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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02675452




Registration number
NCT02675452
Ethics application status
Date submitted
22/12/2015
Date registered
5/02/2016
Date last updated
29/10/2024

Titles & IDs
Public title
AMG 176 First in Human Trial in Participants With Relapsed or Refractory Multiple Myeloma and Participants With Relapsed or Refractory Acute Myeloid Leukemia
Scientific title
A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 176 in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Secondary ID [1] 0 0
2015-004777-32
Secondary ID [2] 0 0
20150161
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma 0 0
Relapsed or Refractory Acute Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 176
Treatment: Drugs - Azacitidine
Treatment: Drugs - Itraconazole

Experimental: AMG 176 - Part 1a - Part 1a - Participants with muliple myeloma (MM) administered AMG 176 as an intravenous (IV) infusion for two-consecutive days (QD2) followed by a 5 days break.

Experimental: AMG 176 - Part 1b - Part 1b - Participants with multiple myeloma (MM) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break.

Experimental: AMG 176 - Part 3a - Part 3a - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion once a day, for two-consecutive days (QD2) followed by a 5 day break.

Experimental: AMG 176 - Part 3b - Part 3b - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break.

Experimental: AMG 176 - Part 3c - Part 3c - Participants in Japan only with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break.

Experimental: AMG 176 - Part 3d - Part 3d - Participants in the United States with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW), for 3 weeks, in combination with itraconazole.

Experimental: AMG 176 - Part 4 - Part 4 - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, either once a week (QW) followed by 6 days break, or once a day, for two-consecutive days (QD2), in combination with azacitidine.

Experimental: AMG 176 - Part 5 - Part 5 - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion at the maximum tolerated combination dose from Part 4, either once a week (QW) followed by 6 days break, or once a day, for two-consecutive days (QD2), in combination with azacitidine.


Treatment: Drugs: AMG 176
Study Drug

Treatment: Drugs: Azacitidine
Non-investigational product

Treatment: Drugs: Itraconazole
Non-investigational product

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Multiple Myeloma (MM) Part 1a Incidence of dose-limiting toxicities (DLTs)
Timepoint [1] 0 0
Up to 6 months
Primary outcome [2] 0 0
MM Part 1a Incidence of treatment-related adverse events
Timepoint [2] 0 0
Up to 18 months
Primary outcome [3] 0 0
MM Part 1a Incidence of treatment-emergent adverse events
Timepoint [3] 0 0
Up to 18 months
Primary outcome [4] 0 0
MM Part 1a Incidence of clinically significant changes in vital signs
Timepoint [4] 0 0
Up to 6 months
Primary outcome [5] 0 0
MM Part 1a Incidence of clinically significant changes in electrocardiograms (ECGs)
Timepoint [5] 0 0
Up to 6 months
Primary outcome [6] 0 0
MM Part 1a Incidence of clinically significant changes in clinical laboratory tests
Timepoint [6] 0 0
Up to 6 months
Primary outcome [7] 0 0
MM Part 1a Pharmacokinetic (PK) parameters for AMG 176: maximum observed concentration (Cmax)
Timepoint [7] 0 0
1 month on treatment
Primary outcome [8] 0 0
MM Part 1a Pharmacokinetic parameters for AMG 176: area under the concentration-time curve (AUC)
Timepoint [8] 0 0
1 month on treatment
Primary outcome [9] 0 0
MM Part 1a Pharmacokinetic parameters for AMG 176: clearance (CL)
Timepoint [9] 0 0
1 month on treatment
Primary outcome [10] 0 0
MM Part 1a Pharmacokinetic parameters for AMG 176: half-life (t1/2)
Timepoint [10] 0 0
1 month on treatment
Primary outcome [11] 0 0
MM Part 1b Incidence of DLTs
Timepoint [11] 0 0
Up to 6 months
Primary outcome [12] 0 0
MM Part 1b Incidence of treatment-related adverse events
Timepoint [12] 0 0
Up to 18 months
Primary outcome [13] 0 0
MM Part 1b Incidence of treatment-emergent adverse events
Timepoint [13] 0 0
Up to 18 months
Primary outcome [14] 0 0
MM Part 1b Incidence of clinically significant changes in vital signs
Timepoint [14] 0 0
Up to 6 months
Primary outcome [15] 0 0
MM Part 1b Incidence of clinically significant changes in ECGs
Timepoint [15] 0 0
Up to 6 months
Primary outcome [16] 0 0
MM Part 1b Incidence of clinically significant changes in clinical laboratory tests
Timepoint [16] 0 0
Up to 6 months
Primary outcome [17] 0 0
MM Part 1b Pharmacokinetic parameters for AMG 176: Cmax
Timepoint [17] 0 0
1 month on treatment
Primary outcome [18] 0 0
MM Part 1b Pharmacokinetic parameters for AMG 176: AUC
Timepoint [18] 0 0
1 month on treatment
Primary outcome [19] 0 0
MM Part 1b Pharmacokinetic parameters for AMG 176: CL
Timepoint [19] 0 0
1 month on treatment
Primary outcome [20] 0 0
MM Part 1b Pharmacokinetic parameters for AMG 176: t1/2
Timepoint [20] 0 0
1 month on treatment
Primary outcome [21] 0 0
Acute Myeloid Leukemia (AML) Part 3a Incidence of DLTs
Timepoint [21] 0 0
Up to 6 months
Primary outcome [22] 0 0
AML Part 3a Incidence of treatment-related adverse events
Timepoint [22] 0 0
Up to 18 months
Primary outcome [23] 0 0
AML Part 3a Incidence of treatment-emergent adverse events
Timepoint [23] 0 0
Up to 18 months
Primary outcome [24] 0 0
AML Part 3a Incidence of clinically significant changes in vital signs
Timepoint [24] 0 0
Up to 6 months
Primary outcome [25] 0 0
AML Part 3a Incidence of clinically significant changes in ECGs
Timepoint [25] 0 0
Up to 6 months
Primary outcome [26] 0 0
AML Part 3a Incidence of clinically significant changes in clinical laboratory tests
Timepoint [26] 0 0
Up to 6 months
Primary outcome [27] 0 0
AML Part 3a Pharmacokinetic parameters for AMG 176: Cmax
Timepoint [27] 0 0
1 month on treatment
Primary outcome [28] 0 0
AML Part 3a Pharmacokinetic parameters for AMG 176: AUC
Timepoint [28] 0 0
1 month on treatment
Primary outcome [29] 0 0
AML Part 3a Pharmacokinetic parameters for AMG 176: CL
Timepoint [29] 0 0
1 month on treatment
Primary outcome [30] 0 0
AML Part 3a Pharmacokinetic parameters for AMG 176: t1/2
Timepoint [30] 0 0
1 month on treatment
Primary outcome [31] 0 0
AML Part 3b Incidence of DLTs
Timepoint [31] 0 0
Up to 6 months
Primary outcome [32] 0 0
AML Part 3b Incidence of treatment-related adverse events
Timepoint [32] 0 0
Up to 18 months
Primary outcome [33] 0 0
AML Part 3b Incidence of treatment-emergent adverse events
Timepoint [33] 0 0
Up to 18 months
Primary outcome [34] 0 0
AML Part 3b Incidence of clinically significant changes in vital signs
Timepoint [34] 0 0
Up to 6 months
Primary outcome [35] 0 0
AML Part 3b Incidence of clinically significant changes in ECGs
Timepoint [35] 0 0
Up to 6 months
Primary outcome [36] 0 0
AML Part 3b Incidence of clinically significant changes in clinical laboratory tests
Timepoint [36] 0 0
Up to 6 months
Primary outcome [37] 0 0
AML Part 3b Pharmacokinetic parameters for AMG 176: Cmax
Timepoint [37] 0 0
1 month on treatment
Primary outcome [38] 0 0
AML Part 3b Pharmacokinetic parameters for AMG 176: AUC
Timepoint [38] 0 0
1 month on treatment
Primary outcome [39] 0 0
AML Part 3b Pharmacokinetic parameters for AMG 176: CL
Timepoint [39] 0 0
1 month on treatment
Primary outcome [40] 0 0
AML Part 3b Pharmacokinetic parameters for AMG 176: t1/2
Timepoint [40] 0 0
1 month on treatment
Primary outcome [41] 0 0
AML Part 3c Incidence of DLTs
Timepoint [41] 0 0
Up to 6 months
Primary outcome [42] 0 0
AML Part 3c Incidence of treatment-related adverse events
Timepoint [42] 0 0
Up to 18 months
Primary outcome [43] 0 0
AML Part 3c Incidence of treatment-emergent adverse events
Timepoint [43] 0 0
Up to 18 months
Primary outcome [44] 0 0
AML Part 3c Incidence of clinically significant changes in vital signs
Timepoint [44] 0 0
Up to 6 months
Primary outcome [45] 0 0
AML Part 3c Incidence of clinically significant changes in ECGs
Timepoint [45] 0 0
Up to 6 months
Primary outcome [46] 0 0
AML Part 3c Incidence of clinically significant changes in clinical laboratory tests
Timepoint [46] 0 0
Up to 6 months
Primary outcome [47] 0 0
AML Part 3c Pharmacokinetic parameters for AMG 176: Cmax
Timepoint [47] 0 0
1 month on treatment
Primary outcome [48] 0 0
AML Part 3c Pharmacokinetic parameters for AMG 176: AUC
Timepoint [48] 0 0
1 month on treatment
Primary outcome [49] 0 0
AML Part 3c Pharmacokinetic parameters for AMG 176: CL
Timepoint [49] 0 0
1 month on treatment
Primary outcome [50] 0 0
AML Part 3c Pharmacokinetic parameters for AMG 176: t1/2
Timepoint [50] 0 0
1 month on treatment
Primary outcome [51] 0 0
AML Part 3d Pharmacokinetic parameters for AMG 176 and itraconazole: Cmax
Timepoint [51] 0 0
3 weeks on treatment
Primary outcome [52] 0 0
AML Part 3d Pharmacokinetic parameters for AMG 176 and itraconazole: AUC
Timepoint [52] 0 0
3 weeks on treatment
Primary outcome [53] 0 0
AML Part 3d Pharmacokinetic parameters for AMG 176 and itraconazole: CL
Timepoint [53] 0 0
3 weeks on treatment
Primary outcome [54] 0 0
AML Part 3d Pharmacokinetic parameters for AMG 176 and itraconazole: t1/2
Timepoint [54] 0 0
3 weeks on treatment
Primary outcome [55] 0 0
AML Part 4 Incidence of DLTs
Timepoint [55] 0 0
Up to 6 months
Primary outcome [56] 0 0
AML Part 4 Incidence of treatment-related adverse events
Timepoint [56] 0 0
Up to 18 months
Primary outcome [57] 0 0
AML Part 4 Incidence of treatment-emergent adverse events
Timepoint [57] 0 0
Up to 18 months
Primary outcome [58] 0 0
AML Part 4 Incidence of clinically significant changes in vital signs
Timepoint [58] 0 0
Up to 6 months
Primary outcome [59] 0 0
AML Part 4 Incidence of clinically significant changes in ECGs
Timepoint [59] 0 0
Up to 6 months
Primary outcome [60] 0 0
AML Part 4 Incidence of clinically significant changes in clinical laboratory tests
Timepoint [60] 0 0
Up to 6 months
Primary outcome [61] 0 0
AML Part 4 Pharmacokinetic parameters for AMG 176 and azacitidine: Cmax
Timepoint [61] 0 0
1 month on treatment
Primary outcome [62] 0 0
AML Part 4 Pharmacokinetic parameters for AMG 176 and azacitidine: AUC
Timepoint [62] 0 0
1 month on treatment
Primary outcome [63] 0 0
AML Part 4 Pharmacokinetic parameters for AMG 176 and azacitidine: CL
Timepoint [63] 0 0
1 month on treatment
Primary outcome [64] 0 0
AML Part 4 Pharmacokinetic parameters for AMG 176 and azacitidine: t1/2
Timepoint [64] 0 0
1 month on treatment
Primary outcome [65] 0 0
AML Part 5 Incidence of treatment-related adverse events
Timepoint [65] 0 0
Up to 18 months
Primary outcome [66] 0 0
AML Part 5 Incidence of treatment-emergent adverse events
Timepoint [66] 0 0
Up to 18 months
Primary outcome [67] 0 0
AML Part 5 Incidence of clinically significant changes in vital signs
Timepoint [67] 0 0
Up to 6 months
Primary outcome [68] 0 0
AML Part 5 Incidence of clinically significant changes in ECGs
Timepoint [68] 0 0
Up to 6 months
Primary outcome [69] 0 0
AML Part 5 Incidence of clinically significant changes in clinical laboratory tests
Timepoint [69] 0 0
Up to 6 months
Primary outcome [70] 0 0
AML Part 5 Pharmacokinetic parameters for AMG 176 and azacitidine: Cmax
Timepoint [70] 0 0
1 month on treatment
Primary outcome [71] 0 0
AML Part 5 Pharmacokinetic parameters for AMG 176 and azacitidine: AUC
Timepoint [71] 0 0
1 month on treatment
Primary outcome [72] 0 0
AML Part 5 Pharmacokinetic parameters for AMG 176 and azacitidine: CL
Timepoint [72] 0 0
1 month on treatment
Primary outcome [73] 0 0
AML Part 5 Pharmacokinetic parameters for AMG 176 and azacitidine: t1/2
Timepoint [73] 0 0
1 month on treatment
Secondary outcome [1] 0 0
MM Part 1a Overall response (OR) according to International Myeloma Working Group uniform response criteria (IMWG-URC) for MM subjects
Timepoint [1] 0 0
6 months on treatment
Secondary outcome [2] 0 0
MM Part 1a Progression-free survival (PFS)
Timepoint [2] 0 0
6 months on treatment
Secondary outcome [3] 0 0
MM Part 1a Time to response
Timepoint [3] 0 0
6 months on treatment
Secondary outcome [4] 0 0
MM Part 1a Duration of response (DOR)
Timepoint [4] 0 0
6 months on treatment
Secondary outcome [5] 0 0
MM Part 1a BAX and caspase 3 expression in circulating monocytes and /or circulating monocyte counts
Timepoint [5] 0 0
6 months on treatment
Secondary outcome [6] 0 0
MM Part 1b BAX and caspase 3 expression in circulating monocytes and/or circulating monocyte counts
Timepoint [6] 0 0
6 months on treatment
Secondary outcome [7] 0 0
MM Part 1b Overall response (OR) according to IMWG-URC for MM subjects
Timepoint [7] 0 0
6 months on treatment
Secondary outcome [8] 0 0
MM Part 1b Progression free survival (PFS)
Timepoint [8] 0 0
6 months on treatment
Secondary outcome [9] 0 0
MM Part 1b Time to response
Timepoint [9] 0 0
6 months on treatment
Secondary outcome [10] 0 0
MM Part 1b Duration of response (DOR)
Timepoint [10] 0 0
6 months on treatment
Secondary outcome [11] 0 0
AML Part 3a, 3b and 3c Overall response (OR) according to the 2017 European Leukemia Net (ELN) criteria (Döhner et al, 2017)
Timepoint [11] 0 0
6 months on treatment
Secondary outcome [12] 0 0
AML Part 3a, 3b and 3c Event free survival (EFS)
Timepoint [12] 0 0
6 months on treatment
Secondary outcome [13] 0 0
AML Part 3a, 3b and 3c Time to response
Timepoint [13] 0 0
6 months on treatment
Secondary outcome [14] 0 0
AML Part 3a, 3b and 3c Duration of response (DOR)
Timepoint [14] 0 0
6 months on treatment
Secondary outcome [15] 0 0
AML Part 3d Incidence of treatment-emergent adverse events
Timepoint [15] 0 0
3 weeks on treatment
Secondary outcome [16] 0 0
AML Part 3d Incidence of clinically significant changes in vital signs
Timepoint [16] 0 0
3 weeks on treatment
Secondary outcome [17] 0 0
AML Part 3d Incidence of clinically significant changes in ECGs
Timepoint [17] 0 0
3 weeks on treatment
Secondary outcome [18] 0 0
AML Part 3d Incidence of clinically significant changes in clinical laboratory tests
Timepoint [18] 0 0
3 weeks on treatment
Secondary outcome [19] 0 0
AML Part 4 Overall response (OR) according to the 2017 ELN criteria in AML subjects
Timepoint [19] 0 0
6 months on treatment
Secondary outcome [20] 0 0
AML Part 4 Event free survival (EFS)
Timepoint [20] 0 0
6 months on treatment
Secondary outcome [21] 0 0
AML Part 4 Time to response
Timepoint [21] 0 0
6 months on treatment
Secondary outcome [22] 0 0
AML Part 4 Duration of response (DOR)
Timepoint [22] 0 0
6 months on treatment
Secondary outcome [23] 0 0
AML Part 5 OR according to the 2017 ELN criteria in AML subjects
Timepoint [23] 0 0
6 months on treatment
Secondary outcome [24] 0 0
AML Part 5 EFS
Timepoint [24] 0 0
6 months on treatment
Secondary outcome [25] 0 0
AML Part 5 Time to response
Timepoint [25] 0 0
6 months on treatment
Secondary outcome [26] 0 0
AML Part 5 DOR
Timepoint [26] 0 0
6 months on treatment

Eligibility
Key inclusion criteria
INCLUSION CRITERIA:

* For participants in Japan only: if a participant is younger than 20 years at the time of signing the informed consent form, informed consent must be obtained from both the participant and his/her legal representative
* (Multiple myeloma [MM] participants) Pathologically documented, multiple myeloma relapsed or refractory disease after at least 2 lines of therapy
* (MM participants only) Measurable disease per the International Myeloma Working Group response criteria
* (Acute myeloid leukemia [AML] participants) AML as defined by the World Health Organization Classification persisting or recurring following one or more treatment courses, and for participants in Japan, determined by the investigator to be not eligible for approved anticancer drug therapy in Japan; EXCEPT acute promyelocytic leukemia.
* (AML participants only) More than 5% blasts in bone marrow and Circulating white blood cells < 25,000/ul.
* Must be willing and able to undergo a core bone marrow biopsy (MM participants only) and bone marrow aspirate (MM and AML participants) at screening.
* Eastern Cooperative Oncology Group (ECOG) performance status of = 2,
* (MM partiicpants only) Satisfactory hematological function without transfusion or growth factor support
* Life expectancy of > 3 months, in the opinion of the investigator
* Adequate hepatic function
* Adequate cardiac function
* Adequate renal function
* Female participants of childbearing potential must have a negative serum or urine pregnancy test
* Other inclusion criteria may apply

EXCLUSION CRITERIA:

* Previously received an allogeneic stem cell transplant within 6 months OR having received immunosuppressive therapy within the last three months OR having signs or symptoms of acute or chronic graft-versus-host disease
* Autologous stem cell transplant less than 90 days prior to study day 1
* (MM participants only) MM with Immunoglobulin M subtype
* (MM participants only) Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes syndrome
* (MM participants only) Existing plasma cell leukemia
* (MM participants only) Waldenstrom's macroglobulinemia
* (MM participants only) Amyloidosis
* Infection requiring intravenous anti-infective treatments within 1 week of study enrollment (day 1)
* Myocardial infarction within 6 months of enrollment, symptomatic congestive heart failure (New York Heart Association > class II)
* History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past 6 months prior to enrollment
* Currently receiving treatment in another investigational device or drug study. Other investigational procedures while participating in this study will be allowed if approved by Amgen medical monitor
* Participants with elevated cardiac troponin above the manufacturer's 99th percentile upper reference limit for ADVIA Centaur XP assay at screening performed by the central laboratory
* Participants with evidence of recent cardiac injury at screening based on creatine kinase-muscle/brain, N-terminal prohormone of brain natriuretic peptide, and electrocardiogram
* Other exclusion criteria may apply
* (AML Part 3d only) History of QT prolongation, torsades de pointes, ventricular tachycardia and cardiac arrest
* History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection unless agreed upon with medical monitor.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Germany
State/province [12] 0 0
Aachen
Country [13] 0 0
Germany
State/province [13] 0 0
Bonn
Country [14] 0 0
Germany
State/province [14] 0 0
Ulm
Country [15] 0 0
Germany
State/province [15] 0 0
Wuerzburg
Country [16] 0 0
Japan
State/province [16] 0 0
Aichi
Country [17] 0 0
Japan
State/province [17] 0 0
Chiba
Country [18] 0 0
Japan
State/province [18] 0 0
Fukuoka
Country [19] 0 0
Japan
State/province [19] 0 0
Okayama
Country [20] 0 0
Japan
State/province [20] 0 0
Tokyo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
At least one dose level of AMG 176 will achieve acceptable safety and tolerability in participants with relapsed or refractory multiple myeloma and participants with relapsed or refractory acute myeloid leukemia
Trial website
https://clinicaltrials.gov/study/NCT02675452
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02675452