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NEDD8-activating enzyme inhibitor

Pevonedistat for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Research Sponsored by Millennium Pharmaceuticals, Inc.
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 from first documentation of response up to disease progression ( up to 3.5 years)
Awards & highlights

Study Summary

A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems

Eligible Conditions
  • Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
  • Kidney Failure
  • Myelodysplastic Syndrome
  • Liver Disease
  • Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first documentation of response up to disease progression ( up to 3.5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first documentation of response up to disease progression ( up to 3.5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A, AUClast: Area Under the Plasma Concentration-time Curve from Time Zero to the Time of the Last Quantifiable Concentration for Pevonedistat Following a Single Dose
Part A, AUC∞: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity for Pevonedistat Following a Single Dose
Part A, Cmax: Maximum Observed Plasma Concentration for Pevonedistat Following a Single Dose
Secondary outcome measures
Part B, AUCτ: Area under the Concentration-time Curve from Time Zero to the end of the Dosing Interval for Pevonedistat and Azacitidine Following Multiple Dose
Part B, CL/F: Apparent Clearance for Azacitidine
Part B, CLR: Renal Clearance for Azacitidine
+15 more

Side effects data

From 2021 Phase 2 trial • 120 Patients • NCT02610777
47%
Constipation
45%
Nausea
44%
Anaemia
40%
Fatigue
35%
Pyrexia
34%
Cough
34%
Neutropenia
27%
Diarrhoea
26%
Dyspnoea
24%
Febrile neutropenia
24%
Thrombocytopenia
21%
Decreased appetite
21%
Asthenia
21%
Vomiting
19%
Arthralgia
18%
Hypokalaemia
16%
Abdominal pain
15%
Oedema peripheral
15%
Dizziness
13%
Pneumonia
13%
Back pain
13%
Headache
13%
Pruritus
11%
Platelet count decreased
11%
Bronchitis
11%
Injection site pain
11%
Insomnia
11%
Chills
10%
Epistaxis
10%
Fall
10%
Neutrophil count decreased
10%
Oral herpes
10%
Oropharyngeal pain
10%
White blood cell count decreased
8%
Erythema
8%
Aspartate aminotransferase increased
8%
Hypomagnesaemia
8%
Muscular weakness
8%
Stomatitis
8%
Urinary tract infection
8%
Weight decreased
8%
Pleural effusion
6%
Dehydration
6%
Musculoskeletal pain
6%
Hypophosphataemia
6%
Contusion
6%
Pain in extremity
6%
Productive cough
6%
Non-cardiac chest pain Pain
6%
Sepsis
6%
Alanine aminotransferase increased
6%
Hypoalbuminaemia
6%
Hypocalcaemia
6%
Hyponatraemia
6%
Malaise
6%
Nasal congestion
6%
Non-cardiac chest pain
6%
Oral candidiasis
6%
Petechiae
6%
Nasopharyngitis
3%
Cellulitis
3%
Cerebrovascular accident
3%
Gastric haemorrhage
2%
Atrial fibrillation
2%
Congestive cardiomyopathy
2%
Acute febrile neutrophilic dermatosis
2%
Embolic stroke
2%
Endocarditis
2%
Failure to thrive
2%
Gastrointestinal necrosis
2%
Hepatic lesion
2%
Lower respiratory tract infection
2%
Lung infiltration
2%
Multiple organ dysfunction syndrome
2%
Myocardial infarction
2%
Wound infection
2%
Postoperative hypotension
2%
Acute myeloid leukaemia
2%
Ankle fracture
2%
Arthritis
2%
Arthritis reactive
2%
Autoimmune haemolytic anaemia
2%
Bacteraemia
2%
Bacterial sepsis
2%
Bronchopulmonary aspergillosis
2%
Cauda equina syndrome
2%
Cholecystitis
2%
Drug hypersensitivity
2%
Gastrointestinal ulcer perforation
2%
Haematuria
2%
Haemorrhage intracranial
2%
Hypoxia
2%
Influenza
2%
Inguinal hernia
2%
Ischaemic gastritis
2%
Leukopenia
2%
Myelodysplastic syndrome
2%
Myelodysplastic syndrome transformation
2%
Post procedural hypotension
2%
Rectal haemorrhage
2%
Renal colic
2%
Respiratory tract infection
2%
Soft tissue infection
2%
Spinal compression fracture
2%
Urinary tract infection enterococcal
2%
Urinary tract obstruction
2%
Lung infection
2%
Chronic kidney disease
2%
Death
2%
Gastritis erosive
2%
Supraventricular tachycardia
2%
Thrombophlebitis superficial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azacitidine 75 mg/m^2
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2

Trial Design

4Treatment groups
Experimental Treatment
Group I: Renal Arm (Severe Renal Impairment)Experimental Treatment5 Interventions
Pevonedistat 20 mg/m^2, infusion, intravenously, once, on Day1 of Part A in participants with hematologic malignancies or solid tumors, followed by a washout period of approximately 4 to 7 days, further followed by azacitidine 75 mg/m^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day1 through Day7 or Day1 through Day5, and on Days 8-9 in combination with pevonedistat 15 mg/m^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies and docetaxel 75 mg/m^2 OR carboplatin AUC4, infusion, intravenously, once along with paclitaxel 135 mg/m^2, infusion, intravenously, once on Day 1 in combination with pevonedistat 15 mg/m^2, infusion, intravenously, on Days 3 and 5 in each 21-day treatment cycle in participants with solid tumors until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Group II: Moderate Hepatic Arm (Moderate Hepatic Impairment)Experimental Treatment4 Interventions
Pevonedistat 20 mg/m^2, infusion, intravenously, once, on Day 1 of Part A in participants with hematologic malignancies or solid tumors, followed by a washout period of approximately 4 to 7 days, further followed by azacitidine 75 mg/m^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 in combination with pevonedistat 10 mg/m^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies, and carboplatin AUC4, infusion, intravenously, once along with paclitaxel 90 mg/m^2, infusion, intravenously, once on Day 1 in combination with pevonedistat 10 mg/m^2, infusion, intravenously, on Days 3 and 5 in each 21-day treatment cycle in participants with solid tumors until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Group III: Mild Hepatic Arm (Mild Hepatic Impairment)Experimental Treatment4 Interventions
Pevonedistat 20 mg/m^2, infusion, intravenously, once, on Day 1 of Part A in participants with hematologic malignancies or solid tumors, followed by a washout period of approximately 4 to 7 days, further followed by azacitidine 75 mg/m^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 in combination with pevonedistat 20 mg/m^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies, and carboplatin AUC4, infusion, intravenously, once along with paclitaxel 135 mg/m^2, infusion, intravenously, once on Day 1 in combination with pevonedistat 20 mg/m^2, infusion, intravenously, on Days 3 and 5 in each 21-day treatment cycle in participants with solid tumors until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Group IV: Control Arm (Normal Renal and Hepatic Function)Experimental Treatment2 Interventions
Pevonedistat 20 milligram per square meter (mg/m^2), infusion, intravenously, once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days, further followed by azacitidine 75 mg/m^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 in combination with pevonedistat 20 mg/m^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pevonedistat
2021
Completed Phase 2
~290
Docetaxel
1995
Completed Phase 4
~5620
Carboplatin
2014
Completed Phase 3
~6670
Azacitidine
2012
Completed Phase 3
~1440
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Lead Sponsor
404 Previous Clinical Trials
46,897 Total Patients Enrolled
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,245 Total Patients Enrolled
Medical DirectorStudy DirectorMillennium Pharmaceuticals, Inc.
2,777 Previous Clinical Trials
8,063,463 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
A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems
2019. "A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03814005.
~3 spots leftby Apr 2025
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