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Mitochondrial Metabolism Inhibitor

Study Elesclomol Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1
Waitlist Available
Research Sponsored by Synta Pharmaceuticals Corp.
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 1 year
Awards & highlights
No Placebo-Only Group

Summary

This is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to patients with advanced myeloid leukemia.

Eligible Conditions
  • Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluation of adverse events based on frequency, causality, and severity as a measure of safety and tolerability.
Measurement of study drug concentrations to characterize pharmacokinetics.
Secondary study objectives
Assessment of Dose Limiting Toxicities and Response based on Peripheral Blood Counts and Bone Marrow

Side effects data

From 2016 Phase 2 trial • 58 Patients • NCT00888615
95%
Anemia
73%
Fatigue
66%
White Blood Cell Decreased
54%
Peripheral Sensory Neuropathy
54%
Nausea
48%
Neutrophil Count Decreased
45%
Constipation
45%
Alopecia
39%
Abdominal Pain
39%
Anorexia
32%
Hyperglycemia
30%
Dyspnea
27%
Diarrhea
27%
Vomiting
25%
Hypomagnesemia
25%
Insomnia
23%
Hypoalbuminemia
20%
Hypokalemia
18%
Platelet Count Decreased
18%
Cough
16%
Hypocalcemia
16%
Alkaline Phosphatase Increased
16%
Depression
16%
Edema Limbs
14%
Alanine Aminotransferase Increased
14%
Generalized Muscle Weakness
14%
Urinary Tract Infection
14%
Fever
13%
Bloating
13%
Creatinine Increased
13%
Hyponatremia
13%
Pain In Extremity
13%
Headache
13%
Abdominal Distension
11%
Back Pain
11%
Urinary Frequency
11%
Mucositis Oral
9%
Aspartate Aminotransferase Increased
9%
Myalgia
9%
Arthralgia
9%
Lymphocyte Count Decreased
9%
Dysgeusia
9%
Hot Flashes
9%
Anxiety
9%
Ascites
9%
Pain
7%
Weight Gain
7%
Rash Acneiform
7%
Hypertension
7%
Paresthesia
7%
Peripheral Motor Neuropathy
7%
Nasal Congestion
7%
Epistaxis
7%
Upper Respiratory Infection
5%
Blurred Vision
5%
Hypermagnesemia
5%
Dyspepsia
5%
Tinnitus
5%
Weight Loss
5%
Hypoglycemia
5%
Cholesterol High
5%
Hypertriglyceridemia
5%
Dehydration
5%
Rash Maculo-Papular
5%
Thromboembolic Event
5%
Nail Discoloration
5%
Bronchial Infection
5%
Urinary Tract Pain
4%
Dry Mouth
4%
Sinus Tachycardia
4%
Respiratory Failure
4%
Hearing Impaired
4%
Small Intestinal Obstruction
4%
Colonic Obstruction
4%
Stomach Pain
4%
Flatulence
4%
Blood Bilirubin Increased
4%
Investigations - Other
4%
Metabolism And Nutrition Disorders - Other
4%
Dizziness
4%
Neck Pain
4%
Dry Skin
4%
Lymphedema
4%
Pruritus
4%
Confusion
4%
Proteinuria
4%
Hematuria
4%
Oral Dysesthesia
4%
Gastroesophageal Reflux Disease
4%
Skin Infection
2%
Supraventricular Tachycardia
2%
Ventricular Arrhythmia
2%
Atrial Fibrillation
2%
Colonic Hemorrhage
2%
Cardiac Disorders - Other
2%
Watering Eyes
2%
Hypoxia
2%
Surgical And Medical Procedures - Other
2%
Blood And Lymphatic System Disorders - Other
2%
Ileus
2%
Palpitations
2%
Chest Pain - Cardiac
2%
Flashing Lights
2%
Pericardial Effusion
2%
Lung Infection
2%
Upper Gastrointestinal Hemorrhage
2%
Ejection Fraction Decreased
2%
Hypercalcemia
2%
Neoplasms Benign, Malignant And Unspecified (Incl
2%
Arthritis
2%
Tremor
2%
Somnolence
2%
Extrapyramidal Disorder
2%
Sinus Disorder
2%
Hypophosphatemia
2%
Hyperkalemia
2%
Glucose Intolerance
2%
Pleural Effusion
2%
Laryngopharyngeal Dysesthesia
2%
Dysphasia
2%
Scalp Pain
2%
Nail Loss
2%
Neuralgia
2%
Concentration Impairment
2%
Sore Throat
2%
Pneumonitis
2%
Pleuritic Pain
2%
Hoarseness
2%
Hypotension
2%
Flushing
2%
Nail Ridging
2%
Erythema Multiforme
2%
Floaters
2%
Device Related Infection
2%
Enterocolitis Infectious
2%
Spinal Fracture
2%
Fracture
2%
Fall
2%
Bruising
2%
Akathisia
2%
Delirium
2%
Renal And Urinary Disorders - Other
2%
Urinary Urgency
2%
Urinary Incontinence
2%
Chronic Kidney Disease
2%
Pelvic Pain
2%
Breast Pain
2%
Rectal Hemorrhage
2%
Lower Gastrointestinal Hemorrhage
2%
Flu Like Symptoms
2%
Facial Pain
2%
Edema Face
2%
Gait Disturbance
2%
Chills
2%
Tooth Infection
2%
Nail Infection
2%
Esophageal Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Paclitaxel, Elesclomol Sodium)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Elesclomol SodiumExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elesclomol Sodium
2010
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Synta Pharmaceuticals Corp.Lead Sponsor
37 Previous Clinical Trials
3,129 Total Patients Enrolled
~2 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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