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A Phase 1 Dose-Escalation Study of LAM-003 in Patients with Acute Myeloid Leukemia
This clinical trial is a Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of LAM-003 across a range of LAM-003 dose levels when administered to subjects with previously treated relapsed or refractory cute Myeloid Leukemia (AML).
Subjects will self-administer oral LAM-003 either once or twice per day as long as they are safely benefitting from therapy. Cohorts of 3 to 6 subjects will be sequentially enrolled at progressively higher dose levels of LAM-003 using a standard 3+3 dose-escalation design. Based on the pattern of dose-limiting toxicities observed in the first 4 weeks of therapy, escalation will proceed to define a recommended LAM-003 dosing regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAM-003 | Experimental | Open label LAM-003 at three sequentially increasing starting dose levels of 200, 300 and 450 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Label LAM-003 | Drug | LAM-003 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | A primary objective was to determine the LAM-003 MTD and/or recommended dosing regimen (RDR) based on the pattern of dose-limiting toxicities (DLTs) in Cycle 1 of therapy. MTD as determined by DLTs. | At the end of the 28-day observation period for Cycle 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Assessment | Number and percentage of participants with an adverse event (AE). | Weekly during the first 4 weeks and then every 4 weeks for up to 48 weeks. |
| Maximum Plasma Concentration (Cmax) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Langdon Miller, M.D. | AI Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States | ||
| University of Maryland |
Not provided
| Label | URL |
|---|---|
| Trial information can be found on AI Therapeutics website | View source |
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The study included a screening period (up to 28 days) prior to the study drug administration period. Discontinuation of prior antitumor therapy was required except that subjects with rapidly proliferative disease could receive AML cytoreduction with hydroxyurea, cytarabine, and/or cyclophosphamide before the start of LAM-003 and during Cycle 1 of LAM-003 administration.
This study was conducted by 6 investigators located in medical centers throughout the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | LAM-003 200 mg QD | 6 participants were accrued at starting dose level of 200 mg QD. |
| FG001 | LAM-003 300 mg QD | 3 participants were accrued at 300 mg QD. |
| FG002 | LAM-003 450 mg QD | 4 participants were accrued at 450 mg QD. Intrasubject dose escalations were implemented in 1 subject. Subject 006-006 received LAM-003 450 mg QD during Cycles 1 and 2 and received LAM-003 600 mg QD during Cycles 3 and 4. |
| FG003 | LAM-003 600 mg QD | 4 participants were accrued at 600 mg QD. Intrasubject dose escalations were implemented in 2 subjects:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The study population was generally consistent with the epidemiology of AML.
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| ID | Title | Description |
|---|---|---|
| BG000 | LAM-003 200 mg QD | 6 participants were accrued at starting dose level of 200 mg QD. |
| BG001 | LAM-003 300 mg QD | 3 participants were accrued at 300 mg QD. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Maximum Tolerated Dose (MTD) | A primary objective was to determine the LAM-003 MTD and/or recommended dosing regimen (RDR) based on the pattern of dose-limiting toxicities (DLTs) in Cycle 1 of therapy. MTD as determined by DLTs. | Participants were considered evaluable for Cycle 1 DLT assessment if they either had a Cycle 1 DLT or completed 21/28 study drug doses during Cycle 1 and were observed ≥4 weeks from the start of study drug administration without having a DLT. | Posted | Number | DLTs | At the end of the 28-day observation period for Cycle 1. |
|
Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LAM-003 200 mg QD | 6 participants were accrued at starting dose level of 200 mg QD. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease Progression | General disorders | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedma peripheral | General disorders | MedDRA ≥ 19.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Esther Nkrumah | OrphAI Therapeutics | 2675121750 | enkrumah@orphai-therapeutics.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 4, 2019 | Oct 4, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 21, 2020 | Oct 4, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
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Open Label, Dose-Escalation
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The pharmacokinetic parameter Cmax was determined in plasma for the active metabolite of LAM-003A and LAM-003 (prodrug)
| Cycle 1 Days 1, 2 and 8 (1 cycle = 28 days) |
| Time of Maximum Concentration [Tmax] | The pharmacokinetic parameter Tmax was determined in plasma for the active metabolite of LAM-003A and LAM-003 (prodrug) | Cycle 1 Days 1, 2 and 8 (1 cycle = 28 days) |
| Area Under the Curve [AUC] | The pharmacokinetic parameter area under the concentration-time curve was determined in plasma for the active metabolite of LAM-003A and LAM-003 (prodrug). AUClast is the area under the concentration-time curve from time-zero to the time of the last quantifiable concentration. AUCtau is the area under the concentration-time curve during the dosing interval where tau=24hours for once daily (QD) dosing. AUCtau was not calculated for LAM-003. | Cycle 1 Days 1, 2 and 8 (1 cycle = 28 days) |
| Objective Response Rate | Tumor response by AML response criteria (Cheson 2003). | Every 8 to 12 weeks for up to 48 weeks. |
| Event-Free Survival (EFS) and Overall Survival (OS) | Event-free survival (EFS), defined as the interval from the start of study therapy to the earliest of the first documentation of disease relapse, disease progression, treatment failure (TF), or death from any cause. Overall survival (OS), defined as the interval from the start of study therapy to death from any cause. | Every 8 to 12 weeks for up to 48 weeks. |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Hackensack Meridien Health | Hackensack | New Jersey | 07601 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Treatment failure |
|
| Adverse Event |
|
| Withdrawal by Subject |
|
| BG002 | LAM-003 450 mg QD | 4 participants were accrued at 450 mg QD. Intrasubject dose escalations were implemented in 1 subject. Subject 006-006 received LAM-003 450 mg QD during Cycles 1 and 2 and received LAM-003 600 mg QD during Cycles 3 and 4. |
| BG003 | LAM-003 600 mg QD | 4 Participant were accrued at 600 mg QD. Intrasubject dose escalations were implemented in 2 subjects:
|
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Median | Full Range | kg/m^2 |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Count of Participants | Participants |
|
| Elevated peripheral blood AML blast % | Median | Full Range | percentage |
|
| Number of prior anticancer treatment regimens | Median | Full Range | number of treatments |
|
3 participants were accrued at 300 mg QD.
| OG002 | LAM-003 450 mg QD | 4 participants were accrued at 450 mg QD. Intrasubject dose escalations were implemented in 1 subject. Subject 006-006 received LAM-003 450 mg QD during Cycles 1 and 2 and received LAM-003 600 mg QD during Cycles 3 and 4. |
| OG003 | LAM-003 600 mg QD | 4 participants were accrued at 600 mg QD. Intrasubject dose escalations were implemented in 2 subjects:
|
|
|
| Secondary | Adverse Event Assessment | Number and percentage of participants with an adverse event (AE). | All participants who received ≥1 dose of study drug. | Posted | Count of Participants | Participants | Weekly during the first 4 weeks and then every 4 weeks for up to 48 weeks. |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) | The pharmacokinetic parameter Cmax was determined in plasma for the active metabolite of LAM-003A and LAM-003 (prodrug) | The Pharmacokinetic (PK) population included all evaluable participants who were dosed and had sufficient concentration-time data to estimate at least one of the planned PK parameters, as determined by the study pharmacokineticist. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Days 1, 2 and 8 (1 cycle = 28 days) |
|
|
|
| Secondary | Time of Maximum Concentration [Tmax] | The pharmacokinetic parameter Tmax was determined in plasma for the active metabolite of LAM-003A and LAM-003 (prodrug) | The PK population included all evaluable participants who were dosed and had sufficient concentration-time data to estimate at least one of the planned PK parameters, as determined by the study pharmacokineticist. | Posted | Median | Full Range | hours | Cycle 1 Days 1, 2 and 8 (1 cycle = 28 days) |
|
|
|
| Secondary | Area Under the Curve [AUC] | The pharmacokinetic parameter area under the concentration-time curve was determined in plasma for the active metabolite of LAM-003A and LAM-003 (prodrug). AUClast is the area under the concentration-time curve from time-zero to the time of the last quantifiable concentration. AUCtau is the area under the concentration-time curve during the dosing interval where tau=24hours for once daily (QD) dosing. AUCtau was not calculated for LAM-003. | The PK population included all evaluable participants who were dosed and had sufficient concentration-time data to estimate at least one of the planned PK parameters, as determined by the study pharmacokineticist. | Posted | Mean | Standard Deviation | h*ng/mL | Cycle 1 Days 1, 2 and 8 (1 cycle = 28 days) |
|
|
|
| Secondary | Objective Response Rate | Tumor response by AML response criteria (Cheson 2003). | All participants who received ≥1 dose of study drug. | Posted | Count of Participants | Participants | Every 8 to 12 weeks for up to 48 weeks. |
|
|
|
| Secondary | Event-Free Survival (EFS) and Overall Survival (OS) | Event-free survival (EFS), defined as the interval from the start of study therapy to the earliest of the first documentation of disease relapse, disease progression, treatment failure (TF), or death from any cause. Overall survival (OS), defined as the interval from the start of study therapy to death from any cause. | All participants who received ≥1 dose of study drug. | Posted | Median | Full Range | months | Every 8 to 12 weeks for up to 48 weeks. |
|
|
|
| 2 |
| 6 |
| 3 |
| 6 |
| 6 |
| 6 |
| EG001 | LAM-003 300 mg QD | 3 participants were accrued at 300 mg QD. | 1 | 3 | 3 | 3 | 3 | 3 |
| EG002 | LAM-003 450 mg QD | 4 participants were accrued at 450 mg QD. | 2 | 4 | 3 | 4 | 4 | 4 |
| EG003 | LAM-003 600 mg QD | 4 participants were accrued at 600 mg QD. | 1 | 4 | 2 | 4 | 4 | 4 |
| EG004 | LAM-003 750 mg QD | 3 participants received 750 mg QD after intrasubject dose escalations. • Subject 006-006 received LAM-003 450 mg QD during Cycles 1, 600 mg LAM-003 in Cycle 2 and received LAM-003 750 mg QD during Cycles 3 and 4. Subject 005-011 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycles 2 and 3. • Subject 006-007 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycle 2. | 2 | 3 | 2 | 3 | 3 | 3 |
| Pyrexia | General disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Hemoglobin Decreased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| WBC Count Increased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Cerebral Hemorrhage | Nervous system disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Hemorrhage Intracranial | Nervous system disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Hemoglobin decreased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Tropoin T increased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Plural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Decreased appetitie | Metabolism and nutrition disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Anal abcess | Infections and infestations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Allergic transfusion reaction | Injury, poisoning and procedural complications | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Hypobarism | Injury, poisoning and procedural complications | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Eyelid pain | Eye disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Leukaemia cutis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
| Scrotal irritation | Reproductive system and breast disorders | MedDRA ≥ 19.1 | Systematic Assessment |
|
Not provided
| D006425 |
| Hemic and Lymphatic Diseases |
| With ≥1 TEAE |
|
| With ≥1 study-drug-related TEAE |
|
| With ≥1 TEAE of Grade ≥3 |
|
| With ≥1 study-drug-related TEAE of Grade ≥3 |
|
| With ≥1 SAE |
|
| With ≥1 treatment-emergent SAE |
|
| With ≥1 study-drug-related treatment-emergent SAE |
|
| With ≥1 AESI |
|
| With AEs resulting in drug interruption of study drug |
|
| With AEs (other than AML progression) resulting in permanent discontinuation of study drug |
|
| With AEs resulting in death within 30 days from the last dose of study drug |
|
|
| LAM-003A Day 8 |
|
|
| LAM-003 Day 1 |
|
|
| LAM-003 Day 8 |
|
|
|
| LAM-003A for Day 8 |
|
|
| LAM-003 for Day 1 |
|
|
| LAM-003 for Day 8 |
|
|
|
| LAM-003A AUClast for Day 8 |
|
|
| LAM-003 AUClast for Day 1 |
|
|
| LAM-003 AUClast for Day 8 |
|
|
| LAM-003A AUCtau for Day 1 |
|
|
| LAM-003A AUCtau for Day 8 |
|
|
| Partial Response |
|
| Treatment Failure |
|
| Disease Relapse or Progression |
|
| Nonevaluable |
|
| OS |
|