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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002964-25 | EudraCT Number |
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Sponsor's decision to terminate the study after Phase 1; will not proceed with Phase 2.
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This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance for treating participants with acute myeloid leukemia (AML).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-Escalation Phase | Experimental | Participants with newly diagnosed, previously untreated, favorable or intermediate risk AML (according to European LeukemiaNet [ELN] 2017 criteria) will undergo the treatment sequence of induction, consolidation, and maintenance. For induction, participants will be treated with idasanutlin plus cytarabine and daunorubicin. At the investigator's discretion for consolidation, either participants will be treated with idasanutlin and cytarabine or they will undergo Allo-HSCT. For maintenance, participants will be treated with single-agent idasanutlin. |
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| Post-Consolidation Phase | Experimental | Participants who are idasanutlin treatment-naive, had received induction and chemotherapy consolidation for AML outside of the study, and were in minimal residual disease (MRD)-positive remission after induction will be enrolled in this cohort to receive maintenance treatment with single-agent idasanutlin. |
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| Expansion Phase: Favorable/Intermediate-Risk AML | Experimental | Participants with newly diagnosed, previously untreated, favorable or intermediate risk AML (according to ELN 2017 criteria) will undergo the treatment sequence of induction, consolidation, and maintenance. For induction, participants will be treated with idasanutlin (at the recommended Phase 2 dose) plus cytarabine and daunorubicin. At the investigator's discretion for consolidation, either participants will be treated with idasanutlin and cytarabine or they will undergo Allo-HSCT. For maintenance, participants will be treated with single-agent idasanutlin. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idasanutlin | Drug | Participants will self-administer idasanutlin tablets by mouth (PO) once daily (QD) for 5 days of each 28-day treatment cycle for up to 2 cycles of induction, up to 4 cycles of consolidation, and 12 cycles of maintenance, according to the study's protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation Phase: Number of Participants With Dose-Limiting Toxicities (DLTs) During the First Cycle of Induction Treatment | Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. The planned Phase 2 was not initiated. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML | Cycle 1 of induction treatment (1 cycle is 28 days) |
| Number of Participants With at Least One Adverse Event | Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. The planned Phase 2 was not initiated. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML. | From Baseline until 28 days after the final dose of study drug (up to 2 years) |
| Number of Participants With Grade ≥3 Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) | Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. The planned Phase 2 was not initiated. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML | From Baseline until 28 days after the final dose of study drug (up to 2 years) |
| Number of Participants Reporting Presence or Absence of Nausea Over Time, as Assessed Through Use of the National Cancer Institute (NCI) Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Day 1 of each treatment cycle (1 cycle is 28 days) and at study drug discontinuation (up to 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation and Expansion Phases: Percentage of Participants With a CR, Complete Remission With Incomplete Blood Count Recovery (CRi), or Complete Remission With Incomplete Platelet Count Recovery (CRp) at the End of Induction Treatment | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted |
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Inclusion Criteria:
Inclusion Criteria for All Study Phases:
Inclusion Criteria for Patients in the Dose-Escalation and Expansion Phases:
- Documented/confirmed newly diagnosed acute myeloid leukemia (AML) not previously treated according to World Health Organization (WHO)
Inclusion Criteria for Patients in the Post-Consolidation Phase:
- Documented/confirmed AML according to WHO in remission after induction, within 21 days of end of last chemotherapy consolidation cycle, and were minimum residual disease (MRD) positive at the end of induction as per local laboratory assessment
Exclusion Criteria:
Exclusion Criteria for All Study Phases:
Exclusion Criteria for Patients in the Phase Ib Dose-Escalation Phase:
- Adverse risk patients as per European LeukemiaNet (ELN) 2017 criteria
Exclusion Criteria for Patients in Phase Ib Post-Consolidation Phase:
Exclusion Criteria for Patients in the Dose-Escalation Phase and Patients in the Favorable/Intermediate-Risk Cohort of the Expansion Phase:
- Secondary AML, defined as AML evolving from antecedent hematologic disorder (AHD)
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States | ||
| Sarah Cannon Research Institute at HealthONE |
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose-Escalation Cohort 1 | 200 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction |
| FG001 | Dose Escalation Cohort 2 |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2018 |
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| Expansion Phase: High-Risk AML | Experimental | Participants with newly diagnosed, previously untreated, high-risk AML (defined as adverse risk according to ELN 2017 criteria, and secondary AML) will undergo the treatment sequence of induction, consolidation, and maintenance. For induction, participants will be treated with idasanutlin (at the recommended Phase 2 dose) plus cytarabine and daunorubicin. At the investigator's discretion for consolidation, either participants will be treated with idasanutlin and cytarabine or they will undergo Allo-HSCT. For maintenance, participants will be treated with single-agent idasanutlin. |
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| Cytarabine | Drug | Cytarabine will be administered for 7 days of each 28-day cycle for up to 2 cycles of induction treatment at a dose of 200 milligrams per meter squared (mg/m^2) of body surface area, once daily (QD) by intravenous (IV) infusion. At the investigator's discretion, cytarabine will also be administered as part of chemotherapy consolidation at a dose of 1.5 g/m^2 QD as IV infusion for 5 days of each 28-day cycle and for up to 4 cycles of treatment. |
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| Daunorubicin | Drug | Daunorubicin will be administered for 3 days of each 28-day cycle for up to 2 cycles of induction treatment at a dose of 60 mg/m^2 QD as IV infusion. |
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| Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT) | Procedure | After induction treatment, participants who achieve remission will either receive chemotherapy consolidation treatment or undergo Allo-HSCT (as per local guidelines) at the investigator's discretion. |
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| Change From Baseline Over Time in Reported Frequency of Nausea, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| Change From Baseline Over Time in Reported Severity of Nausea, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| Change From Baseline Over Time in Reported Degree of Interference With Daily Function Caused by Nausea, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| Change From Baseline Over Time in Overall Score for Nausea, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| Number of Participants Reporting Presence or Absence of Vomiting Over Time, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Day 1 of each treatment cycle (1 cycle is 28 days) and at study drug discontinuation (up to 2 years) |
| Change From Baseline Over Time in Reported Frequency of Vomiting, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| Change From Baseline Over Time in Reported Severity of Vomiting, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| Change From Baseline Over Time in Reported Degree of Interference With Daily Function Caused by Vomiting, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| Change From Baseline Over Time in Overall Score for Vomiting, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| Number of Participants Reporting Presence or Absence of Diarrhea Over Time, as Assessed Through Use of the NCI PRO-CTCAE Over Time | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Day 1 of each treatment cycle (1 cycle is 28 days) and at study drug discontinuation (up to 2 years) |
| Change From Baseline in Reported Frequency of Diarrhea Over Time, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| Change From Baseline in Reported Severity of Diarrhea Over Time, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| Change From Baseline in Reported Degree of Interference With Daily Function Caused by Diarrhea Over Time, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| Change From Baseline in Overall Score for Diarrhea Over Time, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| Number of Participants, Per ELN Categories, With a Complete Remission (CR) at the End of Induction Treatment, Among Those Treated at the Recommended Phase 2 Dose | Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML. Therefore this outcome measure was not conducted and no data available to report. | At the end of induction treatment (up to 2 cycles; 1 cycle is 28 days) |
| At the end of induction treatment (up to 2 cycles; 1 cycle is 28 days) |
| Dose Escalation and Expansion Phases: Percentage of Participants With a CR or Complete Remission With Partial Hematologic Recovery (CRh) at the End of Induction Treatment | Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. The planned Phase 2 was not initiated. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML. Therefore this outcome measure was not conducted and no data available to report. | At the end of induction treatment (up to 2 cycles; 1 cycle is 28 days) |
| Dose-Escalation and Expansion Phases: Percentage of Participants With a Negative Minimal Residual Disease (MRD) Status at the End of Induction Treatment | Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. The planned Phase 2 was not initiated. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML. Therefore this outcome measure was not conducted and no data available to report. | At the end of induction treatment (up to 2 cycles; 1 cycle is 28 days) |
| Post-Consolidation Phase: Percentage of Participants Converting From MRD-Positive to MRD-Negative Status at Any Time During Treatment | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | At the end of maintenance treatment (12 cycles, 1 cycle is 28 days) |
| Kaplan-Meier Estimate of the Percentage of Participants in Event-Free Survival | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Up to 5 years |
| Kaplan-Meier Estimate of the Percentage of Participants in Overall Survival | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Up to 5 years |
| Kaplan-Meier Estimate of the Percentage of Participants in Relapse-Free Survival in Those Who Achieve Remission (CR, CRi, CRp, or CRh) | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Up to 5 years |
| Change From Baseline Over Time in the Participant-Reported Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire Total Score | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of each cycle of induction and consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years) |
| Change From Baseline Over Time in Physical Function Scale Score of the Participant-Reported European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire, Core 30 (EORTC QLQ-C30) | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of first induction cycle only, Day 1 of each subsequent treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| Change From Baseline Over Time in Role Function Scale Score of the Participant-Reported EORTC QLQ-C30 | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of first induction cycle only, Day 1 of each subsequent treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| Change From Baseline Over Time in Global Health Status/Quality of Life Scale Score of the Participant-Reported EORTC QLQ-C30 | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of first induction cycle only, Day 1 of each subsequent treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| Change From Baseline Over Time in Headache Symptom Score of the Participant-Reported European Organisation for Research and Treatment of Cancer (EORTC) Item Library Questionnaire | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of each cycle of induction and consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years) |
| Change From Baseline Over Time in Dizziness Symptom Score of the Participant-Reported EORTC Item Library Questionnaire | The Sponsor decided not to continue the study based on the overall Company strategy in AML. Due to the limited The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of each cycle of induction and consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years) |
| Change From Baseline Over Time in Bruising Symptom Score of the Participant-Reported EORTC Item Library Questionnaire | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of each cycle of induction and consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years) |
| Change From Baseline Over Time in the European Quality of Life 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Utility Score | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of first induction cycle only, Day 1 of all cycles of consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years) |
| Change From Baseline Over Time in the EQ-5D-5L Visual Analogue Scale (VAS) Score | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Baseline, Day 1 of first induction cycle only, Day 1 of all cycles of consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years) |
| Area Under the Plasma Concentration-Time Curve (AUC) of Idasanutlin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; Days 1 and 5 of consolidation Cycle 1; and Days 1 and 5 of maintenance Cycle 1 (1 cycle is 28 days) |
| AUC of Cytarabine | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; and Days 1 and 5 of consolidation Cycle 1 (1 cycle is 28 days) |
| AUC of Daunorubicin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1 (1 cycle is 28 days) |
| Maximum Observed Plasma Concentration (Cmax) of Idasanutlin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; Days 1 and 5 of consolidation Cycle 1; and Days 1 and 5 of maintenance Cycle 1 (1 cycle is 28 days) |
| Cmax of Cytarabine | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; and Days 1 and 5 of consolidation Cycle 1 (1 cycle is 28 days) |
| Cmax of Daunorubicin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1 (1 cycle is 28 days) |
| Total Clearance (CL) of Idasanutlin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; Days 1 and 5 of consolidation Cycle 1; and Days 1 and 5 of maintenance Cycle 1 (1 cycle is 28 days) |
| CL of Cytarabine | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; and Days 1 and 5 of consolidation Cycle 1 (1 cycle is 28 days) |
| CL of Daunorubicin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1 (1 cycle is 28 days) |
| Volume of Distribution at Steady State (Vss) of Idasanutlin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; Days 1 and 5 of consolidation Cycle 1; and Days 1 and 5 of maintenance Cycle 1 (1 cycle is 28 days) |
| Vss of Cytarabine | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; and Days 1 and 5 of consolidation Cycle 1 (1 cycle is 28 days) |
| Vss of Daunorubicin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1 (1 cycle is 28 days) |
| Terminal Half-Life (t1/2) of Idasanutlin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; Days 1 and 5 of consolidation Cycle 1; and Days 1 and 5 of maintenance Cycle 1 (1 cycle is 28 days) |
| t1/2 of Cytarabine | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; and Days 1 and 5 of consolidation Cycle 1 (1 cycle is 28 days) |
| t1/2 of Daunorubicin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1 (1 cycle is 28 days) |
| Denver |
| Colorado |
| 80218 |
| United States |
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago | Illinois | 60637-1447 | United States |
| University of Iowa Hospitals and Clinics; Investigational Drug Services | Iowa City | Iowa | 52242 | United States |
| University of Kansas Clinical Research Center; Clinical Trials Office | Fairway | Kansas | 66205 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| State University of NY | Brooklyn | New York | 11203 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| The Alfred Hospital | Prahan | Victoria | 3181 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Centre Léon Bérard | Lyon | 69008 | France |
| Institut Paoli Calmettes | Marseille | 13009 | France |
| CHU de Nantes - Hotel Dieu | Nantes | 44093 | France |
| Hôpital Saint-Louis | Paris | 75475 | France |
| Institut Universitaire du Cancer de Toulouse-Oncopole | Toulouse | 31059 | France |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST); Onco-Ematologia | Meldola | Emilia-Romagna | 47014 | Italy |
| ASST Papa Giovanni XXIII; Dipartimento Interaziendale di Farmacia Clinica | Bergamo | Lombardy | 24127 | Italy |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz. | Madrid | 28040 | Spain |
| Hospital Universitario Virgen del RocÃo; Servicio de Neuropediatra | Seville | 41013 | Spain |
| Hospital Universitari i Politècnic La Fe | Valencia | Spain |
350 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
| FG002 | Dose Escalation Cohort 3 | 250 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction |
| FG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
| COMPLETED |
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| NOT COMPLETED |
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There was no expansion phase taken place.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dose-Escalation Cohort 1 | 200 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction |
| BG001 | Dose Escalation Cohort 2 | 350 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction |
| BG002 | Dose Escalation Cohort 3 | 250 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction |
| BG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Dose Escalation Phase: Number of Participants With Dose-Limiting Toxicities (DLTs) During the First Cycle of Induction Treatment | Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. The planned Phase 2 was not initiated. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML | ITT Population | Posted | Number | Participants | Cycle 1 of induction treatment (1 cycle is 28 days) |
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| Primary | Number of Participants With at Least One Adverse Event | Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. The planned Phase 2 was not initiated. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML. | Safety Population | Posted | Number | Percentage of Participants | From Baseline until 28 days after the final dose of study drug (up to 2 years) |
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| Primary | Number of Participants With Grade ≥3 Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) | Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. The planned Phase 2 was not initiated. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML | Safety Population | Posted | Number | Participants | From Baseline until 28 days after the final dose of study drug (up to 2 years) |
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| Primary | Number of Participants Reporting Presence or Absence of Nausea Over Time, as Assessed Through Use of the National Cancer Institute (NCI) Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Day 1 of each treatment cycle (1 cycle is 28 days) and at study drug discontinuation (up to 2 years) |
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| Primary | Change From Baseline Over Time in Reported Frequency of Nausea, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline Over Time in Reported Severity of Nausea, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline Over Time in Reported Degree of Interference With Daily Function Caused by Nausea, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
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| Primary | Change From Baseline Over Time in Overall Score for Nausea, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
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| Primary | Number of Participants Reporting Presence or Absence of Vomiting Over Time, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Day 1 of each treatment cycle (1 cycle is 28 days) and at study drug discontinuation (up to 2 years) |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline Over Time in Reported Frequency of Vomiting, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
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| Primary | Change From Baseline Over Time in Reported Severity of Vomiting, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline Over Time in Reported Degree of Interference With Daily Function Caused by Vomiting, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline Over Time in Overall Score for Vomiting, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
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| Primary | Number of Participants Reporting Presence or Absence of Diarrhea Over Time, as Assessed Through Use of the NCI PRO-CTCAE Over Time | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Day 1 of each treatment cycle (1 cycle is 28 days) and at study drug discontinuation (up to 2 years) |
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| Primary | Change From Baseline in Reported Frequency of Diarrhea Over Time, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
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| Primary | Change From Baseline in Reported Severity of Diarrhea Over Time, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
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| Primary | Change From Baseline in Reported Degree of Interference With Daily Function Caused by Diarrhea Over Time, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
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| Primary | Change From Baseline in Overall Score for Diarrhea Over Time, as Assessed Through Use of the NCI PRO-CTCAE | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
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| Primary | Number of Participants, Per ELN Categories, With a Complete Remission (CR) at the End of Induction Treatment, Among Those Treated at the Recommended Phase 2 Dose | Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML. Therefore this outcome measure was not conducted and no data available to report. | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | At the end of induction treatment (up to 2 cycles; 1 cycle is 28 days) |
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| Secondary | Dose Escalation and Expansion Phases: Percentage of Participants With a CR, Complete Remission With Incomplete Blood Count Recovery (CRi), or Complete Remission With Incomplete Platelet Count Recovery (CRp) at the End of Induction Treatment | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | At the end of induction treatment (up to 2 cycles; 1 cycle is 28 days) |
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| Secondary | Dose Escalation and Expansion Phases: Percentage of Participants With a CR or Complete Remission With Partial Hematologic Recovery (CRh) at the End of Induction Treatment | Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. The planned Phase 2 was not initiated. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML. Therefore this outcome measure was not conducted and no data available to report. | ITT Population. Analyzed population was the number of participants in Cohorts 1-3 from whom evaluable data were obtained. The Postconsidaltion cohort involved the participants in maintenance and were excluded. | Posted | At the end of induction treatment (up to 2 cycles; 1 cycle is 28 days) |
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| Secondary | Dose-Escalation and Expansion Phases: Percentage of Participants With a Negative Minimal Residual Disease (MRD) Status at the End of Induction Treatment | Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. The planned Phase 2 was not initiated. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML. Therefore this outcome measure was not conducted and no data available to report. | ITT Population. Analyzed population was the number of participants in Cohorts 1-3 from whom evaluable data were obtained. The Postconsidaltion cohort involved the participants in maintenance and were excluded. | Posted | At the end of induction treatment (up to 2 cycles; 1 cycle is 28 days) |
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| Secondary | Post-Consolidation Phase: Percentage of Participants Converting From MRD-Positive to MRD-Negative Status at Any Time During Treatment | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | At the end of maintenance treatment (12 cycles, 1 cycle is 28 days) |
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| Secondary | Kaplan-Meier Estimate of the Percentage of Participants in Event-Free Survival | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Up to 5 years |
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| Secondary | Kaplan-Meier Estimate of the Percentage of Participants in Overall Survival | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Up to 5 years |
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| Secondary | Kaplan-Meier Estimate of the Percentage of Participants in Relapse-Free Survival in Those Who Achieve Remission (CR, CRi, CRp, or CRh) | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Up to 5 years |
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| Secondary | Change From Baseline Over Time in the Participant-Reported Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire Total Score | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of each cycle of induction and consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years) |
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| Secondary | Change From Baseline Over Time in Physical Function Scale Score of the Participant-Reported European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire, Core 30 (EORTC QLQ-C30) | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of first induction cycle only, Day 1 of each subsequent treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
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| Secondary | Change From Baseline Over Time in Role Function Scale Score of the Participant-Reported EORTC QLQ-C30 | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of first induction cycle only, Day 1 of each subsequent treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
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| Secondary | Change From Baseline Over Time in Global Health Status/Quality of Life Scale Score of the Participant-Reported EORTC QLQ-C30 | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of first induction cycle only, Day 1 of each subsequent treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years) |
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| Secondary | Change From Baseline Over Time in Headache Symptom Score of the Participant-Reported European Organisation for Research and Treatment of Cancer (EORTC) Item Library Questionnaire | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of each cycle of induction and consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years) |
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| Secondary | Change From Baseline Over Time in Dizziness Symptom Score of the Participant-Reported EORTC Item Library Questionnaire | The Sponsor decided not to continue the study based on the overall Company strategy in AML. Due to the limited The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of each cycle of induction and consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years) |
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| Secondary | Change From Baseline Over Time in Bruising Symptom Score of the Participant-Reported EORTC Item Library Questionnaire | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of each cycle of induction and consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years) |
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| Secondary | Change From Baseline Over Time in the European Quality of Life 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Utility Score | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of first induction cycle only, Day 1 of all cycles of consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years) |
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| Secondary | Change From Baseline Over Time in the EQ-5D-5L Visual Analogue Scale (VAS) Score | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Baseline, Day 1 of first induction cycle only, Day 1 of all cycles of consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years) |
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| Secondary | Area Under the Plasma Concentration-Time Curve (AUC) of Idasanutlin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; Days 1 and 5 of consolidation Cycle 1; and Days 1 and 5 of maintenance Cycle 1 (1 cycle is 28 days) |
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| Secondary | AUC of Cytarabine | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; and Days 1 and 5 of consolidation Cycle 1 (1 cycle is 28 days) |
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| Secondary | AUC of Daunorubicin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1 (1 cycle is 28 days) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Idasanutlin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; Days 1 and 5 of consolidation Cycle 1; and Days 1 and 5 of maintenance Cycle 1 (1 cycle is 28 days) |
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| Secondary | Cmax of Cytarabine | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; and Days 1 and 5 of consolidation Cycle 1 (1 cycle is 28 days) |
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| Secondary | Cmax of Daunorubicin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1 (1 cycle is 28 days) |
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| Secondary | Total Clearance (CL) of Idasanutlin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; Days 1 and 5 of consolidation Cycle 1; and Days 1 and 5 of maintenance Cycle 1 (1 cycle is 28 days) |
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| Secondary | CL of Cytarabine | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; and Days 1 and 5 of consolidation Cycle 1 (1 cycle is 28 days) |
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| Secondary | CL of Daunorubicin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1 (1 cycle is 28 days) |
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| Secondary | Volume of Distribution at Steady State (Vss) of Idasanutlin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; Days 1 and 5 of consolidation Cycle 1; and Days 1 and 5 of maintenance Cycle 1 (1 cycle is 28 days) |
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| Secondary | Vss of Cytarabine | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; and Days 1 and 5 of consolidation Cycle 1 (1 cycle is 28 days) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Vss of Daunorubicin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1 (1 cycle is 28 days) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Terminal Half-Life (t1/2) of Idasanutlin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; Days 1 and 5 of consolidation Cycle 1; and Days 1 and 5 of maintenance Cycle 1 (1 cycle is 28 days) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | t1/2 of Cytarabine | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; and Days 1 and 5 of consolidation Cycle 1 (1 cycle is 28 days) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | t1/2 of Daunorubicin | The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted | Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected. | Posted | Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1 (1 cycle is 28 days) |
|
From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DOSE ESCALATION COHORT 1 | For induction, participants will be treated with idasanutlin plus cytarabine and daunorubicin. At the investigator's discretion for consolidation, either participants will be treated with idasanutlin and cytarabine or they will undergo Allo-HSCT. For maintenance, participants will be treated with single-agent idasanutlin of 200 mg | 2 | 4 | 3 | 4 | 4 | 4 |
| EG001 | Dose Escalation Cohort 2 | 350 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction | 1 | 9 | 4 | 9 | 9 | 9 |
| EG002 | Dose Escalation Cohort 3 | 250 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction | 0 | 6 | 2 | 6 | 6 | 6 |
| EG003 | POST CONSOLIDATION PHASE COHORT | Participants who are idasanutlin treatment-naive, had received induction and chemotherapy consolidation for AML outside of the study, and were in minimal residual disease (MRD)-positive remission after induction will be enrolled in this cohort to receive maintenance treatment with single-agent idasanutlin of 150 mg | 1 | 4 | 1 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 23.0 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDra 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Ear swelling | Ear and labyrinth disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Papilloedema | Eye disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Change of bowel habit | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Gingival swelling | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hyperchlorhydria | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Oesophagitis haemorrhagic | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Tongue discolouration | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Tongue ulceration | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Catheter site pain | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Catheter site rash | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Generalised oedema | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Physical deconditioning | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Xerosis | General disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Bacillus bacteraemia | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Bacteroides bacteraemia | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Enterocolitis bacterial | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDra 23.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDra 23.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDra 23.0 | Non-systematic Assessment |
| |
| Scrotal injury | Injury, poisoning and procedural complications | MedDra 23.0 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDra 23.0 | Non-systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDra 23.0 | Non-systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDra 23.0 | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| Blood count abnormal | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| Blood lactic acid increased | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| Blood uric acid decreased | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDra 23.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 23.0 | Non-systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Blood blister | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Leukoplakia | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Onychalgia | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Rash morbilliform | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Toxic erythema of chemotherapy | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Transient acantholytic dermatosis | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDra 23.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDra 23.0 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Sep 5, 2021 |
| Prot_SAP_000.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 |
|---|---|
| C586849 | RG7388 |
| D003561 | Cytarabine |
| D003630 | Daunorubicin |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
|
| Post Consolidation Cohort |
150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| Post Consolidation Cohort |
150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| Post Consolidation Cohort |
150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
250 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
250 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
250 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction |
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 |
| Post Consolidation Cohort |
150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 |
| Post Consolidation Cohort |
150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 |
| Post Consolidation Cohort |
150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 |
| Post Consolidation Cohort |
150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 | Post Consolidation Cohort | 150 mg idasanultin day 1 to 5 in maintenance of first remission |
|
| OG003 |
| Post Consolidation Cohort |
150 mg idasanultin day 1 to 5 in maintenance of first remission |
|