Acute Myeloid LeukemiaPhase 1NCT00279773
Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia
A Phase 1 study testing TKI258 in people with Acute Myeloid Leukemia, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The primary objective is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of TKI258 when administered to subjects with acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- TKI258
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Oct 2007
- 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
- Confirmed diagnosis of Acute Myeloid Leukemia
- Eighteen years of age or older
- Life expectancy of at least 2 months
Who cannot join
- Intracranial disease or epidural disease
- Clinically significant cardiac disease
- Diabetes mellitus uncontrolled with medication
- Pregnant or breast feeding women
- Dementia or altered mental status
- Known pre-existing clinically significant or uncontrolled disorder of the hypothalamic-pituitary axis, adrenal or thyroid glands
- Previous pericarditis
- Malabsorption syndrome or uncontrolled gastrointestinal symptoms such as nausea,diarrhea,vomiting
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas, M.D. Anderson Cancer Center
Houston, Texas, 77020
About this study
Official title: A Phase I Dose Escalating Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia
The primary objective is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of TKI258 when administered to subjects with acute myeloid leukemia (AML).
- Conditions
- Acute Myeloid Leukemia
- Being tested
- TKI258
- Keywords
- Acute, Myeloid, Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKI258Drug
| Study group | Role | What they receive |
|---|---|---|
| TKI258 - dose escalation | Experimental | Dose-Escalation Receives: Drug: TKI258 |
| TKI258 - dose expansion | Experimental | Dose-Expansion Receives: Drug: TKI258 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: 28 days - dose-escalation; 4 months - dose-expansion
Dose limiting toxicity
Measured: 28 days - dose-escalation; 4 months - dose-expansion
Safety profile
Measured: 28 days - dose-escalation; 4 months - dose-expansion
Secondary outcomes (1)
Evaluation of plasma pharmacokinetics and pharmacodynamics
Measured: 28 days - dose-escalation; 4 months - dose-expansion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2006 (estimated)
- Study startSep 2004
- Primary completionOct 2007
Why it stopped: Study was stopped due to time dependent drug accumulation
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 Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279773
- Sponsor's protocol ID
- CTKI258A2102
- Status last verified
- Jun 2010
- First submitted
- 18 Jan 2006
- Last updated
- 30 Jun 2010
- Results posted
- No
Publications
Wang X, Kay A, Anak O, Angevin E, Escudier B, Zhou W, Feng Y, Dugan M, Schran H. Population pharmacokinetic/pharmacodynamic modeling to assist dosing schedule selection for dovitinib. J Clin Pharmacol. 2013 Jan;53(1):14-20. doi: 10.1177/0091270011433330. Epub 2013 Jan 24.
PubMed 23400739
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalating Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00279773
- Acronym / sponsor ID
- CTKI258A2102
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute, Myeloid, Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to time dependent drug accumulation
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Oct 2007 (actual)
- First posted
- 20 Jan 2006 (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.
The primary objective is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of TKI258 when administered to subjects with acute myeloid leukemia (AML).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TKI258 - dose escalation | Experimental | Drug: TKI258Dose-Escalation |
| TKI258 - dose expansion | Experimental | Drug: TKI258Dose-Expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of Acute Myeloid Leukemia
- Eighteen years of age or older
- Life expectancy of at least 2 months
Key exclusion criteria (8 listed)
- Intracranial disease or epidural disease
- Clinically significant cardiac disease
- Diabetes mellitus uncontrolled with medication
- Pregnant or breast feeding women
- Dementia or altered mental status
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 |
|---|---|---|
| TKI258 | Drug | TKI258 - dose escalation, TKI258 - dose expansion |
Primary outcome
Maximum tolerated dose
Time frame: 28 days - dose-escalation; 4 months - dose-expansion
Dose limiting toxicity
Time frame: 28 days - dose-escalation; 4 months - dose-expansion
Safety profile
Time frame: 28 days - dose-escalation; 4 months - dose-expansion
1 secondary outcome
Evaluation of plasma pharmacokinetics and pharmacodynamics
Time frame: 28 days - dose-escalation; 4 months - dose-expansion
Results and safety
The study was stopped early (reason given: Study was stopped due to time dependent drug accumulation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2010.
- Derived from this study: PubMed 23400739Wang X, Kay A, Anak O, Angevin E, Escudier B, Zhou W, Feng Y, Dugan M, Schran H. Population pharmacokinetic/pharmacodynamic modeling to assist dosing schedule selection for dovitinib. J Clin Pharmacol. 2013 Jan;53(1):14-20. doi: 10.1177/0091270011433330. Epub 2013 Jan 24.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TKI258 in people with Acute Myeloid Leukemia, run by Novartis Pharmaceuticals at 1 site 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 8 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: stopped early, as of the sponsor's last update on 30 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Study was stopped due to time dependent drug accumulation). Results are not available in the source record.
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?
Maximum tolerated dose (time frame: 28 days - dose-escalation; 4 months - dose-expansion). 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 NCT00279773, 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 30 Jun 2010.