A Phase 1 interventional study of Arm 1- Dose Escalation and Arm 1- Dose Expansion in Advanced Malignancy, Advanced Solid Tumors and Cancer, sponsored by Amgen. Completed at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-06.
Sponsored by Amgen · Phase 1, Interventional, and Treatment
This first-in-human study of AMG 900 will be conducted in two parts: dose escalation and dose expansion. The dose escalation part of the study is aimed at evaluating the safety, tolerability and PK of oral AMG 900 in subjects with advanced solid tumors. Up to 50 subjects may be enrolled in dose escalation. The dose expansion part of the study will consist of 42 subjects in three taxane-resistant tumor types. The dose of AMG 900 will be dependent upon data from the dose escalation part of the study
that G-CSF must be started at day 5, 1 day after the last day of AMG 900 and be continued until neutrophiles are > 1000 or until day 12, meaning 2 days before the reinduction.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 95 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Amgen is the lead sponsor of 1,044 studies on the registry; 51 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 164 (67%) have results posted.
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The dose expansion part of the study will begin after completion of the dose escalation phase and will consist of 3 cohorts of 14 subjects each. One taxane-resistant tumor type will be evaluated in each cohort.
Drug: Arm 1- Dose Expansion
The dose escalation part of the study is aimed at determining the maximum tolerated dose (MTD) of AMG 900 and if necessary, the MTD with prophylactic GCSF support (MTD-G).
Drug: Arm 1- Dose Escalation
AMG 900 is a small molecule inhibitor of aurora kinases A, B and C. AMG 900 will be administered daily for 4 days every 2 weeks (i.e., 4 consecutive days of dosing followed by 10 consecutive days off treatment).
AMG 900 is a small molecule inhibitor of aurora kinases A, B and C. AMG 900 will be administered daily for 4 days every 2 weeks (i.e., 4 consecutive days of dosing followed by 10 consecutive days off treatment).
Safety: subject incidence of adverse events, first-cycle DLTs and clinically significant changes in vital signs, weight, ECGs and clinical laboratory tests
Time frame: 1 year
PK profile: AMG 900 PK parameters including, but not limited to, maximum observed concentration (Cmax), minimum observed concentration, area under the plasma concentration-time curve and, if feasible, half-life
Time frame: 1 year
Change in levels of p-Histone H3 from baseline (part 1 - dose escalation only)
Time frame: 1 year
Response rate in each taxane-resistant tumor type assessed per RECIST guidelines (part 2 - dose expansion only)
Time frame: 1 year
Change in tumor volume from baseline measured by volumetric CT or MRI
Time frame: 1 year
Tumor response measured by CT or MRI and assessed per RECIST guidelines
Time frame: 1 year
Change from baseline in maximum standardized uptake value (SUVmax) using 18FLT-PET/CT (part 2 - dose expansion only)
Time frame: 1 year
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 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 (or other new use) 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.
Access criteria: 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 link below.
Data sharing details ↗ · www.amgen.com
Ran from Aug 2009 to primary completion in Dec 2014, 64 months.
Of 1,085 industry-sponsored phase 1 interventional studies under Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 58. This study's 64 months is above that.
Counting every sponsor, half of 1,494 studies reached it within 40 months; a quarter within 25 and three quarters within 63.
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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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