Myeloproliferative DisordersPhase 1NCT00522574
A Safety Study of XL019 in Adults With Myelofibrosis
A Phase 1 study testing XL019 in people with Myeloproliferative Disorders and Myelofibrosis, run by Exelixis at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of XL019 in adults with myelofibrosis. XL019 is a selective inhibitor of the cytoplasmic tyrosine kinase JAK2. JAK2 is activated by cytokine and growth factor receptors and phosphorylates members of the STAT family of inducible transcription factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Disorders, Myelofibrosis, Polycythemia Vera
- What is being tested?
- XL019
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2007to not given
- 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
- The subject has primary myelofibrosis (PMF), post-polycythemia vera MF, or post-essential thrombocythemia MF and requires therapy, including subjects who have received prior MF-directed therapy and relapsed or subjects with refractory disease; or if newly diagnosed, then with intermediate or high risk according to the Lille scoring system.
- The subject is unwilling to undergo or is not a candidate for peripheral stem cell/bone marrow transplant.
- The subject is ≥18 years old.
- The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- The subject has adequate organ function.
- The subject has the capability of understanding the informed consent document and has signed the informed consent document.
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- Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.
- Female subjects of childbearing potential must have a negative pregnancy test at screening.
- The subject has had no diagnosis of malignancy or evidence of other malignancy for 2 years prior to screening for this study (except non-melanoma skin cancer or in situ carcinoma of the cervix).
Who cannot join
- The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within 3 months, or cardiac arrhythmias.
- The subject is pregnant or breastfeeding.
- The subject is known to be positive for the human immunodeficiency virus (HIV).
- The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
MD Anderson Cancer Center
Houston, Texas, 77030
Mt. Sinai School of Medicine
New York, New York, 10029
UCSF - Division of Hematology/Oncology
San Francisco, California, 94143
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL019 Administered to Subjects With Myelofibrosis
The purpose of this study is to evaluate the safety and tolerability of XL019 in adults with myelofibrosis. XL019 is a selective inhibitor of the cytoplasmic tyrosine kinase JAK2. JAK2 is activated by cytokine and growth factor receptors and phosphorylates members of the STAT family of inducible transcription factors. Activation of the JAK/STAT pathway promotes cell growth and survival, and is a common feature of human tumors. JAK2 is activated by mutation in the majority of patients with myelofibrosis, polycythemia vera and essential thrombocytosis and appears to drive the inappropriate growth of blood cells in these conditions.
- Conditions
- Myeloproliferative Disorders, Myelofibrosis, Polycythemia Vera, Thrombocythemia, Essential
- Being tested
- XL019
- Keywords
- Myeloproliferative Disorders
- Medical subject headings
- Myeloproliferative Disorders, Primary Myelofibrosis, Polycythemia Vera, Thrombocythemia, Essential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XL019Drug
gelatin capsules supplied in 5-mg, 25-mg, and 100-mg strengths
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety, tolerability, maximum tolerated dose, and dose-limiting toxicities of XL019 as a single agent when orally administered in subjects with PMF, post-PV MF, or post-ET MF.
Measured: Assessed at periodic visits
Secondary outcomes (2)
Determine plasma pharmacokinetics, evaluate pharmacodynamic correlates, and estimate renal elimination of XL019
Measured: Assessed at periodic visits
Evaluate preliminary efficacy of XL019 as a single agent when administered orally
Measured: Assessed at periodic visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startAug 2007
Why it stopped: Due to emerging safety data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative DisordersStudies of the same condition, open and under way.
- More trials run by ExelixisThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exelixis
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522574
- Sponsor's protocol ID
- XL019-001
- Status last verified
- Apr 2011
- First submitted
- 27 Aug 2007
- Last updated
- 5 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL019 Administered to Subjects With Myelofibrosis
- ClinicalTrials.gov ID
- NCT00522574
- Acronym / sponsor ID
- XL019-001
- Conditions
- Myeloproliferative Disorders, Myelofibrosis, Polycythemia Vera, Thrombocythemia, Essential
- Keywords
- Myeloproliferative Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to emerging safety data
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ExelixisIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- First posted
- 29 Aug 2007 (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 purpose of this study is to evaluate the safety and tolerability of XL019 in adults with myelofibrosis. XL019 is a selective inhibitor of the cytoplasmic tyrosine kinase JAK2. JAK2 is activated by cytokine and growth factor receptors and phosphorylates members of the STAT family of inducible transcription factors. Activation of the JAK/STAT pathway promotes cell growth and survival, and is a common feature of human tumors. JAK2 is activated by mutation in the majority of patients with myelofibrosis, polycythemia vera and essential thrombocytosis and appears to drive the inappropriate growth of blood cells in these conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subject has primary myelofibrosis (PMF), post-polycythemia vera MF, or post-essential thrombocythemia MF and requires therapy, including subjects who have received prior MF-directed therapy and relapsed or subjects with refractory disease; or if newly diagnosed, then with intermediate or high risk according to the Lille scoring system.
- The subject is unwilling to undergo or is not a candidate for peripheral stem cell/bone marrow transplant.
- The subject is ≥18 years old.
- The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- The subject has adequate organ function.
Key exclusion criteria (4 listed)
- The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within 3 months, or cardiac arrhythmias.
- The subject is pregnant or breastfeeding.
- The subject is known to be positive for the human immunodeficiency virus (HIV).
- The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
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 |
|---|---|---|
| XL019gelatin capsules supplied in 5-mg, 25-mg, and 100-mg strengths | Drug | – |
Primary outcome
To evaluate the safety, tolerability, maximum tolerated dose, and dose-limiting toxicities of XL019 as a single agent when orally administered in subjects with PMF, post-PV MF, or post-ET MF.
Time frame: Assessed at periodic visits
2 secondary outcomes
Determine plasma pharmacokinetics, evaluate pharmacodynamic correlates, and estimate renal elimination of XL019
Time frame: Assessed at periodic visits
Evaluate preliminary efficacy of XL019 as a single agent when administered orally
Time frame: Assessed at periodic visits
Results and safety
The study was stopped early (reason given: Due to emerging safety data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 XL019 in people with Myeloproliferative Disorders and Myelofibrosis, run by Exelixis 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 9 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: stopped early, as of the sponsor's last update on 5 Apr 2011. 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 was stopped early (reason given: Due to emerging safety data). 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?
To evaluate the safety, tolerability, maximum tolerated dose, and dose-limiting toxicities of XL019 as a single agent when orally administered in subjects with PMF, post-PV MF, or post-ET MF. (time frame: Assessed at periodic visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2011.