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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003596-34 | EudraCT Number |
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Study has been stopped following the strategic decision from the Sponsor. Not based on any safety findings or safety concerns with siremadlin.
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The purpose of this study was to confirm a safe dose and schedule as well as the preliminary efficacy of siremadlin alone, and in combination with donor lymphocyte infusion (DLI), in adult participants with Acute Myeloid Leukemia (AML) who were in remission following allogeneic stem cell transplantation (allo-SCT) but were at high risk for relapse based on the presence of pre-transplant risk factors.
This is a Phase Ib/II, single arm, open label, multi-center study of siremadlin as monotherapy and in combination with DLI, in adult participants with AML.
The primary purpose of the study was to confirm the safe dose and schedule of siremadlin monotherapy and in combination with DLI. The study is also designed to assess the preliminary efficacy in preventing hematologic relapse.
The study was initially planned to enroll approximately 38 participants starting with a dose confirmation of siremadlin monotherapy (part 1) to determine the siremadlin recommended dose, followed by a treatment strategy of siremadlin/DLI (Part 2).
After enrolling 8 participants (at the starting dose 30 mg/day on days 1-5 of a 28-day treatment cycle) in part 1, Novartis took the decision to put the enrollment in permanent halt and terminate the siremadlin program. For that reason, the enrollment in part 2 will not be open. The Novartis decision was not driven by any safety concerns.
In part 1 approximately 12 participants were planned to be enrolled in 2 cohorts (starting dose 30 mg/day on days 1-5 of a 28-day treatment cycle, dose level +1 at 40 mg/day and dose level -1 at 20 mg/day) and participants were planned to be treated for a maximum of 24 cycles.
In part 2, participants were planned to follow a treatment strategy, which contains three consecutive phases for a maximum of 24 cycles in total:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Siremadlin (HDM201) | Experimental | Participants with AML post allogeneic stem cell transplantation (allo-SCT) received siremadlin monotherapy in part 1 and were to have received siremadlin monotherapy as well as in combination with donor lymphocyte infusion in part 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siremadlin | Drug | Siremadlin was administered at a starting dose of 30 mg/day on days 1-5 of a 28-day treatment cycle (Part 1). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Dose Limiting Toxicities (DLTs) With Siremadlin Monotherapy in Part 1 (Dose Confirmation With Siremadlin Monotherapy) | To determine the dose and schedule of siremadlin monotherapy that are tolerable without unacceptable toxicities as defined by the incidence of DLT during the first cycle of treatment in part 1. 'A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed, by the Investigator, to be at least possibly related to study treatment (siremadlin monotherapy and/or siremadlin in combination with Donor lymphocyte infusion (DLI)), and as unrelated to disease, disease progression, inter-current illness, or concomitant medications, that occurs during the DLT observation period and meets severity criteria as per protocol. | from cycle 1 day 1 (C1D1) to end of Cycle 1 (cycle = 28days) |
| Time to Dose Limiting Toxicity (DLT) With Siremadlin in Combination With Donor Lymphocyte Infusion (DLI), in Part 2 | To determine the dose and schedule of siremadlin in combination with DLI that are tolerable without unacceptable toxicities (siremadlin recommended dose for combination), defined as time from start of combination phase to first DLT observed during the entire combination phase. | From Day 1 of combination Cycle 1 to Day 42 of the last cycle of combination phase (up to 3 cycles of siremadlin/DLI combination). Cycle duration: 42 days |
| Percentage of Participants Who Are Alive and Maintained Complete Remission (CR) or Complete Response With Incomplete Hematological Recovery (CRi) With no Evidence of Hematologic Relapse (Part 2) | This involves evaluating the preliminary efficacy of siremadlin (as monotherapy, in priming and/or maintenance, with or without siremadlin in combination with DLI) on the prevention of hematologic relapse. | Over 6 months from start of study treatment strategy (part 2 - siremadlin/DLI treatment strategy) |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Who Are Alive and Maintained CR or CRi With no Evidence of Hematologic Relapse (Part 1 -Siremadlin Monotherapy at the Recommended Dose for Part 2 ) | This involves evaluating the preliminary efficacy of siremadlin monotherapy at the recommended dose for part 2 on prevention of hematologic relapse | Over 6 months from start of siremadlin monotherapy (part 1) |
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Inclusion Criteria:
Participants with AML diagnosis, who underwent one allo-SCT to treat AML and are currently at ≥ Day 60 but no later than Day 120 (≤ Day 120) post allo-SCT.
Pre-allo-SCT - Participants must have any of the following risk factors that put them at high risk for relapse:
• AML in first CR (CR1) prior to allo-SCT with one of the following:
Adverse risk genetic abnormalities per 2017 ELN risk stratification. Patients with TP53 mutant AML at diagnosis are eligible if they meet eligibility criteria.
Therapy-related AML (t-AML).
Secondary AML (sAML) [AML secondary to antecedent myelodysplastic syndrome (MDS) or AML secondary to myeloproliferative neoplasm (MPN)].
• AML in second or greater CR (≥CR2) prior to allo-SCT.
Allo-SCT must have the following characteristics:
Donor lymphocytes are collected, cryopreserved and available for infusion (DLI), or obtaining donor lymphocytes for DLI is feasible (applicable only for part 2)
Post-allo-SCT, participants must have achieved CR or CRi with no current evidence of hematologic relapse
Eastern Cooperative Oncology Group (ECOG ) performance status 0, 1 or 2.
Laboratory test results indicating adequate liver and kidney function laboratory test results
Evidence of adequate engraftment: Absolute Neutrophil Count (ANC) ≥ 1.0x109/L, Platelets (PLT) ≥ 75x109/L, Hemoglobin (Hgb) ≥ 8 g/dL (within 14 days prior to start of study treatment)
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Augsburg | 86179 | Germany | |||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Prior to dosing at Cycle 1 Day 1, participants who fulfilled all the inclusion/exclusion criteria were enrolled via IRT and a treatment number was provided for the study treatment siremadlin.
38 participants were planned to be enrolled; 12 participants in Part 1 and 26 participants in Part 2; however, due to permanent recruitment halt, the enrollment was stopped after the 1st dose escalation meeting. The study was conducted in 6 centers in 3 countries: Germany, Italy and Spain.
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| ID | Title | Description |
|---|---|---|
| FG000 | Siremadlin (HDM201) 30mg | Participants with AML post allogeneic stem cell transplantation (allo-SCT) received 30mg siremadlin monotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 18, 2022 | Sep 4, 2024 |
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Study started out a phase l/ll study but because it was terminated, it never made it to phase ll.
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| Time From Start of Study Treatment to the Date of First Documented Hematologic Relapse or Death Due to Any Cause, Whichever Occurs First | Assessment of relapse free survival (RFS) in part 2 | From start of study treatment to up to 36 months from last patient first treatment |
| Cumulative Incidence of AML Relapse at 1 Year and 2 Years After Start of Study Treatment | Cumulative incidence of Acute Myeloid Leukemia (AML) relapse at one year and 2 years after the start of study treatment in part 1 and 2. Cumulative incidence of relapse (CIR) is defined as the time from start of study treatment to the date of first documented hematologic relapse. CIR was to be analyzed in the FAS population who initiated priming phase at siremadlin recommended dose (RD) in Part 2 and participants at the RD in Part 1. | 1 year and 2 years after start of study treatment |
| Time From Start of Study Treatment to the Date of Death From Any Cause | Assessment of Overall survival (OS) in part 2 | From start of study treatment to up to 36 months from last patient first treatment |
| Incidence of Graft Versus Host Disease (GvHD) | Incidence of grade III or IV acute GvHD, and moderate to severe chronic GvHD in part 1. Part 2 never started. | From start of study treatment up to approx. 8 months |
| Percentage of Participants With Permanent Study Treatment Discontinuation Due to GvHD or Other Adverse Events | Percentage of participants with permanent discontinuation of study treatment due to GvHD or other adverse events in part 1. As part 2 was not started, there were no participants to analyze in part 2. | From start of study treatment up to approx. 8 months |
| Time From Start of Study Treatment to the Date of First Documented Occurrence or Worsening of Treatment Emergent Grade III or IV Acute GvHD, or Chronic GvHD Requiring Initiation of Systemic Immunosuppressive Treatment | Assessment of GvHD-free/relapse-free survival (GRPF) in Part 1 and 2. According to the study protocol, time-to-event endpoints in Part 1 were planned to be analyzed using Kaplan-Meier method only for participants who received siremadlin at the recommended dose for Part 2. | From start of treatment up to approx. 8 months |
| Pharmacokinetic (PK) Characteristic AUC of Siremadlin | AUC is the area under the concentration vs. time curve in part 1 and was based on plasma concentration. Part 2 did not open for enrollment due to recruitment halt and so no data was analyzed. AUClast: The AUC from time zero to the last quantifiable concentration point (Tlast) (mass x time x volume-1). AUC0-t: The area under the concentration vs. time Curve (AUC) from time zero to specified time point. | AUC from time 0 to 8hr postdose, AUC0- 8hr (Cycle 1 Day 1, Cycle 1 Day 5) in part 1 [each cycle is 28 days for monotherapy] |
| PK Characteristic Cmax of Siremadlin | The maximum (peak) observed plasma drug concentration following drug administration (mass x volume^-1) in part 1. Part 2 did not open for enrollment due to recruitment halt and so no data was analyzed. | from 0 to 24 hrs post-dose (Cycle 1 Day 1), from 0 to 8 hr post-dose (Cycle 1 Day 5) in part 1 [each cycle is 28 days for monotherapy] |
| PK Characteristic Tmax of Siremadlin | The time to reach maximum (peak) plasma drug concentration after drug administration (time) in part 1. Part 2 did not open for enrollment due to recruitment halt and so no data was analyzed. | from 0 to 24 hrs post-dose (Cycle 1 Day 1), from 0 to 8 hr post-dose (Cycle 1 Day 5) in part 1 [each cycle is 28 days for monotherapy] |
| PK Characteristic Ctrough of Siremadlin | Concentration that is just prior to the beginning of, or at the end of a dosing interval; corresponding to the pre-dose concentration in part 1 and 2. Part 2 never started. | Cycle 1 Day 1, Cycle 1 Day 5 in part 1; [each cycle is 28 days] |
| Freiburg im Breisgau |
| 79106 |
| Germany |
| Novartis Investigative Site | Bergamo | BG | 24127 | Italy |
| Novartis Investigative Site | Bologna | BO | 40138 | Italy |
| Novartis Investigative Site | Seville | Andalusia | 41013 | Spain |
| Novartis Investigative Site | Valencia | 46026 | Spain |
| Entered Post-treatment Follow-up |
|
| Did Not Enter Post-treatment Follow-up |
|
| On 10mg (Due to Concomitant Medication to Prevent Overexposure) |
|
| COMPLETED | Not completed = Discontinued from study, not treatment |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS): FAS comprises all participants who received any study drug (i.e., at least one dose of siremadlin with or without Donor lymphocyte infusion (DLI)). Only the siremadlin 30 mg arm was opened for enrollment in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Siremadlin (HDM201) 30mg | Participants with AML post allogeneic stem cell transplantation (allo-SCT) received 30mg siremadlin monotherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Dose Limiting Toxicities (DLTs) With Siremadlin Monotherapy in Part 1 (Dose Confirmation With Siremadlin Monotherapy) | To determine the dose and schedule of siremadlin monotherapy that are tolerable without unacceptable toxicities as defined by the incidence of DLT during the first cycle of treatment in part 1. 'A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed, by the Investigator, to be at least possibly related to study treatment (siremadlin monotherapy and/or siremadlin in combination with Donor lymphocyte infusion (DLI)), and as unrelated to disease, disease progression, inter-current illness, or concomitant medications, that occurs during the DLT observation period and meets severity criteria as per protocol. | Dose Determining Set (DDS): The Dose Determining Set (DDS) includes participants in the dose determination phase who met specific treatment cycles, exposure criteria, follow-up/DLT observation, and safety evaluations, or experienced a DLT during the observation period. Only the 30 mg siremadlin arm was opened for enrollment, and patients needing dose reduction during Cycle 1 were not analyzed separately. | Posted | Count of Participants | Participants | from cycle 1 day 1 (C1D1) to end of Cycle 1 (cycle = 28days) |
|
|
| ||||||||||||||||||||||||||
| Primary | Time to Dose Limiting Toxicity (DLT) With Siremadlin in Combination With Donor Lymphocyte Infusion (DLI), in Part 2 | To determine the dose and schedule of siremadlin in combination with DLI that are tolerable without unacceptable toxicities (siremadlin recommended dose for combination), defined as time from start of combination phase to first DLT observed during the entire combination phase. | Part 2 did not open for enrollment due to recruitment halt, so no data was analyzed hence no data to report. | Posted | From Day 1 of combination Cycle 1 to Day 42 of the last cycle of combination phase (up to 3 cycles of siremadlin/DLI combination). Cycle duration: 42 days |
|
| |||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Are Alive and Maintained Complete Remission (CR) or Complete Response With Incomplete Hematological Recovery (CRi) With no Evidence of Hematologic Relapse (Part 2) | This involves evaluating the preliminary efficacy of siremadlin (as monotherapy, in priming and/or maintenance, with or without siremadlin in combination with DLI) on the prevention of hematologic relapse. | Part 2 did not open for enrollment due to recruitment halt, so no data was analyzed hence no data to report. | Posted | Over 6 months from start of study treatment strategy (part 2 - siremadlin/DLI treatment strategy) |
|
| |||||||||||||||||||||||||||||
| Secondary | Participants Who Are Alive and Maintained CR or CRi With no Evidence of Hematologic Relapse (Part 1 -Siremadlin Monotherapy at the Recommended Dose for Part 2 ) | This involves evaluating the preliminary efficacy of siremadlin monotherapy at the recommended dose for part 2 on prevention of hematologic relapse | Participants who received siremadlin monotherapy at the recommended dose for Part 2. The recommended dose for Part 2 could not be determined and therefore there were no patients meeting the reporting criteria for this endpoint. | Posted | Over 6 months from start of siremadlin monotherapy (part 1) |
|
| |||||||||||||||||||||||||||||
| Secondary | Time From Start of Study Treatment to the Date of First Documented Hematologic Relapse or Death Due to Any Cause, Whichever Occurs First | Assessment of relapse free survival (RFS) in part 2 | Part 2 did not open for enrollment due to recruitment halt, so no data was analyzed hence no data to report. | Posted | From start of study treatment to up to 36 months from last patient first treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of AML Relapse at 1 Year and 2 Years After Start of Study Treatment | Cumulative incidence of Acute Myeloid Leukemia (AML) relapse at one year and 2 years after the start of study treatment in part 1 and 2. Cumulative incidence of relapse (CIR) is defined as the time from start of study treatment to the date of first documented hematologic relapse. CIR was to be analyzed in the FAS population who initiated priming phase at siremadlin recommended dose (RD) in Part 2 and participants at the RD in Part 1. | Participants who received siremadlin at the recommended dose (RD) for Part 2 and had available efficacy data at 1 year and 2 years after start of study treatment. The RD for Part 2 could not be determined and there were no patients with efficacy data collected at 1 year and 2 years after start of study treatment. Therefore, there were no patients meeting the reporting criteria for this endpoint. | Posted | 1 year and 2 years after start of study treatment |
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| Secondary | Time From Start of Study Treatment to the Date of Death From Any Cause | Assessment of Overall survival (OS) in part 2 | Part 2 did not open for enrollment due to recruitment halt, so no data was analyzed hence no data to report. | Posted | From start of study treatment to up to 36 months from last patient first treatment |
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| Secondary | Incidence of Graft Versus Host Disease (GvHD) | Incidence of grade III or IV acute GvHD, and moderate to severe chronic GvHD in part 1. Part 2 never started. | Safety Set: Safety set includes all participants from the Full Analysis Set (FAS), i.e. all participants who received any study drug (i.e., at least one dose of siremadlin with or without DLI). Only the siremadlin 30 mg arm was opened for enrollment, and patients requiring any dose reduction throughout the study were not analyzed separately. | Posted | Count of Participants | Participants | From start of study treatment up to approx. 8 months |
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| Secondary | Percentage of Participants With Permanent Study Treatment Discontinuation Due to GvHD or Other Adverse Events | Percentage of participants with permanent discontinuation of study treatment due to GvHD or other adverse events in part 1. As part 2 was not started, there were no participants to analyze in part 2. | Safety Set: Safety set includes all participants from the Full Analysis Set (FAS), i.e. all participants who received any study drug (i.e., at least one dose of siremadlin with or without DLI). Only the siremadlin 30 mg arm was opened for enrollment, and patients requiring any dose reduction throughout the study were not analyzed separately. | Posted | Count of Participants | Participants | From start of study treatment up to approx. 8 months |
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| Secondary | Time From Start of Study Treatment to the Date of First Documented Occurrence or Worsening of Treatment Emergent Grade III or IV Acute GvHD, or Chronic GvHD Requiring Initiation of Systemic Immunosuppressive Treatment | Assessment of GvHD-free/relapse-free survival (GRPF) in Part 1 and 2. According to the study protocol, time-to-event endpoints in Part 1 were planned to be analyzed using Kaplan-Meier method only for participants who received siremadlin at the recommended dose for Part 2. | Participants who received siremadlin monotherapy at the recommended dose for Part 2, and participants enrolled in Part 2. The recommended dose for Part 2 could not be determined and Part 2 was not opened, and therefore there were no patients meeting the reporting criteria for this endpoint. | Posted | From start of treatment up to approx. 8 months |
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| Secondary | Pharmacokinetic (PK) Characteristic AUC of Siremadlin | AUC is the area under the concentration vs. time curve in part 1 and was based on plasma concentration. Part 2 did not open for enrollment due to recruitment halt and so no data was analyzed. AUClast: The AUC from time zero to the last quantifiable concentration point (Tlast) (mass x time x volume-1). AUC0-t: The area under the concentration vs. time Curve (AUC) from time zero to specified time point. | Pharmacokinetic Analysis Set (PAS): PAS includes all participants in the safety set who provide at least one evaluable PK concentration of siremadlin. One participant from the 30mg cohort received a siremadlin reduced dose of 10 mg due to coadministration of a strong CYP3A4 inhibitor as per protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | AUC from time 0 to 8hr postdose, AUC0- 8hr (Cycle 1 Day 1, Cycle 1 Day 5) in part 1 [each cycle is 28 days for monotherapy] |
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| Secondary | PK Characteristic Cmax of Siremadlin | The maximum (peak) observed plasma drug concentration following drug administration (mass x volume^-1) in part 1. Part 2 did not open for enrollment due to recruitment halt and so no data was analyzed. | Pharmacokinetics Analysis Set (PAS): PAS includes all participants in the safety set who provide at least one evaluable PK concentration of siremadlin. One participant from the 30mg cohort received a siremadlin reduced dose of 10 mg due to coadministration of a strong CYP3A4 inhibitor as per protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | from 0 to 24 hrs post-dose (Cycle 1 Day 1), from 0 to 8 hr post-dose (Cycle 1 Day 5) in part 1 [each cycle is 28 days for monotherapy] |
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| Secondary | PK Characteristic Tmax of Siremadlin | The time to reach maximum (peak) plasma drug concentration after drug administration (time) in part 1. Part 2 did not open for enrollment due to recruitment halt and so no data was analyzed. | Pharmacokinetics Analysis Set (PAS): PAS includes all participants in the safety set who provide at least one evaluable PK concentration of siremadlin. One participant from the 30mg cohort received a siremadlin reduced dose of 10 mg due to coadministration of a strong CYP3A4 inhibitor as per protocol. | Posted | Median | Full Range | hour (hr) | from 0 to 24 hrs post-dose (Cycle 1 Day 1), from 0 to 8 hr post-dose (Cycle 1 Day 5) in part 1 [each cycle is 28 days for monotherapy] |
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| Secondary | PK Characteristic Ctrough of Siremadlin | Concentration that is just prior to the beginning of, or at the end of a dosing interval; corresponding to the pre-dose concentration in part 1 and 2. Part 2 never started. | Pharmacokinetics Analysis Set (PAS): PAS includes all participants in the safety set who provide at least one evaluable PK concentration of siremadlin. One participant from the 30mg cohort received a siremadlin reduced dose of 10 mg due to coadministration of a strong CYP3A4 inhibitor as per protocol. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Day 1, Cycle 1 Day 5 in part 1; [each cycle is 28 days] |
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Adverse events were collected from first dose of study treatment to 30 days after last dose of study treatment (on-treatment). Subjects remaining in the study after end of treatment (EOT) (responders and non-responders, regardless of when treatment was discontinued) were followed up to approx. 8 months to collect long term data survival including: survival, relapse/progression of the underlying hematologic disease.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Only the siremadlin 30 mg arm was opened for enrollment, and patients requiring any dose reduction throughout the study were not analyzed separately.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Siremadlin (HDM201) 30mg | Participants with AML post allogeneic stem cell transplantation (allo-SCT) received 30mg siremadlin monotherapy | 2 | 8 | 2 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| External ear pain | Ear and labyrinth disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Corneal exfoliation | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute graft versus host disease | Immune system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Chronic graft versus host disease | Immune system disorders | MedDRA (26.1) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Endometrial thickening | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e., data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Office | Novartis Pharmaceuticals | 862-778-3000 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 29, 2023 | Sep 4, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000654196 | siremadlin |
Not provided
Not provided
Not provided
|
|
| Units | Counts |
|---|
| Participants |
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