CancerPhase 1NCT01380756
Study Evaluating Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia
A Phase 1 study testing Arm 1- Dose Escalation and Arm 2- Dose Expansion in people with Cancer and Hematologic Malignancies, run by Amgen at 3 sites in United States.
Trial summary
This 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 (pharmacokinetics) of oral AMG 900 in subjects with acute myeloid leukemia. Up to 93 subjects may be enrolled in dose escalation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Hematologic Malignancies, Leukemia
- What is being tested?
- Arm 1- Dose Escalation and Arm 2- Dose Expansion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Oct 2011to 4 Sep 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women ≥ 18 years old
- Pathologically documented, definitively diagnosed AML that has failed standard treatments or for which no standard therapy is available or the subject refuses standard therapy
- Must consent to undergo bone marrow biopsies per schedule of assessments
Who cannot join
- White blood cell greater than 20,000 uL
- History of or active central nervous system leukemia
- Prior allogeneic bone marrow transplant
- Subject will not be available for protocol-required study visits or procedures
- Other Inclusion/ Exclusion Criteria may apply to qualify for enrollment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Cleveland, Ohio, 44195
Research Site
Houston, Texas, 77030
Research Site
Stony Brook, New York, 11794
About this study
Official title: A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia
This 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 (pharmacokinetics) of oral AMG 900 in subjects with acute myeloid leukemia. Up to 93 subjects may be enrolled in dose escalation. The dose expansion part of the study will consist of 20 subjects with acute myeloid leukemia. The dose of AMG 900 will be dependent upon data from the dose escalation part of the study.
- Conditions
- Cancer, Hematologic Malignancies, Leukemia, Myeloid Leukemia
- Being tested
- Arm 1- Dose Escalation, Arm 2- Dose Expansion
- Keywords
- Amgen, Phase 1, Clinical Trial, Aurora kinase inhibitor, Open label, Oncology, Hematology
- Medical subject headings
- Neoplasms, Hematologic Neoplasms, Leukemia, Leukemia, Myeloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1- Dose EscalationDrug
AMG 900 is a small molecule aurora kinase inhibitor. AMG 900 will be administered daily for 4 days every 2 weeks or daily 7 days every 2 weeks (ie.g., 4 consecutive days of dosing followed by 10 consecutive days off treatment).
Arm 2- Dose ExpansionDrug
AMG 900 is a small molecule aurora kinases inhibitor. The dose expansion phase would be conducted to gain further clinical experience with AMG 900 in AML at the optimal dose schedule.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1- Dose Escalation | Experimental | The dose escalation will be conducted in 2 parts. Group 1 will consist of 8 cohorts and Group 2 will consist of 5 cohorts. The dose escalation is aimed at determining the maximum tolerated dose (MTD) of AMG 900. Receives: Drug: Arm 1- Dose Escalation |
| Arm 2- Dose Expansion | Experimental | The dose expansion part of the study will begin after completion of the dose escalation phase and will consist of 20 subjects with acute myelogenous leukemia. Receives: Drug: Arm 2- Dose Expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject incidence of adverse events
Measured: 1 year
Subject incidence of dose limiting toxicities (DLTs)
Measured: 1 year
Maximum observed concentration of AMG 900
Measured: 1 year
Time to maximum observed concentration of AMG 900
Measured: 1 year
Area under the plasma concentration-time curve (AUC) of AMG 900
Measured: 1 year
Half life of AMG 900
Measured: 1 year
Secondary outcomes (2)
Objective response as per Cheson Response Criteria
Measured: 1 year
Change in the number of p-Histone H3 positive cells from baseline
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study start4 Oct 2011
- Primary completion4 Sep 2014
- Study completion4 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380756
- Sponsor's protocol ID
- 20101351
- Status last verified
- Nov 2017
- First submitted
- 9 Jun 2011
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kantarjian HM, Schuster MW, Jain N, Advani A, Jabbour E, Gamelin E, Rasmussen E, Juan G, Anderson A, Chow VF, Friberg G, Vogl FD, Sekeres MA. A phase 1 study of AMG 900, an orally administered pan-aurora kinase inhibitor, in adult patients with acute myeloid leukemia. Am J Hematol. 2017 Jul;92(7):660-667. doi: 10.1002/ajh.24736. Epub 2017 Jun 5.
PubMed 28370201
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT01380756
- Acronym / sponsor ID
- 20101351
- Conditions
- Cancer, Hematologic Malignancies, Leukemia, Myeloid Leukemia
- Keywords
- Amgen, Phase 1, Clinical Trial, Aurora kinase inhibitor, Open label, Oncology, Hematology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2011 (actual)
- Primary completion
- 4 Sep 2014 (actual)
- Study completion
- 4 Sep 2014 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 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 (pharmacokinetics) of oral AMG 900 in subjects with acute myeloid leukemia. Up to 93 subjects may be enrolled in dose escalation. The dose expansion part of the study will consist of 20 subjects with acute myeloid leukemia. The dose of AMG 900 will be dependent upon data from the dose escalation part of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1- Dose Escalation | Experimental | Drug: Arm 1- Dose EscalationThe dose escalation will be conducted in 2 parts. Group 1 will consist of 8 cohorts and Group 2 will consist of 5 cohorts. The dose escalation is aimed at determining the maximum tolerated dose (MTD) of AMG 900. |
| Arm 2- Dose Expansion | Experimental | Drug: Arm 2- Dose ExpansionThe dose expansion part of the study will begin after completion of the dose escalation phase and will consist of 20 subjects with acute myelogenous leukemia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women ≥ 18 years old
- Pathologically documented, definitively diagnosed AML that has failed standard treatments or for which no standard therapy is available or the subject refuses standard therapy
- Must consent to undergo bone marrow biopsies per schedule of assessments
Key exclusion criteria (5 listed)
- White blood cell greater than 20,000 uL
- History of or active central nervous system leukemia
- Prior allogeneic bone marrow transplant
- Subject will not be available for protocol-required study visits or procedures
- Other Inclusion/ Exclusion Criteria may apply to qualify for enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1- Dose EscalationAMG 900 is a small molecule aurora kinase inhibitor. AMG 900 will be administered daily for 4 days every 2 weeks or daily 7 days every 2 weeks (ie.g., 4 consecutive days of dosing followed by 10 consecutive days off treatment). | Drug | Arm 1- Dose Escalation |
| Arm 2- Dose ExpansionAMG 900 is a small molecule aurora kinases inhibitor. The dose expansion phase would be conducted to gain further clinical experience with AMG 900 in AML at the optimal dose schedule. | Drug | Arm 2- Dose Expansion |
Primary outcome
Subject incidence of adverse events
Time frame: 1 year
Subject incidence of dose limiting toxicities (DLTs)
Time frame: 1 year
Maximum observed concentration of AMG 900
Time frame: 1 year
Time to maximum observed concentration of AMG 900
Time frame: 1 year
Area under the plasma concentration-time curve (AUC) of AMG 900
Time frame: 1 year
Half life of AMG 900
Time frame: 1 year
2 secondary outcomes
Objective response as per Cheson Response Criteria
Time frame: 1 year
Change in the number of p-Histone H3 positive cells from baseline
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Background: PubMed 28370201Kantarjian HM, Schuster MW, Jain N, Advani A, Jabbour E, Gamelin E, Rasmussen E, Juan G, Anderson A, Chow VF, Friberg G, Vogl FD, Sekeres MA. A phase 1 study of AMG 900, an orally administered pan-aurora kinase inhibitor, in adult patients with acute myeloid leukemia. Am J Hematol. 2017 Jul;92(7):660-667. doi: 10.1002/ajh.24736. Epub 2017 Jun 5.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Arm 1- Dose Escalation and Arm 2- Dose Expansion in people with Cancer and Hematologic Malignancies, run by Amgen at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject incidence of adverse events (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01380756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.