Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT02719574) tested a drug called FT-2102 (also known as olutasidenib) in people with certain blood cancers, including acute myeloid leukaemia (AML) and a condition called myelodysplastic syndrome, that carried a specific gene change called an IDH1 mutation. The trial ran in two main stages: a Phase 1 stage to explore different doses and combinations (either FT-2102 alone or paired with other medicines called azacitidine or cytarabine), and a Phase 2 stage testing several groups of patients. In total, across all groups and stages, several hundred participants were enrolled — roughly 37 people in the Phase 1 dose-escalation stage, 41 in the Phase 1 dose-expansion stage, and 258 in the Phase 2 stage, giving an overall total of around 336 participants. The reported data shows that in Phase 1, one of the main things measured was how many participants experienced adverse events (unwanted medical events that occurred during treatment) and serious adverse events (those involving hospitalisation, life-threatening situations, or death). Among participants taking FT-2102 alone across both Phase 1 stages, 31 out of 31 participants experienced at least one adverse event during treatment, and 23 out of 31 experienced a serious adverse event. Among those taking FT-2102 combined with azacitidine, 39 out of 46 experienced at least one adverse event and 30 out of 46 experienced a serious adverse event. For Phase 2, the main thing measured was the percentage of patients who achieved a complete remission (meaning their cancer showed no detectable signs in bone marrow tests and their blood counts recovered) or a near-complete remission with partial blood count recovery. The reported data shows that in Cohort 1 (patients with relapsed or treatment-resistant AML taking FT-2102 alone), 35% of participants met this combined response measure. Results for other Phase 2 cohorts were also reported, though the full figures for all cohorts were not completely captured in the available data extract. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Leukaemia Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with a type of blood cancer called Acute Myeloid Leukemia (AML) — but not the specific subtype called Acute Promyelocytic Leukemia with a particular genetic change called t(15;17) — or a condition called Myelodysplastic Syndrome (MDS) that is classified as intermediate, high, or very high risk.
- Your cancer has come back, has not responded to standard treatments, cannot be treated with standard treatments, or has not responded well enough to standard treatments.
- Your cancer has been tested and found to have a specific gene change called the IDH1-R132 mutation.
- You are in generally good overall health and able to carry out daily activities (confirm with trial site for exact requirements).
- Your kidneys and liver are working well enough to meet the trial's requirements (confirm with trial site for exact levels).
Who may not be able to join:
- You have cancer that has spread to the brain or spinal cord and is causing symptoms, or you have another urgent complication such as severe bone fractures or a tumour pressing on important areas that requires immediate treatment.
- You have a serious heart condition, such as severe heart failure, unstable chest pain, a heart attack within the past year, blood pressure that cannot be controlled, or an uncontrolled irregular heartbeat.
- You currently have an active bacterial, viral, or fungal infection that is serious and requires treatment with medicines given throughout the body (such as IV or oral antibiotics).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs); Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values; Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG); Phase 2, Cohort 1: Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Partial Hematological Recovery (CRh) for Acute Myeloid Leukemia Assessed by Investigator Based on International Working Group (IWG) Response Criteria; P...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 7 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.