Study Summary
This trial is testing a new combination of drugs for relapsed or refractory AML patients. The first part of the trial will determine the maximum tolerated dose of the new drugs. The second part will expand the trial to more patients using the maximum tolerated dose.
Eligible Conditions
- Acute Myeloid Leukemia
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 7 years
7 years
Adverse event profile of CC-486 in combination with venetoclax
Determine the maximum tolerated dose of CC-486 in combination with venetoclax
Trial Safety
Safety Progress
Side Effects for
CC-486 200 mg
100%Nausea
50%Diarrhoea
50%Neutropenia
50%Fatigue
50%Vomiting
33%Arthralgia
33%Febrile neutropenia
33%Decreased appetite
33%Stomatitis
33%Neutrophil count decreased
17%Sinus tachycardia
17%Ear infection
17%Hypokalaemia
17%Cough
17%Pneumonia
17%Thrombocytopenia
17%Diverticulitis
17%Oral candidiasis
17%Back pain
17%Diabetes insipidus
17%Headache
17%Inguinal hernia
17%Blood creatinine increased
17%Hyperammonaemia
17%Respiratory tract infection
17%Hypomagnesaemia
17%Pruritus generalised
17%Syncope
17%Rhinorrhoea
17%Bacteraemia
17%Hypothermia
17%Nosocomial infection
17%Oedema peripheral
17%Pyrexia
17%Neck pain
17%Humerus fracture
17%Brain oedema
17%Skin infection
17%Hyperglycaemia
17%Cerebrovascular accident
17%Dizziness
17%Hypocalcaemia
17%Hypoglycaemia
17%Hypoalbuminaemia
17%Toothache
17%Metabolic acidosis
17%Pain of skin
17%Musculoskeletal chest pain
17%Neuropathy peripheral
17%Productive cough
17%Insomnia
17%Anxiety
17%Decubitus ulcer
17%Rash maculo-papular
17%Hypotension
17%Anaemia
17%Eye oedema
17%Abdominal distension
17%Septic shock
17%Deafness unilateral
17%Dental caries
17%Constipation
17%Abdominal pain
17%Abdominal pain upper
17%Dyspepsia
17%Blood alkaline phosphatase increased
17%Aspartate aminotransferase increased
17%Upper respiratory tract infection
17%Alanine aminotransferase increased
17%Nasal congestion
17%Menstrual disorder
17%Pleural effusion
Trial Design
3 Treatment Groups
Cohort 2 CC-486 300 mg
1 of 3
Cohort 1 CC-486 200 mg
1 of 3
Dose Expansion Cohort
1 of 3
Experimental Treatment
22 Total Participants · 3 Treatment Groups
Primary Treatment: CC-486 · No Placebo Group · Phase 1
Cohort 2 CC-486 300 mgExperimental Group · 2 Interventions: CC-486, Venetoclax · Intervention Types: Drug, Drug
Cohort 1 CC-486 200 mgExperimental Group · 2 Interventions: CC-486, Venetoclax · Intervention Types: Drug, Drug
Dose Expansion CohortExperimental Group · 2 Interventions: CC-486, Venetoclax · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-486
2015
Completed Phase 2
~330
Venetoclax
2019
Completed Phase 3
~2170
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 7 years
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,496 Previous Clinical Trials
3,930,305 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,590 Previous Clinical Trials
1,927,216 Total Patients Enrolled
Daniel E Pollyea, MDPrincipal InvestigatorUniversity of Colorado, Denver
Eligibility Criteria
Age 18 - 100 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a projected life expectancy of at least 12 weeks.
You have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
AST ≤ 3.0 × ULN.\n
You have ALT ≤ 3.0 × ULN.\n
You have a creatinine clearance of 30 mL/min or greater.
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Conditions
Cancer Related
Treatments