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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00858377




Registration number
NCT00858377
Ethics application status
Date submitted
26/02/2009
Date registered
9/03/2009

Titles & IDs
Public title
A Phase 1 First-in-Human Study Evaluating AMG 900 in Advanced Solid Tumors
Scientific title
A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered AMG 900 in Adult Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
20080016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Malignancy 0 0
Advanced Solid Tumors 0 0
Cancer 0 0
Solid Tumors 0 0
Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Arm 1- Dose Escalation
Treatment: Drugs - Arm 1- Dose Expansion

Experimental: Arm 1- Dose Expansion - 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.

Experimental: Arm 1- Dose Escalation - 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).


Treatment: Drugs: 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).

Treatment: Drugs: Arm 1- Dose Expansion
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).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety: subject incidence of adverse events, first-cycle DLTs and clinically significant changes in vital signs, weight, ECGs and clinical laboratory tests
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
1 year
Primary outcome [3] 0 0
Change in levels of p-Histone H3 from baseline (part 1 - dose escalation only)
Timepoint [3] 0 0
1 year
Primary outcome [4] 0 0
Response rate in each taxane-resistant tumor type assessed per RECIST guidelines (part 2 - dose expansion only)
Timepoint [4] 0 0
1 year
Secondary outcome [1] 0 0
Change in tumor volume from baseline measured by volumetric CT or MRI
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Tumor response measured by CT or MRI and assessed per RECIST guidelines
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Change from baseline in maximum standardized uptake value (SUVmax) using 18FLT-PET/CT (part 2 - dose expansion only)
Timepoint [3] 0 0
1 year

Eligibility
Key inclusion criteria
* Men or women = 18 years old
* Part 1 Dose Escalation only: advanced solid tumor refractory to standard treatment for which no standard therapy is available or the subject refuses standard therapy
* Part 1 Dose Escalation only: Measurable or evaluable disease per RECIST guidelines
* Part 2 Dose Expansion only: Taxane-resistant tumor (defined as refractory to or progression within 6 months of discontinuing paclitaxel or docetaxel) of prespecified histology
* Part 2 Dose Expansion only: Measurable disease per RECIST guidelines
* Eastern Cooperative Oncology Group (ECOG) Performance Status of = 2
* Life expectancy of > 3 months, in the opinion of the investigator
* Willing to provide existing and/or future paraffin-embedded tumor samples
* Part 1 Dose Escalation: must have tumor tissue that is accessible for biopsy by fine needle aspiration (FNA) and must consent to undergo biopsies of their tumor (subjects in non-accelerated phase only)
* Ability to take oral medications
* Competent to sign and date an Institutional Review Board approved informed consent form
* Absolute neutrophil count (ANC) = 1.5 x 109/L
* Platelet count = 100 x 109/L
* Hemoglobin > 9 g/dL
* Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)
* Serum creatinine < 2.0 mg/dL
* Calculated creatinine clearance = 50 ml/min
* AST < 2.5 x ULN (if liver or bone metastases are present, = 5 x ULN)
* ALT < 2.5 x ULN (if liver or bone metastases are present, = 5 x ULN)
* Alkaline phosphatase < 2.0 x ULN (if liver or bone metastases are present, = 5 x ULN)
* Total bilirubin < 1.5 x ULN
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active parenchymal brain metastases. Subjects who have had brain metastases resected or have received radiation therapy ending at least 4 weeks prior to study day 1 are eligible if they meet all of the following criteria: a) residual neurological symptoms grade < 1; b) no dexamethasone requirement; and c) follow-up MRI shows no new lesions appearing
* Prior bone marrow transplant (autologous or allogeneic)
* History or presence of hematological malignancies
* History of bleeding diathesis
* Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication
* Active peptic ulcer disease
* Gastrointestinal (GI) tract disease causing the inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (eg, Crohn's disease, ulcerative colitis)
* Active infection requiring intravenous (IV) antibiotics within 2 weeks of study enrollment (day 1)
* Known positive test for HIV
* Active or chronic hepatitis B or hepatitis C infection, determined by serologic tests
* Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade 0 or 1, or to levels dictated in the eligibility criteria with the exception of alopecia
* Anti-tumor therapy within 28 days of study day 1; concurrent use of hormone deprivation therapy for hormone-refractory prostate cancer or breast cancer is permitted
* Treatment with immune modulators including, but not limited to, corticosteroids, cyclosporine and tacrolimus within two weeks prior to enrollment
* Therapeutic or palliative radiation therapy within two weeks of study day 1
* Systemic anticoagulation therapy, including warfarin, within 28 days of day 1
* Prior treatment with aurora inhibitors
* Prior participation in an investigational study (drug or device) within 28 days of study day 1
* Major surgery within 28 days of study day 1
* Any co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsor

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Single group
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
10/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/04/2019
Sample size
Target
Accrual to date
Final
95
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Research Site - Kurralta Park
Recruitment hospital [2] 0 0
Research Site - Bentleigh East
Recruitment hospital [3] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [2] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Nevada
Country [5] 0 0
United States of America
State/province [5] 0 0
New Mexico

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00858377