gastroenteritis
8%
Hemorrhoidal hemorrhage
8%
Mucositis
8%
Nausea
8%
Neuralgia
8%
Non-cardiac chest pain
8%
Oral hemorrhage
8%
Other - Demand ischemia
8%
Epistaxis
8%
Dry mouth
8%
Vomiting
8%
Other - Decline in performance status
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Patients
Trial Design
1Treatment groups
Experimental Treatment
Group I: TosedostatExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tosedostat
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Chroma TherapeuticsLead Sponsor
9 Previous Clinical Trials
344 Total Patients Enrolled
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