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Sponsor decision, unrelated to safety
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The main objective is to assess the safety, tolerability, and efficacy of AMG 176 as monotherapy and in combination with the 7-day regimen of azacitidine for the treatment of Higher-Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia (HR-MDS/CMML).
This study is a Phase 1 clinical trial designed to assess the safety, tolerability, and efficacy of AMG 176 as monotherapy and in combination with the 7-day regimen of azacitidine for the treatment of HR-MDS/CMML. Participants will be treated with intravenous (IV) AMG 176 and IV or subcutaneous (SC) azacitidine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A - AMG 176 Monotherapy (Dose Exploration) | Experimental | Two dose levels of AMG 176 will be tested in Part 1A to find the optimal biological dose/minimum safe biologically effective dose (OBD/MSBED). |
|
| Part 1B - AMG 176 and Azacitidine Combination Therapy (Dose Exploration) | Experimental | After the OBD is found in Part 1A, two dose levels of AMG 176 in combination with azacitidine will be tested in Part 1B to find the OBD/MSBED. |
|
| Part 2 - AMG 176 and Azacitidine Combination Therapy (Dose Expansion) | Experimental | After the completion of Part 1, the Part 2 dose expansion phase will begin at the OBD/MSBED identified in Part 1. Venetoclax-naïve and venetoclax-exposed R/R HR-MDS participants after HMA failure will be enrolled along with participants with newly diagnosed HR-MDS/CMML. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 176 | Drug | Administered as an intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and included the below if considered by the investigator to be related to AMG 176: Grade 3 or higher non-hematological or a Grade 4 hematologic adverse event (AE) during the DLT observation period in Part 1. CTCAE Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, and Grade 5 results in death. | Day 1 to day 28 of cycle 1 (each cycle was 28 days) |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a clinical trial participants. TEAEs were any AE that started on or after receiving the first dose of investigational product and up to 28 days after the last dose of investigational product or the end of study date, whichever is earlier. Treatment-related TEAEs were those considered possibly related to study treatment by the investigator. Any clinically significant changes in electrocardiograms, vital signs, and clinical laboratory tests were recorded as TEAEs. A serious TEAE resulted in death, was immediately life threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event. | Day 1 cycle 1 to 30 days after the last dose of AMG 176 or end of study, whichever occurred earlier (cycle length = 28 days). Median treatment duration was 2.7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Response According to the Uniform Response Criteria for MDS/Myeloproliferative Neoplasm (MPN) | A responder was assessed as having complete remission (CR) or partial remission (PR). Non-responders had stable disease, progressive disease or were not evaluable. CR: ≤ 5% myeloblasts with normal maturation of all cell lines and return to normal cellularity; osteomyelofibrosis was absent or equal to mild reticulin fibrosis; resolution of extramedullary disease present before therapy. PR: normalization of peripheral counts and hepatosplenomegaly with bone marrow blasts reduced by 50% but >5% of cellularity except in cases of MDS/MPN with ≤ 5% blasts at baseline. Progression: ≥ 50% reduction from maximum response levels in granulocytes or platelets, and/or reduction in hemoglobin by ≥ 1.5 g/dL in the absence of another explanation; transfusion dependence. |
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Inclusion Criteria:
Age >= 18 years of age
For Part 1, participants have R/R MDS post-HMA failure, defined as prior receipt of 4 cycles of HMA therapy (including but not limited to decitabine, azacitidine, investigational HMAs such as SGI-110, and oral HMAs such as oral decitabine and cedazuridine [ASTX727] and oral azacitidine [CC-486]) with failure to attain a response or progression of disease or relapse at any time after prior response to HMA therapy
a. Note: participants with HR-CMML (CMML-1 or 2 by World Health Organization [WHO]) are eligible. Hydroxyurea administration will be allowed on the study to lower the white cell count to <= 10 000/μL prior to the initiation of therapy
For Part 2, participants will be divided into 2 cohorts:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
The study was planned to be conducted in 3 parts and was discontinued early after the completion of Part 1A (dose exploration). Part 1B (dose escalation/de-escalation) and Part 3 (dose expansion) were not conducted and did not enroll any participants. Dose level 1 is a low dose and Dose level 2 is a high dose.
A total of 7 participants with higher risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia were enrolled at a single study center in the United States from November 2022 and the last participant's last visit was in December 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1A Dose Exploration: AMG 176 Dose Level 1 | Participants received intravenous (IV) AMG 176 at dose level 1 once a week in 28-day cycles. Treatment was planned until disease progression or unacceptable toxicity. |
| FG001 | Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2 | Participants received IV AMG 176 at dose level 1 on cycle 1 day 1 and then dose level 2 from cycle 1 day 8 and once a week thereafter (each cycle = 28 days). Treatment was planned until disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1A Dose Exploration: AMG 176 Dose Level 1 | Participants received IV AMG 176 at dose level 1 once a week in 28-day cycles. Treatment was planned until disease progression or unacceptable toxicity. |
| BG001 | Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and included the below if considered by the investigator to be related to AMG 176: Grade 3 or higher non-hematological or a Grade 4 hematologic adverse event (AE) during the DLT observation period in Part 1. CTCAE Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, and Grade 5 results in death. | DLT-evaluable participants were those who experienced a DLT during the DLT evaluation period or if they received 75% of the planned doses of AMG 176 and completed the DLT evaluation period. | Posted | Count of Participants | Participants | Day 1 to day 28 of cycle 1 (each cycle was 28 days) |
|
For all-cause mortality, from enrollment through end of study; median (min, max) time on study was 4.1 ( 2.2, 8.61) months. For serious and other AEs, from first dose of AMG 176 to up to 30 days after the last dose or end of study, whichever occurred first; median (min, max) duration was 2.7 ( 2.07, 4.73) months.
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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 | Part 1A Dose Exploration: AMG 176 Dose Level 1 | Participants received IV AMG 176 at dose level 1 once a week in 28-day cycles. Treatment was planned until disease progression or unacceptable toxicity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular arrhythmia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
The study was planned to be conducted in 3 parts and was discontinued early after the completion of Part 1A due to strategic reasons. No participants enrolled into Parts 1B and 2.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.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 | Apr 28, 2022 | May 22, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 10, 2024 | May 22, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000720001 | tapotoclax |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Azacitidine | Drug | Administered as an IV infusion or subcutaneous (SC) injection. |
|
| Cycle 1 to disease progression or end of study, whichever occurred earlier (cycle length = 28 days). Median time on study was 4.1 months |
| Time to a Response According to the Uniform Response Criteria for MDS/MPN | A responder was assessed as having CR or PR. CR: ≤ 5% myeloblasts with normal maturation of all cell lines and return to normal cellularity; osteomyelofibrosis was absent or equal to mild reticulin fibrosis; resolution of extramedullary disease present before therapy. PR: normalization of peripheral counts and hepatosplenomegaly with bone marrow blasts reduced by 50% but >5% of cellularity except in cases of MDS/MPN with ≤ 5% blasts at baseline. | Cycle 1 to disease progression or end of study, whichever occurred earlier (cycle length = 28 days). Median time on study was 4.1 months |
| Duration of Response According to the Uniform Response Criteria for MDS/MPN | A responder was assessed as having CR or PR. CR: ≤ 5% myeloblasts with normal maturation of all cell lines and return to normal cellularity; osteomyelofibrosis was absent or equal to mild reticulin fibrosis; resolution of extramedullary disease present before therapy. PR: normalization of peripheral counts and hepatosplenomegaly with bone marrow blasts reduced by 50% but >5% of cellularity except in cases of MDS/MPN with ≤ 5% blasts at baseline. | Cycle 1 to disease progression or end of study, whichever occurred earlier (cycle length = 28 days). Median time on study was 4.1 months |
| Event-free Survival | Cycle 1 to disease progression or end of study, whichever occurred earlier (cycle length = 28 days). Median time on study was 4.1 months |
| Maximum Plasma Concentration (Cmax) of AMG 176 | AMG 176 plasma concentrations with values below the limit of quantification were set to zero. Pharmacokinetic (PK) parameters were determined from the time concentration profile using noncompartmental analysis. | Cycle 1: pre-dose, end of infusion (EOI), 3, 5, 7, 8, 24 hours post-infusion in weeks 1 and 2; pre-dose, EOI, 8 and 24 hours post-infusion in cycle 1 weeks 3 and 4 |
| Time to Cmax (Tmax) of AMG 176 | AMG 176 plasma concentrations with values below the limit of quantification were set to zero. PK parameters were determined from the time concentration profile using noncompartmental analysis. | Cycle 1: pre-dose, EOI, 3, 5, 7, 8, 24 hours post-infusion in weeks 1 and 2; pre-dose, EOI, 8 and 24 hours post-infusion in cycle 1 weeks 3 and 4 |
| Area Under the Plasma Concentration Time Curve From 0 to 168 Hours (AUC168hr) of AMG 176 | AMG 176 plasma concentrations with values below the limit of quantification were set to zero. PK parameters were determined from the time concentration profile using noncompartmental analysis. | Cycle 1: pre-dose, EOI, 3, 5, 7, 8, 24 hours post-infusion in weeks 1 and 2; pre-dose, EOI, 8 and 24 hours post-infusion in cycle 1 weeks 3 and 4 |
| Terminal Half-life of AMG 176 | AMG 176 plasma concentrations with values below the limit of quantification were set to zero. PK parameters were determined from the time concentration profile using noncompartmental analysis. | Cycle 1: pre-dose, EOI, 3, 5, 7, 8, 24 hours post-infusion in weeks 1 and 2; pre-dose, EOI, 8 and 24 hours post-infusion in cycle 1 weeks 3 and 4 |
| Clearance (CL) of AMG 176 | AMG 176 plasma concentrations with values below the limit of quantification were set to zero. PK parameters were determined from the time concentration profile using noncompartmental analysis. | Cycle 1: pre-dose, EOI, 3, 5, 7, 8, 24 hours post-infusion in weeks 1 and 2; pre-dose, EOI, 8 and 24 hours post-infusion in cycle 1 weeks 3 and 4 |
Participants received IV AMG 176 at dose level 1 on cycle 1 day 1 and then dose level 2 from cycle 1 day 8 and once a week thereafter (each cycle = 28 days). Treatment was planned until disease progression or unacceptable toxicity. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2 | Participants received IV AMG 176 at dose level 1 on cycle 1 day 1 and then dose level 2 from cycle 1 day 8 and once a week thereafter (each cycle = 28 days). Treatment was planned until disease progression or unacceptable toxicity. |
|
|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a clinical trial participants. TEAEs were any AE that started on or after receiving the first dose of investigational product and up to 28 days after the last dose of investigational product or the end of study date, whichever is earlier. Treatment-related TEAEs were those considered possibly related to study treatment by the investigator. Any clinically significant changes in electrocardiograms, vital signs, and clinical laboratory tests were recorded as TEAEs. A serious TEAE resulted in death, was immediately life threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event. | The full analysis set included all enrolled participants who received at least 1 dose of AMG 176. | Posted | Count of Participants | Participants | Day 1 cycle 1 to 30 days after the last dose of AMG 176 or end of study, whichever occurred earlier (cycle length = 28 days). Median treatment duration was 2.7 months |
|
|
|
| Secondary | Number of Participants With a Response According to the Uniform Response Criteria for MDS/Myeloproliferative Neoplasm (MPN) | A responder was assessed as having complete remission (CR) or partial remission (PR). Non-responders had stable disease, progressive disease or were not evaluable. CR: ≤ 5% myeloblasts with normal maturation of all cell lines and return to normal cellularity; osteomyelofibrosis was absent or equal to mild reticulin fibrosis; resolution of extramedullary disease present before therapy. PR: normalization of peripheral counts and hepatosplenomegaly with bone marrow blasts reduced by 50% but >5% of cellularity except in cases of MDS/MPN with ≤ 5% blasts at baseline. Progression: ≥ 50% reduction from maximum response levels in granulocytes or platelets, and/or reduction in hemoglobin by ≥ 1.5 g/dL in the absence of another explanation; transfusion dependence. | The full analysis set included all enrolled participants who received at least 1 dose of AMG 176. | Posted | Count of Participants | Participants | Cycle 1 to disease progression or end of study, whichever occurred earlier (cycle length = 28 days). Median time on study was 4.1 months |
|
|
|
| Secondary | Time to a Response According to the Uniform Response Criteria for MDS/MPN | A responder was assessed as having CR or PR. CR: ≤ 5% myeloblasts with normal maturation of all cell lines and return to normal cellularity; osteomyelofibrosis was absent or equal to mild reticulin fibrosis; resolution of extramedullary disease present before therapy. PR: normalization of peripheral counts and hepatosplenomegaly with bone marrow blasts reduced by 50% but >5% of cellularity except in cases of MDS/MPN with ≤ 5% blasts at baseline. | The full analysis set included all enrolled participants who received at least 1 dose of AMG 176. No participants were responders. | Posted | Cycle 1 to disease progression or end of study, whichever occurred earlier (cycle length = 28 days). Median time on study was 4.1 months |
|
|
| Secondary | Duration of Response According to the Uniform Response Criteria for MDS/MPN | A responder was assessed as having CR or PR. CR: ≤ 5% myeloblasts with normal maturation of all cell lines and return to normal cellularity; osteomyelofibrosis was absent or equal to mild reticulin fibrosis; resolution of extramedullary disease present before therapy. PR: normalization of peripheral counts and hepatosplenomegaly with bone marrow blasts reduced by 50% but >5% of cellularity except in cases of MDS/MPN with ≤ 5% blasts at baseline. | The full analysis set included all enrolled participants who received at least 1 dose of AMG 176. No participants were responders. | Posted | Cycle 1 to disease progression or end of study, whichever occurred earlier (cycle length = 28 days). Median time on study was 4.1 months |
|
|
| Secondary | Event-free Survival | As pre-specified in Section 10 of the statistical analysis plan, EFS was not analyzed. | Posted | Cycle 1 to disease progression or end of study, whichever occurred earlier (cycle length = 28 days). Median time on study was 4.1 months |
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of AMG 176 | AMG 176 plasma concentrations with values below the limit of quantification were set to zero. Pharmacokinetic (PK) parameters were determined from the time concentration profile using noncompartmental analysis. | The PK analysis set included all participants who received at least 1 dose of AMG 176 and had at least 1 PK sample collected. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1: pre-dose, end of infusion (EOI), 3, 5, 7, 8, 24 hours post-infusion in weeks 1 and 2; pre-dose, EOI, 8 and 24 hours post-infusion in cycle 1 weeks 3 and 4 |
|
|
|
| Secondary | Time to Cmax (Tmax) of AMG 176 | AMG 176 plasma concentrations with values below the limit of quantification were set to zero. PK parameters were determined from the time concentration profile using noncompartmental analysis. | The PK analysis set included all participants who received at least 1 dose of AMG 176 and had at least 1 PK sample collected. | Posted | Median | Full Range | hours | Cycle 1: pre-dose, EOI, 3, 5, 7, 8, 24 hours post-infusion in weeks 1 and 2; pre-dose, EOI, 8 and 24 hours post-infusion in cycle 1 weeks 3 and 4 |
|
|
|
| Secondary | Area Under the Plasma Concentration Time Curve From 0 to 168 Hours (AUC168hr) of AMG 176 | AMG 176 plasma concentrations with values below the limit of quantification were set to zero. PK parameters were determined from the time concentration profile using noncompartmental analysis. | The PK analysis set included all participants who received at least 1 dose of AMG 176 and had at least 1 PK sample collected. Participants with data available at each time point are included. | Posted | Mean | Standard Deviation | hour*ng/mL | Cycle 1: pre-dose, EOI, 3, 5, 7, 8, 24 hours post-infusion in weeks 1 and 2; pre-dose, EOI, 8 and 24 hours post-infusion in cycle 1 weeks 3 and 4 |
|
|
|
| Secondary | Terminal Half-life of AMG 176 | AMG 176 plasma concentrations with values below the limit of quantification were set to zero. PK parameters were determined from the time concentration profile using noncompartmental analysis. | The PK analysis set included all participants who received at least 1 dose of AMG 176 and had at least 1 PK sample collected. Participants with data available at each time point are included. | Posted | Median | Full Range | hours | Cycle 1: pre-dose, EOI, 3, 5, 7, 8, 24 hours post-infusion in weeks 1 and 2; pre-dose, EOI, 8 and 24 hours post-infusion in cycle 1 weeks 3 and 4 |
|
|
|
| Secondary | Clearance (CL) of AMG 176 | AMG 176 plasma concentrations with values below the limit of quantification were set to zero. PK parameters were determined from the time concentration profile using noncompartmental analysis. | The PK analysis set included all participants who received at least 1 dose of AMG 176 and had at least 1 PK sample collected. Participants with data available at each time point are included. | Posted | Mean | Standard Deviation | mL/hour/m^2 | Cycle 1: pre-dose, EOI, 3, 5, 7, 8, 24 hours post-infusion in weeks 1 and 2; pre-dose, EOI, 8 and 24 hours post-infusion in cycle 1 weeks 3 and 4 |
|
|
|
| 3 |
| 4 |
| 3 |
| 4 |
| 4 |
| 4 |
| EG001 | Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2 | Participants received IV AMG 176 at dose level 1 on cycle 1 day 1 and then dose level 2 from cycle 1 day 8 and once a week thereafter (each cycle = 28 days). Treatment was planned until disease progression or unacceptable toxicity. | 1 | 3 | 2 | 3 | 3 | 3 |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Penile infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Catheter site pruritus | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Facial pain | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hepatic lesion | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Malignant peritoneal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
|
| Genital ulceration | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
|
| Scrotal erythema | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
|
| Testicular haemorrhage | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D054437 |
| Myelodysplastic-Myeloproliferative Diseases |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| Cycle 1 day 8 |
|
|
| Cycle 1 day 8 |
|
|
| Cycle 1 day 8 |
|
|