Leukemia, Myeloid, AcutePhase 1NCT03720366
A Study of Perpetrator Drug Interactions of Enasidenib in AML Patients
A Phase 1 study testing enasidenib, Arm 1 probes and Arm 2 Probes in people with Leukemia, Myeloid, Acute, run by Celgene at 10 sites in 2 countries.
Trial summary
This is a 2-part, open-label, interventional study conducted in approximately 42 subjects with AML harboring an IDH2 mutation. The overall study is a 3-arm investigation of the PK effects of enasidenib at steady state on the probe compounds. (Part 1), followed by treatment continuation up to 28 months (Part 2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- enasidenib, Arm 1 probes and Arm 2 Probes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 4 Oct 2018to 22 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must satisfy the following criteria to be enrolled in the study:
- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Subject is ≥ 18 years of age at the time of signing the ICF.
- Subject has either primary (ie, de novo) or secondary (associated with myelodysplastic syndrome [MDS], myeloproliferative neoplasms [MPN], or prior therapy with hematotoxins and/or radiation {ie, therapy-related disease}) AML according to the WHO classification.
- Subject either:
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- has received at least first line of AML therapy and any number of subsequent lines/regimens Note: For subjects having AML secondary to prior higher risk [Intermediate-2 or High risk according to the International Prognostic Scoring System] MDS treated with a hypomethylating agent [eg, azacitidine or decitabine], the hypomethylating therapy can be counted as a line/regimen if there is disease progression to AML during or shortly [eg, within 60 days] after the hypomethylating therapy.); or b. has never been treated for AML, but has declined standard of care chemotherapy.
- Subject has the following disease status:
- Refractory to, or relapsed after first, second, or third line regimen of intensive therapy for AML (eg, the "7 + 3" protocol) with at least 5% leukemic blasts in bone marrow (the minimum number of treatment cycles of the intensive therapy is per the investigator's discretion); or
- Refractory to, or relapsed after first, second or third line low-intensity AML therapy (eg, low dose cytarabine (LDAC), azacitidine or decitabine) with at least 5% leukemic blasts in bone marrow after at least 2 treatment cycles; or
- Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Subject has IDH2 gene mutations revealed by local testing in samples of bone marrow aspirate and/or peripheral blood, and confirmed positive in bone marrow aspirate and/or peripheral blood. Local testing may be performed during screening or within two months prior to screening with appropriate documentation and concurrence of Sponsor's Medical Monitor.
- Subject has adequate organ function defined as:
- Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 3 x upper limit of normal (ULN), unless considered to be due to leukemic organ involvement, following review by the Sponsor's Medical monitor; and
- Serum total bilirubin ≤ 1.5 x ULN, unless considered due to Gilbert's syndrome (eg, a gene mutation in UGT1A1) or leukemic organ involvement, following review by the Investigator and the Sponsor's Medical Monitor; and
- Estimated glomerular filtration rate (GFR) > 30 mL/min based on the Modification of Diet in Renal Disease (MDRD) formula: GFR (mL/min/1.73 m2) = 175 × (serum creatinine)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American)
- Females of childbearing potential (FCBP)2 may participate, providing they meet the following conditions:
- Agree to practice true abstinence from sexual intercourse or to use highly effective contraceptive methods (eg, combined [containing estrogen and progestogen] or progestogen-only associated with inhibition of ovulation, oral, injectable, intravaginal, patch, or implantable hormonal contraceptive; bilateral tubal occlusion; intra-uterine device; intrauterine hormone-releasing system; or male partner sterilization [note that vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the FCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success]) at screening and throughout the study, and for 4 months following the last study treatment; and
- Have a negative serum β-subunit of human chorionic gonadotropin (β-hCG) pregnancy test (sensitivity of at least 25 mIU/mL) at screening; and
- Have a negative serum β-hCG pregnancy test (sensitivity of at least 25 mIU/mL) within 72 hours prior to the start of study treatment in the Treatment Phase (note that the screening serum pregnancy test can be used as the test prior to the start of study treatment in the Treatment Phase if it is performed within the 72-hour timeframe).
- Male subjects must agree to practice true abstinence from sexual intercourse or to the use of highly effective contraceptive methods with non-pregnant female partners of childbearing potential at screening and throughout the course of the study, and should avoid conception with their partners during the course of the study and for 4 months following the last study treatment.
Who cannot join
- Presence of any of the following will exclude a subject from enrollment:
- Subject is suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype.
- Subject has AML secondary to chronic myeloid leukemia (CML).
- Subject has received a targeted agent against an IDH2 mutation.
- Prior treatment with an IDH2-targeted agent is acceptable if such treatment was interrupted for bone marrow or stem cell transplantation AND the patient was responsive to IDH2 treatment without progressive disease prior to transplantation.
- Subject has received systemic anticancer therapy or radiotherapy < 14 days prior to the start of study treatment. Note that hydroxyurea is allowed prior to the start of study treatment for the control of leukocytosis (however, hydroxyurea should not be given within 72 hours prior to and after administration of azacitidine).
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- Subject has received non-cytotoxic or investigational agents < 14 days or 5 half-lives, whichever is longer, prior to the start of study treatment.
- Subject has undergone hematopoietic stem cell transplantation (HSCT) within 60 days prior to the start of study treatment, or on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD).
- The use of a stable dose of oral steroid post-HSCT and/or topical steroids for ongoing skin GVHD is permitted.
- Subject has persistent, clinically significant non-hematologic toxicities from prior therapies.
- Subject has or is suspected of having central nervous system (CNS) leukemia.
- Evaluation of cerebrospinal fluid is only required if CNS involvement by leukemia is suspected during screening.
- Subject has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment).
- Subject has immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.
- Subject has significant active cardiac disease within 6 months prior to the start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and/or stroke; or left ventricular ejection fraction (LVEF) < 40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within 6 months starting study treatment.
- The LVEF should be representative of the subject's daily status (ie, not collected during temporary disturbances such as sepsis, acute cardiac drug toxicity, acute pulmonary embolism, etc).
- An imaging-based assessment of left ventricular function may be collected at Investigator's discretion as part of screening if needed to resolve uncertainty regarding prior tests or current clinical status.
- Subject is known seropositive or is infected with human immunodeficiency virus (HIV) or has active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Subject is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.
- Subject has uncontrolled hypertension (systolic blood pressure [BP] > 180 mmHg or diastolic BP > 100 mmHg).
- Subject is a pregnant or lactating female.
- Subject is known or suspected to have hypersensitivity to any of the components of PK probe compounds or study treatment.
- Note: A subject may be enrolled into an alternate arm of the study to which the subject does not have hypersensitivity if that alternate arm has not been filled, and if the alternate arm is available in the respective country. Subject is planning, or has reasonable probability, to violate the restrictions. Note in particular the medication restrictions.
- Subject has QTc interval (ie, Fridericia's correction [QTcF]) ≥ 480 ms or other factors that increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalemia, family history of long QT interval syndrome) at screening. Reversible factors such as hypokalemia or hypomagnesemia may be corrected prior to dosing if the Investigator and Sponsor's Medical Monitor concur.
- In conjunction with the restrictions, subject is taking the following CYP-sensitive substrate medications that have a narrow therapeutic range are excluded from the study unless the subject can be transferred to other medications at least 5 halflives prior to the start of study treatment: paclitaxel and docetaxel (CYP2C8), phenytoin (CYP2C9), S-mephenytoin (CYP2C19), thioridazine (CYP2D6), theophylline, and tizanidine (CYP1A2).
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk or would prevent the subject from participating in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Australia7 sites
Local Institution - 107
Adelaide, South Australia, 5000
Local Institution - 106
Clayton, Victoria, 3168
Local Institution - 103
Concord, New South Wales, 2139
Local Institution - 102
Heidelberg, Victoria, 3084
Local Institution - 101
Melbourne, 3141
Local Institution - 105
Nedlands, Western Australia, 6009
Local Institution - 104
Waratah, NSW
South Korea3 sites
Local Institution - 203
Seoul, 06351
Local Institution - 202
Seoul, 110-744
Local Institution - 201
Seoul, 5505
About this study
Official title: A Phase 1, 2-Part, Multicenter, Open-Label, 3-Arm Study to Determine the Effect of Enasidenib (CC-90007) on the Pharmacokinetics of Single Oral Doses of Caffeine, Dextromethorphan, Fexofenadine, Flurbiprofen, Midazolam, Omeprazole, Pioglitazone, and Rosuvastatin in Patients With Acute Myeloid Leukemia
This is a 2-part, open-label, interventional study conducted in approximately 42 subjects with AML harboring an IDH2 mutation.
The overall study is a 3-arm investigation of the PK effects of enasidenib at steady state on the probe compounds. (Part 1), followed by treatment continuation up to 28 months (Part 2).
Each arm utilizes different probe compounds; enrolls a separate cohort of approximately 14 subjects; and consists of 2 parts - investigation of the PK effects of enasidenib on the respective probe compound(s) (Part 1), followed by an enasidenib treatment extension (Part 2).
Read the detailed description
Subjects can only be enrolled in one treatment arm. The probes (which are given twice) used in the study are approved for use in the countries where the study will be conducted. The probes in Arm 1 consist of single doses of caffeine (100mg), dextromethorphan (30 mg), flurbiprofen (50 mg), midazolam (0.03 mg/kg), and omeprazole (40 mg). Arm 2 probes consist of digoxin (0.25 mg), and rosuvastatin (10 mg). Arm 3 probe is pioglitazone (15 mg). Enasidenib is administered orally. All probes, except for midazolam, are administered orally. Midazolam will be administered intravenously.
In Part 1 (equivalent to Cycle 1), eligible subjects will receive the probes on Day -1, followed by the first dose of enasidenib on Day 1. Enasidenib will continue to be taken once daily for 28 days. Blood samples for pharmacokinetic analysis will be collected according to a set schedule. Subjects will receive the probes a second time on Day 28. Part 2 of the study begins the next day when the subject begins a second round of daily enasidenib doses (equivalent to Cycle 2). Safety assessment s and procedures consistent with AML standard of care will continue.
- Conditions
- Leukemia, Myeloid, Acute
- Being tested
- enasidenib, Arm 1 probes, Arm 2 Probes, Arm 3 probes
- Keywords
- Enasidenib, CC-90007, Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enasidenibDrug
Also called CC-90007, AG-221
enasidenib
Arm 1 probesDrug
caffeine, dextromethorphan, flurbiprofen, midazolam, and omeprazole
Arm 2 ProbesDrug
digoxin and rosuvastatin
Arm 3 probesDrug
pioglitazone
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Administration of enasidenib and Arm 1 probes | Experimental | Part 1: Subjects will receive prescribed doses of Arm 1 probes on Day -1, followed by the first enasidenib dose on Day 1. Subjects will continue to take enasidenib once daily for 27 more days. On Day 28, subjects will receive the Arm 1 probes again together with the Day 28 dose of enasidenib. Part 2: the subjects continue to receive daily doses of enasidenib for the next 28 days (equivalent to a cycle). The subject will continue in subsequent cycles until the end of the study (28 months) or termination Receives: Drug: enasidenib; Drug: Arm 1 probes |
| Arm 2: Administration of enasidenib and Arm 2 probes | Experimental | Part 1: Subjects will receive prescribed doses of Arm 2 probes on Day -1, followed by the first enasidenib dose on Day 1. Subjects will continue to take enasidenib once daily for 27 more days. On Day 28, subjects will receive the Arm 2 probes again together with the Day 28 dose of enasidenib. Part 2: the subjects continue to receive daily doses of enasidenib for the next 28 days (equivalent to a cycle). The subject will continue in subsequent cycles until the end of the study (28 months) or termination Receives: Drug: enasidenib; Drug: Arm 2 Probes |
| Arm 3: Administration of Enasidenib and Arm 3 probes | Experimental | Part 1: Subjects will receive prescribed doses of Arm 3 probes on Day -1, followed by the first enasidenib dose on Day 1. Subjects will continue to take enasidenib once daily for 27 more days. On Day 28, subjects will receive the Arm 3 probes again together with the Day 28 dose of enasidenib. Part 2: the subjects continue to receive daily doses of enasidenib for the next 28 days (equivalent to a cycle). The subject will continue in subsequent cycles until the end of the study (28 months) or termination. Receives: Drug: enasidenib; Drug: Arm 3 probes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - AUC0-30
Area under the probe plasma concentration-time curve calculated from time zero to 30 hours
Measured: Up to approximately 29 days
Pharmacokinetics - Cmax
Observed maximum probe plasma concentration
Measured: Up to approximately 29 days
Secondary outcomes (6)
Pharmacokinetics - AUC0-∞
Area under the probe plasma concentration time curve from time zero to infinity
Measured: Up to approximately 29 days
Pharmacokinetics -t1/2,z
Terminal elimination half life for the probes
Measured: Up to approximately 29 days
Pharmacokinetics - CL/F
Apparent clearance of probes from plasma
Measured: Up to approximately 29 days
Pharmacokinetics - Vz/F
Apparent total volume of distribution of the probes, based on the terminal phase
Measured: Up to approximately 29 days
Complete Response Rate
Measurement of tumor size reduction by a predefined amount over the defined time period
Measured: Up to approximately 28 months
Adverse Events (AEs)
Number of participants with adverse events
Measured: Up to approximately 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start4 Oct 2018
- Primary completion22 Sep 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720366
- Sponsor's protocol ID
- CC-90007-CP-004
- Other IDs
- U1111-1218-1974
- Status last verified
- Feb 2024
- First submitted
- 24 Oct 2018
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 2-Part, Multicenter, Open-Label, 3-Arm Study to Determine the Effect of Enasidenib (CC-90007) on the Pharmacokinetics of Single Oral Doses of Caffeine, Dextromethorphan, Fexofenadine, Flurbiprofen, Midazolam, Omeprazole, Pioglitazone, and Rosuvastatin in Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT03720366
- Acronym / sponsor ID
- CC-90007-CP-004
- Conditions
- Leukemia, Myeloid, Acute
- Keywords
- Enasidenib, CC-90007, Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 2-part, open-label, interventional study conducted in approximately 42 subjects with AML harboring an IDH2 mutation.
The overall study is a 3-arm investigation of the PK effects of enasidenib at steady state on the probe compounds. (Part 1), followed by treatment continuation up to 28 months (Part 2).
Each arm utilizes different probe compounds; enrolls a separate cohort of approximately 14 subjects; and consists of 2 parts - investigation of the PK effects of enasidenib on the respective probe compound(s) (Part 1), followed by an enasidenib treatment extension (Part 2).
Detailed description
Subjects can only be enrolled in one treatment arm. The probes (which are given twice) used in the study are approved for use in the countries where the study will be conducted. The probes in Arm 1 consist of single doses of caffeine (100mg), dextromethorphan (30 mg), flurbiprofen (50 mg), midazolam (0.03 mg/kg), and omeprazole (40 mg). Arm 2 probes consist of digoxin (0.25 mg), and rosuvastatin (10 mg). Arm 3 probe is pioglitazone (15 mg). Enasidenib is administered orally. All probes, except for midazolam, are administered orally. Midazolam will be administered intravenously.
In Part 1 (equivalent to Cycle 1), eligible subjects will receive the probes on Day -1, followed by the first dose of enasidenib on Day 1. Enasidenib will continue to be taken once daily for 28 days. Blood samples for pharmacokinetic analysis will be collected according to a set schedule. Subjects will receive the probes a second time on Day 28. Part 2 of the study begins the next day when the subject begins a second round of daily enasidenib doses (equivalent to Cycle 2). Safety assessment s and procedures consistent with AML standard of care will continue.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Administration of enasidenib and Arm 1 probes | Experimental | Drug: enasidenib, Drug: Arm 1 probesPart 1: Subjects will receive prescribed doses of Arm 1 probes on Day -1, followed by the first enasidenib dose on Day 1. Subjects will continue to take enasidenib once daily for 27 more days. On Day 28, subjects will receive the Arm 1 probes again together with the Day 28 dose of enasidenib. Part 2: the subjects continue to receive daily doses of enasidenib for the next 28 days (equivalent to a cycle). The subject will continue in subsequent cycles until the end of the study (28 months) or termination |
| Arm 2: Administration of enasidenib and Arm 2 probes | Experimental | Drug: enasidenib, Drug: Arm 2 ProbesPart 1: Subjects will receive prescribed doses of Arm 2 probes on Day -1, followed by the first enasidenib dose on Day 1. Subjects will continue to take enasidenib once daily for 27 more days. On Day 28, subjects will receive the Arm 2 probes again together with the Day 28 dose of enasidenib. Part 2: the subjects continue to receive daily doses of enasidenib for the next 28 days (equivalent to a cycle). The subject will continue in subsequent cycles until the end of the study (28 months) or termination |
| Arm 3: Administration of Enasidenib and Arm 3 probes | Experimental | Drug: enasidenib, Drug: Arm 3 probesPart 1: Subjects will receive prescribed doses of Arm 3 probes on Day -1, followed by the first enasidenib dose on Day 1. Subjects will continue to take enasidenib once daily for 27 more days. On Day 28, subjects will receive the Arm 3 probes again together with the Day 28 dose of enasidenib. Part 2: the subjects continue to receive daily doses of enasidenib for the next 28 days (equivalent to a cycle). The subject will continue in subsequent cycles until the end of the study (28 months) or termination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Subject is ≥ 18 years of age at the time of signing the ICF.
- Subject has either primary (ie, de novo) or secondary (associated with myelodysplastic syndrome [MDS], myeloproliferative neoplasms [MPN], or prior therapy with hematotoxins and/or radiation {ie, therapy-related disease}) AML according to the WHO classification.
- Subject either:
Key exclusion criteria (27 listed)
- Subject is suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype.
- Subject has AML secondary to chronic myeloid leukemia (CML).
- Subject has received a targeted agent against an IDH2 mutation.
- Subject has received systemic anticancer therapy or radiotherapy < 14 days prior to the start of study treatment. Note that hydroxyurea is allowed prior to the start of study treatment for the control of leukocytosis (however, hydroxyurea should not be given within 72 hours prior to and after administration of azacitidine).
- Subject has received non-cytotoxic or investigational agents < 14 days or 5 half-lives, whichever is longer, prior to the start of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enasidenibAlso: CC-90007, AG-221enasidenib | Drug | Arm 1: Administration of enasidenib and Arm 1 probes, Arm 2: Administration of enasidenib and Arm 2 probes, Arm 3: Administration of Enasidenib and Arm 3 probes |
| Arm 1 probescaffeine, dextromethorphan, flurbiprofen, midazolam, and omeprazole | Drug | Arm 1: Administration of enasidenib and Arm 1 probes |
| Arm 2 Probesdigoxin and rosuvastatin | Drug | Arm 2: Administration of enasidenib and Arm 2 probes |
| Arm 3 probespioglitazone | Drug | Arm 3: Administration of Enasidenib and Arm 3 probes |
Primary outcome
Pharmacokinetics - AUC0-30
Time frame: Up to approximately 29 days
Area under the probe plasma concentration-time curve calculated from time zero to 30 hours
Pharmacokinetics - Cmax
Time frame: Up to approximately 29 days
Observed maximum probe plasma concentration
6 secondary outcomes
Pharmacokinetics - AUC0-∞
Time frame: Up to approximately 29 days
Pharmacokinetics -t1/2,z
Time frame: Up to approximately 29 days
Pharmacokinetics - CL/F
Time frame: Up to approximately 29 days
Pharmacokinetics - Vz/F
Time frame: Up to approximately 29 days
Complete Response Rate
Time frame: Up to approximately 28 months
Adverse Events (AEs)
Time frame: Up to approximately 28 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing enasidenib, Arm 1 probes and Arm 2 Probes in people with Leukemia, Myeloid, Acute, run by Celgene at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics - AUC0-30 (time frame: Up to approximately 29 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.