Acute Myeloid Leukemia (AML)Phase 1NCT02826642
A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia
A Phase 1 study testing IDH305 in people with Acute Myeloid Leukemia (AML), run by Novartis Pharmaceuticals.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and potential efficacy of IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- IDH305
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 26 Aug 2016to 29 Nov 2016
- 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
- -- Previously untreated AML. Patients with untreated, high or very high risk MDS (according to rIPSS or equivalent) are also permitted in Arm 2.
- Documentation of IDH1R132 mutation of tumor
- ECOG performance status ≤ 2
- Clinically fit for standard of care medication per protocol.
Who cannot join
- Prior treatment for AML or MDS
- Any severe or uncontrolled medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease.
- Acute Promyelocytic Leukemia
- Women who are pregnant or lactating
- Other protocol-defined Inclusion/Exclusion may apply
About this study
Official title: A Phase I, Open Label, Multicenter, Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia
The purpose of this study is to evaluate the safety, tolerability and potential efficacy of IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia (AML).
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- IDH305
- Keywords
- newly diagnosed acute myeloid leukemia, AML, myeloid dysplastic syndrome, MDS, IDH305, standard of care in IDH1 mutant 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.
IDH305Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Medically fit for induction | Experimental | IDH305 + Standard of care for patients that are medically fit for induction. Receives: Drug: IDH305 |
| Arm 2 Medically unfit for induction | Experimental | IDH305 + Standard of care for patients that are medically unfit for induction. Receives: Drug: IDH305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting toxicities
(escalation only)
Measured: 10 months
Number of patients with adverse events (AEs)
Measured: 36 months
Secondary outcomes (6)
Area Under Curve (AUC)
To characterize the PK profile of IDH305 with SOC medications (each Arm)
Measured: 36 months
Maximum Plasma Concentration (Cmax)
To characterize the PK profile of IDH305 with SOC medications (each Arm)
Measured: 36 months
Time taken to reach maximum plasma concentration (Tmax)
To characterize the PK profile of IDH305 with SOC medications (each Arm)
Measured: 36 months
Complete remission rate (CRR)
To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)
Measured: 36 months
Overall response rate (ORR)
To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)
Measured: 36 months
Event free survival (EFS)
To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start26 Aug 2016
- Primary completion29 Nov 2016 (estimated)
- Study completion29 Nov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826642
- Sponsor's protocol ID
- CIDH305X2102
- Status last verified
- Apr 2019
- First submitted
- 13 Jun 2016
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Multicenter, Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02826642
- Acronym / sponsor ID
- CIDH305X2102
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- newly diagnosed acute myeloid leukemia, AML, myeloid dysplastic syndrome, MDS, IDH305, standard of care in IDH1 mutant acute myeloid leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2016 (actual)
- Primary completion
- 29 Nov 2016 (estimated)
- Study completion
- 29 Nov 2016 (estimated)
- First posted
- 11 Jul 2016 (estimated)
- 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.
The purpose of this study is to evaluate the safety, tolerability and potential efficacy of IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia (AML).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Medically fit for induction | Experimental | Drug: IDH305IDH305 + Standard of care for patients that are medically fit for induction. |
| Arm 2 Medically unfit for induction | Experimental | Drug: IDH305IDH305 + Standard of care for patients that are medically unfit for induction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -- Previously untreated AML. Patients with untreated, high or very high risk MDS (according to rIPSS or equivalent) are also permitted in Arm 2.
- Documentation of IDH1R132 mutation of tumor
- ECOG performance status ≤ 2
- Clinically fit for standard of care medication per protocol.
Key exclusion criteria (5 listed)
- Prior treatment for AML or MDS
- Any severe or uncontrolled medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease.
- Acute Promyelocytic Leukemia
- Women who are pregnant or lactating
- Other protocol-defined Inclusion/Exclusion may apply
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 |
|---|---|---|
| IDH305 | Drug | Arm 1: Medically fit for induction, Arm 2 Medically unfit for induction |
Primary outcome
Dose Limiting toxicities
Time frame: 10 months
(escalation only)
Number of patients with adverse events (AEs)
Time frame: 36 months
6 secondary outcomes
Area Under Curve (AUC)
Time frame: 36 months
Maximum Plasma Concentration (Cmax)
Time frame: 36 months
Time taken to reach maximum plasma concentration (Tmax)
Time frame: 36 months
Complete remission rate (CRR)
Time frame: 36 months
Overall response rate (ORR)
Time frame: 36 months
Event free survival (EFS)
Time frame: 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IDH305 in people with Acute Myeloid Leukemia (AML), run by Novartis Pharmaceuticals.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Dose Limiting toxicities (time frame: 10 months). 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 10 Apr 2019.