Advanced MalignancyPhase 1NCT02016729
A Phase 1b Study Evaluating AMG 232 Alone and in Combination With Trametinib in Acute Myeloid Leukemia
A Phase 1 study testing AMG 232 and Trametinib in people with Advanced Malignancy and Cancer, run by Kartos Therapeutics, Inc. at 5 sites in United States.
Trial summary
Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancy, Cancer, Oncology
- What is being tested?
- AMG 232 and Trametinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Apr 2014to 31 Jul 2017
- 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 is relapsed or refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy
- Ability to take oral medications and willing to record daily adherance to investigational product
- Adequate hematological, renal, hepatic, and coagulation laboratory assessments
Who cannot join
- Active infection requiring intravenous (IV) antibiotics
- Prior participation in an investigational study (procedure or device) within 21 days of study day 1
- Major surgery within 28 days of study day 1
- Anti-tumor therapy within 14 days of study day 1
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Research Site
Birmingham, Alabama, 35294
Research Site
Buffalo, New York, 14263
Research Site
Charlotte, North Carolina, 28204
Research Site
Salt Lake City, Utah, 84112
Research Site
Seattle, Washington, 98101
About this study
Official title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 232 Alone and in Combination With Trametinib in Adult Subjects With Relapsed/Refractory Acute Myeloid Leukemia
Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute myeloid leukemia.
- Conditions
- Advanced Malignancy, Cancer, Oncology, Oncology Patients, Acute Myeloid Leukemia
- Being tested
- AMG 232, Trametinib
- Keywords
- AML
- Medical subject headings
- Neoplasms, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 232Drug
Given an an oral tablet in escalating doses.
TrametinibDrug
Trametinib is an oral tablet given in a fixed dose.
| Study group | Role | What they receive |
|---|---|---|
| AMG 232 | Experimental | AMG 232 is an anti-cancer agent Receives: Drug: AMG 232; Drug: Trametinib |
| AMG 232 & Trametinib | Experimental | AMG 232 and Trametinib are anti cancer agents Receives: Drug: Trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of AMG 232
To evaluate the safety and tolerability of AMG 232 by reviewing clinically significant or ≥ Grade 3 changes in safety laboratory tests, physical examinations, ECGs, or vitals signs in all subjects enrolled.
Measured: 36 months
Characterize the pharmacokinetics of AMG 232 alone and in combination with trametinib when administered orally.
PK parameters will include, but are not limited to, area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax).
Measured: 36 months
Determine the maximum tolerated dose of AMG 232 alone and in combination with trametinib, if possible.
The MTD is defined at the highest dose level with an observed incidence of dose limiting toxicity in < 33% of subjects enrolled in a cohort.
Measured: 36 months
Secondary outcomes (1)
Treatment Response
Complete response (CR), complete response with incomplete recovery (CRi), and duration response.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study start1 Apr 2014
- Primary completion19 Apr 2017
- Study completion31 Jul 2017
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 Advanced MalignancyStudies of the same condition, open and under way.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kartos Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016729
- Sponsor's protocol ID
- 20120234
- Status last verified
- Feb 2019
- First submitted
- 21 Nov 2013
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Erba HP, Becker PS, Shami PJ, Grunwald MR, Flesher DL, Zhu M, Rasmussen E, Henary HA, Anderson AA, Wang ES. Phase 1b study of the MDM2 inhibitor AMG 232 with or without trametinib in relapsed/refractory acute myeloid leukemia. Blood Adv. 2019 Jul 9;3(13):1939-1949. doi: 10.1182/bloodadvances.2019030916.
PubMed 31253596
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 232 Alone and in Combination With Trametinib in Adult Subjects With Relapsed/Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02016729
- Acronym / sponsor ID
- 20120234
- Conditions
- Advanced Malignancy, Cancer, Oncology, Oncology Patients, Acute Myeloid Leukemia
- Keywords
- AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Kartos Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 19 Apr 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 20 Dec 2013 (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.
Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute myeloid leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 232 | Experimental | Drug: AMG 232, Drug: TrametinibAMG 232 is an anti-cancer agent |
| AMG 232 & Trametinib | Experimental | Drug: TrametinibAMG 232 and Trametinib are anti cancer agents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women > 18 years old
- Pathologically-documented, definitively-diagnosed AML that is relapsed or refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy
- Ability to take oral medications and willing to record daily adherance to investigational product
- Adequate hematological, renal, hepatic, and coagulation laboratory assessments
Key exclusion criteria (4 listed)
- Active infection requiring intravenous (IV) antibiotics
- Prior participation in an investigational study (procedure or device) within 21 days of study day 1
- Major surgery within 28 days of study day 1
- Anti-tumor therapy within 14 days of study day 1
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 |
|---|---|---|
| AMG 232Given an an oral tablet in escalating doses. | Drug | AMG 232 |
| TrametinibTrametinib is an oral tablet given in a fixed dose. | Drug | AMG 232, AMG 232 & Trametinib |
Primary outcome
To evaluate the safety and tolerability of AMG 232
Time frame: 36 months
To evaluate the safety and tolerability of AMG 232 by reviewing clinically significant or ≥ Grade 3 changes in safety laboratory tests, physical examinations, ECGs, or vitals signs in all subjects enrolled.
Characterize the pharmacokinetics of AMG 232 alone and in combination with trametinib when administered orally.
Time frame: 36 months
PK parameters will include, but are not limited to, area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax).
Determine the maximum tolerated dose of AMG 232 alone and in combination with trametinib, if possible.
Time frame: 36 months
The MTD is defined at the highest dose level with an observed incidence of dose limiting toxicity in < 33% of subjects enrolled in a cohort.
1 secondary outcome
Treatment Response
Time frame: 36 months
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 27 Feb 2019.
- Derived from this study: PubMed 31253596Erba HP, Becker PS, Shami PJ, Grunwald MR, Flesher DL, Zhu M, Rasmussen E, Henary HA, Anderson AA, Wang ES. Phase 1b study of the MDM2 inhibitor AMG 232 with or without trametinib in relapsed/refractory acute myeloid leukemia. Blood Adv. 2019 Jul 9;3(13):1939-1949. doi: 10.1182/bloodadvances.2019030916.
- 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
5 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 AMG 232 and Trametinib in people with Advanced Malignancy and Cancer, run by Kartos Therapeutics, Inc. at 5 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 4 inclusion and 4 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 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
To evaluate the safety and tolerability of AMG 232 (time frame: 36 months). The study lists 3 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 NCT02016729, 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 27 Feb 2019.