Relapsed or Refractory Acute Myeloid LeukemiaPhase 1NCT04176393
A China Bridging Study of Ivosidenib in r/r AML Subjects With an IDH1 Mutation
A Phase 1 study testing ivosidenib in people with Relapsed or Refractory Acute Myeloid Leukemia, run by CStone Pharmaceuticals at 1 site in China.
Trial summary
This is a phase 1, multi-center, single-arm study to evaluate the pharmacokinetics(PK)/ pharmacodynamics(PD), safety, and clinical efficacy of orally administered Ivosidenib in Chinese subjects with R/R AML with an IDH1 mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Acute Myeloid Leukemia
- What is being tested?
- ivosidenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2019to 18 Jan 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 be ≥ 18 years of age.
- Subjects must have R/R AML
- Subjects must have documented IDH1 R132 gene-mutated based on the central evaluation.
- Subjects must have ECOG PS of 0 to 2.
- Subjects must be amenable to serial bone marrow sampling and peripheral blood samplings during the study.
- Subjects must have adequate hepatic function as evidenced by Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN), unless considered due to Gilbert's disease or leukemic involvement and Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement.
- Subjects must have an adequate renal function as evidenced by Serum creatinine ≤ 2.0 × ULN or Creatinine clearance >40 mL/min based on the Cockcroft-Gault glomerular filtration rate (GFR) estimation.
- Subjects must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer.
Who cannot join
- Subjects who previously received prior treatment with a mutant-specific IDH1 inhibitor and progressed on therapy.
- Subjects who have undergone HSCT within 60 days of the first dose of ivosidenib, or subjects on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD).
- Subjects who received systemic anticancer therapy or radiotherapy < 14 days prior to their first day of ivosidenib administration. Hydroxyurea and leukapheresis are allowed prior to enrollment and after the start of ivosidenib for the control of leukocytosis to reduce peripheral leukemic blasts.
- Subjects who received an investigational agent < 14 days prior to their first day of study drug administration.
- Subjects who received traditional Chinese medicine with known anti-cancer indication < 14 days prior to their first day of study drug administration.
- Subjects for whom potentially curative anticancer therapy is available.
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- Subjects with an active severe infection that required anti-infective therapy or with an unexplained fever > 38.5°C during screening visits or on their first day of study drug administration (at the discretion of the Investigator, subjects with tumor fever may be enrolled).7. Subjects who are pregnant or breastfeeding.
- Subjects with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF < 40% by an echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within approximately 28 days of C1D1.
- Subjects with a history of myocardial infarction within the last 6 months of screening.
- Subjects with known unstable or uncontrolled angina pectoris.
- Subjects with a known history of severe and/or uncontrolled ventricular arrhythmias.
- Subjects with known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.
- Subjects with clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid is only required if there is a clinical suspicion of CNS involvement by leukemia during screening.
- Subjects with immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.
- Subjects with a known medical history of progressive multifocal leukoencephalopathy.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality
About this study
Official title: A Phase 1, Multicenter, Single-Arm Study Evaluating Pharmacokinetic, Pharmacodynamic, Safety, and Clinical Efficacy of Orally Administered Ivosidenib in Chinese Subjects With Relapsed or Refractory Acute Myeloid Leukemia With an IDH1 Mutation
This is a phase 1, multi-center, single-arm study to evaluate the pharmacokinetics(PK)/ pharmacodynamics(PD), safety, and clinical efficacy of orally administered Ivosidenib in Chinese subjects with R/R AML with an IDH1 mutation.
- Being tested
- ivosidenib
- Medical subject headings
- Recurrence, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivosidenibDrug
Also called TIBSOVO
subjects will receive a single dose of ivosidenib 500 mg on Day -3 (i.e., 3 days prior to the start of daily dosing) and undergo PK/PD assessments over 72 hours to evaluate drug concentrations and 2-HG levels. Following that, subjects will be treated with ivosidenib 500 mg once a day (QD) PO continuously (28-day cycles, there are no inter-cycle rest periods).
| Study group | Role | What they receive |
|---|---|---|
| Ivosidenib (CS3010) tablet | Experimental | Ivosidenib (CS3010) tablet Receives: Drug: ivosidenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration(Cmax)
Measured: Measured on Day-3, Cyele1 Day1, Cycle1 Day15,Cycle2 Day1,Cycle3 Day1,Cycle4 Day1 (each cycle is 28 days)
Area under the plasma concentration versus time curve(AUC)
Measured: Measured on Day-3, Cyele1 Day1, Cycle1 Day15,Cycle2 Day1,Cycle3 Day1,Cycle4 Day1 (each cycle is 28 days)
The time to Cmax (Tmax)
Measured: Measured on Day-3, Cyele1 Day1, Cycle1 Day15,Cycle2 Day1,Cycle3 Day1,Cycle4 Day1 (each cycle is 28 days)
Half-life（t1/2）
Measured: Measured on Day-3, Cyele1 Day1, Cycle1 Day15,Cycle2 Day1,Cycle3 Day1,Cycle4 Day1 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start12 Nov 2019
- Primary completion18 Feb 2021
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CStone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176393
- Sponsor's protocol ID
- CS3010-101
- Status last verified
- Feb 2023
- First submitted
- 29 Oct 2019
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Single-Arm Study Evaluating Pharmacokinetic, Pharmacodynamic, Safety, and Clinical Efficacy of Orally Administered Ivosidenib in Chinese Subjects With Relapsed or Refractory Acute Myeloid Leukemia With an IDH1 Mutation
- ClinicalTrials.gov ID
- NCT04176393
- Acronym / sponsor ID
- CS3010-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CStone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 25 Nov 2019 (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 phase 1, multi-center, single-arm study to evaluate the pharmacokinetics(PK)/ pharmacodynamics(PD), safety, and clinical efficacy of orally administered Ivosidenib in Chinese subjects with R/R AML with an IDH1 mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivosidenib (CS3010) tablet | Experimental | Drug: ivosidenibIvosidenib (CS3010) tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must be ≥ 18 years of age.
- Subjects must have R/R AML
- Subjects must have documented IDH1 R132 gene-mutated based on the central evaluation.
- Subjects must have ECOG PS of 0 to 2.
- Subjects must be amenable to serial bone marrow sampling and peripheral blood samplings during the study.
Key exclusion criteria (15 listed)
- Subjects who previously received prior treatment with a mutant-specific IDH1 inhibitor and progressed on therapy.
- Subjects who have undergone HSCT within 60 days of the first dose of ivosidenib, or subjects on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD).
- Subjects who received systemic anticancer therapy or radiotherapy < 14 days prior to their first day of ivosidenib administration. Hydroxyurea and leukapheresis are allowed prior to enrollment and after the start of ivosidenib for the control of leukocytosis to reduce peripheral leukemic blasts.
- Subjects who received an investigational agent < 14 days prior to their first day of study drug administration.
- Subjects who received traditional Chinese medicine with known anti-cancer indication < 14 days prior to their first day of study drug administration.
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 |
|---|---|---|
| ivosidenibAlso: TIBSOVOsubjects will receive a single dose of ivosidenib 500 mg on Day -3 (i.e., 3 days prior to the start of daily dosing) and undergo PK/PD assessments over 72 hours to evaluate drug concentrations and 2-HG levels. Following that, subjects will be treated with ivosidenib 500 mg once a day (QD) PO continuously (28-day cycles, there are no inter-cycle rest periods). | Drug | Ivosidenib (CS3010) tablet |
Primary outcome
Peak Plasma Concentration(Cmax)
Time frame: Measured on Day-3, Cyele1 Day1, Cycle1 Day15,Cycle2 Day1,Cycle3 Day1,Cycle4 Day1 (each cycle is 28 days)
Area under the plasma concentration versus time curve(AUC)
Time frame: Measured on Day-3, Cyele1 Day1, Cycle1 Day15,Cycle2 Day1,Cycle3 Day1,Cycle4 Day1 (each cycle is 28 days)
The time to Cmax (Tmax)
Time frame: Measured on Day-3, Cyele1 Day1, Cycle1 Day15,Cycle2 Day1,Cycle3 Day1,Cycle4 Day1 (each cycle is 28 days)
Half-life（t1/2）
Time frame: Measured on Day-3, Cyele1 Day1, Cycle1 Day15,Cycle2 Day1,Cycle3 Day1,Cycle4 Day1 (each cycle is 28 days)
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 13 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ivosidenib in people with Relapsed or Refractory Acute Myeloid Leukemia, run by CStone Pharmaceuticals at 1 site in China.
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 8 inclusion and 15 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 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Peak Plasma Concentration(Cmax) (time frame: Measured on Day-3, Cyele1 Day1, Cycle1 Day15,Cycle2 Day1,Cycle3 Day1,Cycle4 Day1 (each cycle is 28 days)). The study lists 4 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 13 Feb 2023.