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Mitochondrial Metabolism Inhibitor

Elesclomol Sodium for 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
Acceptable organ and marrow function during the screening period as defined by the protocol
Reliable venous access suitable for study drug infusions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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%
Alopecia
45%
Constipation
39%
Abdominal Pain
39%
Anorexia
32%
Hyperglycemia
30%
Dyspnea
27%
Diarrhea
27%
Vomiting
25%
Hypomagnesemia
25%
Insomnia
23%
Hypoalbuminemia
20%
Hypokalemia
18%
Cough
18%
Platelet Count Decreased
16%
Hypocalcemia
16%
Alkaline Phosphatase Increased
16%
Depression
16%
Edema Limbs
14%
Generalized Muscle Weakness
14%
Alanine Aminotransferase Increased
14%
Urinary Tract Infection
14%
Fever
13%
Bloating
13%
Hyponatremia
13%
Pain In Extremity
13%
Headache
13%
Creatinine Increased
13%
Abdominal Distension
11%
Back Pain
11%
Urinary Frequency
11%
Mucositis Oral
9%
Myalgia
9%
Arthralgia
9%
Hot Flashes
9%
Lymphocyte Count Decreased
9%
Aspartate Aminotransferase Increased
9%
Dysgeusia
9%
Anxiety
9%
Ascites
9%
Pain
7%
Nasal Congestion
7%
Rash Acneiform
7%
Hypertension
7%
Weight Gain
7%
Peripheral Motor Neuropathy
7%
Paresthesia
7%
Epistaxis
7%
Upper Respiratory Infection
5%
Hypoglycemia
5%
Thromboembolic Event
5%
Tinnitus
5%
Blurred Vision
5%
Dyspepsia
5%
Weight Loss
5%
Hypertriglyceridemia
5%
Hypermagnesemia
5%
Dehydration
5%
Rash Maculo-Papular
5%
Nail Discoloration
5%
Cholesterol High
5%
Bronchial Infection
5%
Urinary Tract Pain
4%
Dry Skin
4%
Small Intestinal Obstruction
4%
Lymphedema
4%
Respiratory Failure
4%
Sinus Tachycardia
4%
Hearing Impaired
4%
Dry Mouth
4%
Stomach Pain
4%
Metabolism And Nutrition Disorders - Other
4%
Neck Pain
4%
Dizziness
4%
Pruritus
4%
Colonic Obstruction
4%
Investigations - Other
4%
Blood Bilirubin Increased
4%
Flatulence
4%
Confusion
4%
Proteinuria
4%
Hematuria
4%
Oral Dysesthesia
4%
Gastroesophageal Reflux Disease
4%
Skin Infection
2%
Pneumonitis
2%
Sore Throat
2%
Sinus Disorder
2%
Pleural Effusion
2%
Neuralgia
2%
Ileus
2%
Lung Infection
2%
Hypoxia
2%
Surgical And Medical Procedures - Other
2%
Blood And Lymphatic System Disorders - Other
2%
Supraventricular Tachycardia
2%
Palpitations
2%
Cardiac Disorders - Other
2%
Ventricular Arrhythmia
2%
Chest Pain - Cardiac
2%
Watering Eyes
2%
Flashing Lights
2%
Upper Gastrointestinal Hemorrhage
2%
Hypophosphatemia
2%
Hyperkalemia
2%
Hypercalcemia
2%
Glucose Intolerance
2%
Arthritis
2%
Neoplasms Benign, Malignant And Unspecified (Incl
2%
Extrapyramidal Disorder
2%
Concentration Impairment
2%
Pleuritic Pain
2%
Laryngopharyngeal Dysesthesia
2%
Scalp Pain
2%
Nail Ridging
2%
Nail Loss
2%
Erythema Multiforme
2%
Hypotension
2%
Flushing
2%
Ejection Fraction Decreased
2%
Tremor
2%
Somnolence
2%
Hoarseness
2%
Atrial Fibrillation
2%
Pericardial Effusion
2%
Colonic Hemorrhage
2%
Dysphasia
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)

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025