Accelerated Phase Chronic Myelogenous LeukemiaPhase 2NCT00387426
Sunitinib in Treating Patients With Idiopathic Myelofibrosis
A Phase 2 study testing sunitinib malate in people with Accelerated Phase Chronic Myelogenous Leukemia and Acute Undifferentiated Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II trial is studying how well sunitinib works in treating patients with idiopathic myelofibrosis. Sunitinib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the abnormal cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Accelerated Phase Chronic Myelogenous Leukemia, Acute Undifferentiated Leukemia, Adult Acute Lymphoblastic Leukemia in Remission
- What is being tested?
- sunitinib malate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Feb 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of MF (histologically confirmed) requiring therapy, including those previously treated and relapsed or refractory (no more than one prior standard acute leukemia-type chemotherapy regimen; no limit on prior MF - directed therapies) or if newly diagnosed, with intermediate or high risk according to Lille scoring system (adverse prognostic factors are: Hb < 10 g/dl, WBC < 4 or > 30 x 10^9/L; risk group: 0 = low, 1 = intermediate, 2 = high), or with symptomatic organomegaly.
- Serum bilirubin levels </= 2x upper limit of the normal (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or MF
- Serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels </= 2x ULN. Higher levels are acceptable if these can be attributed to MF.
- Serum creatinine levels </= 2x ULN.
- Eighteen years of age or older.
- ECOG performance status 0-1 (Karnofsky </= 70%).
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- Patients must have QTc < 500 msec
- Women of childbearing potential and men must agree to use adequate contraception (e.g. hormonal or barrier method of birth control; abstinence) for the duration of study participation. All women of childbearing potential must have a negative pregnancy test prior to receiving sunitinib. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document
- Both men and women and members of all races and ethnic groups are eligible for this trial.
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to beginning treatment or those who have not recovered from treatment-limiting adverse events (to grade 1 or better) due to agents administered more than 4 weeks earlier. At least 4 weeks must have elapsed since any major surgery prior to study enrollment. Continuous use of supportive care medications (i. e. growth factors, anagrelide, or hydroxyurea) is allowed.
- Patients may not be receiving any other investigational agents.
- Patients who have received prior treatment with any other specific antiangiogenic agent (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, PTK787, VEGF Trap, etc.) targeting VEGF/VEGFR system. Other agents that may have some antiangiogenic effects are allowed). (i.e. thalidomide)
- Patients with abnormal QTc prolongation (defined as a QTc interval equal to or greater than 500 msec) or patients who have a history of serious ventricular arrhythmia (VT or VF>/= 3 beats in a row or other significant (as judged by treating physician) ECG abnormalities.Patients with consistently poorly controlled (during the month prior to study screening) hypertension (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher) despite appropriate medical management of the hypertension.
- Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin. Exceptions include: patients using warfarin of up to 2 mg daily for prophylaxis of thrombosis, and patients using low molecular weight heparin provided the patient's INR is </= 1.5.
- Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain sunitinib tablets.
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- Patients with any of the following conditions:·Serious or non-healing wound, ulcer, or bone fracture, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment,·cerebrovascular accident (CVA) or transient ischemic attack, myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting, or pulmonary embolism within 12 months prior to study,·Class III or IV heart failure as defined by the NYHA functional classification system.
- Because sunitinib is metabolized primarily by the CYP3A4 liver enzyme, the eligibility of patients taking medications that are potent inducers or inhibitors of that enzyme will be determined following a review of their case by the Principal Investigator. Every effort should be made to switch patients taking such agents or substances to other medications.
- Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medications.
- Patients with uncontrolled intercurrent illness (as judged by treating physician) including, but not limited to, ongoing or active infections requiring IV antibiotics.
- Pregnant women are excluded from this study because sunitinib is an antiangiogenic agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sunitinib, breastfeeding should be discontinued if the mother is treated with sunitinib malate.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sunitinib. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Sunitinib Malate in Idiopathic Myelofibrosis
This phase II trial is studying how well sunitinib works in treating patients with idiopathic myelofibrosis. Sunitinib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the abnormal cells.
Read the detailed description
PRIMARY OBJECTIVE:
- Assess the response rate and the duration of response in patients with idiopathic myelofibrosis treated with sunitinib malate.
SECONDARY OBJECTIVE:
- Assess the safety of sunitinib malate in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral sunitinib malate once daily for 6 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Acute Undifferentiated Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Being tested
- sunitinib malate
- Medical subject headings
- Leukemia, Myeloid, Accelerated Phase, Leukemia, Biphenotypic, Acute, Congenital Abnormalities, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Blast Crisis, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Chronic-Phase, Leukemia, Mast-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinib malateDrug
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral sunitinib malate once daily for 6 weeks. Receives: Drug: sunitinib malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Objective Clinical Response to Sunitinib Therapy
Participant response assessed after two cycles of therapy according to categories: 1) complete response, 2) partial response, 3) clinical improvement, 4) stable disease 5) progressive disease, 6) early death from malignant disease, 7) early death from toxicity, 8) early death because of other cause, or 9) unknown (not assessable, insufficient data).
Measured: After two 6-week treatment courses (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Accelerated Phase Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Srdan Verstovsek, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387426
- Sponsor's protocol ID
- NCI-2009-00207
- Other IDs
- NCI-2009-00207, CDR0000504056, 2006-0208, 2006-0208, 7700, N01CM62202
- Status last verified
- Oct 2013
- First submitted
- 12 Oct 2006
- Last updated
- 28 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Sunitinib Malate in Idiopathic Myelofibrosis
- ClinicalTrials.gov ID
- NCT00387426
- Acronym / sponsor ID
- NCI-2009-00207
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Acute Undifferentiated Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Sep 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 13 Oct 2006 (estimated)
- Results
- Posted 14 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying how well sunitinib works in treating patients with idiopathic myelofibrosis. Sunitinib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the abnormal cells.
Detailed description
PRIMARY OBJECTIVE:
- Assess the response rate and the duration of response in patients with idiopathic myelofibrosis treated with sunitinib malate.
SECONDARY OBJECTIVE:
- Assess the safety of sunitinib malate in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral sunitinib malate once daily for 6 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: sunitinib malatePatients receive oral sunitinib malate once daily for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of MF (histologically confirmed) requiring therapy, including those previously treated and relapsed or refractory (no more than one prior standard acute leukemia-type chemotherapy regimen; no limit on prior MF - directed therapies) or if newly diagnosed, with intermediate or high risk according to Lille scoring system (adverse prognostic factors are: Hb < 10 g/dl, WBC < 4 or > 30 x 10^9/L; risk group: 0 = low, 1 = intermediate, 2 = high), or with symptomatic organomegaly.
- Serum bilirubin levels </= 2x upper limit of the normal (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or MF
- Serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels </= 2x ULN. Higher levels are acceptable if these can be attributed to MF.
- Serum creatinine levels </= 2x ULN.
- Eighteen years of age or older.
Key exclusion criteria (12 listed)
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to beginning treatment or those who have not recovered from treatment-limiting adverse events (to grade 1 or better) due to agents administered more than 4 weeks earlier. At least 4 weeks must have elapsed since any major surgery prior to study enrollment. Continuous use of supportive care medications (i. e. growth factors, anagrelide, or hydroxyurea) is allowed.
- Patients may not be receiving any other investigational agents.
- Patients who have received prior treatment with any other specific antiangiogenic agent (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, PTK787, VEGF Trap, etc.) targeting VEGF/VEGFR system. Other agents that may have some antiangiogenic effects are allowed). (i.e. thalidomide)
- Patients with abnormal QTc prolongation (defined as a QTc interval equal to or greater than 500 msec) or patients who have a history of serious ventricular arrhythmia (VT or VF>/= 3 beats in a row or other significant (as judged by treating physician) ECG abnormalities.Patients with consistently poorly controlled (during the month prior to study screening) hypertension (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher) despite appropriate medical management of the hypertension.
- Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin. Exceptions include: patients using warfarin of up to 2 mg daily for prophylaxis of thrombosis, and patients using low molecular weight heparin provided the patient's INR is </= 1.5.
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 |
|---|---|---|
| sunitinib malateGiven PO | Drug | Arm I |
Primary outcome
Number of Participants With Objective Clinical Response to Sunitinib Therapy
Time frame: After two 6-week treatment courses (12 weeks)
Participant response assessed after two cycles of therapy according to categories: 1) complete response, 2) partial response, 3) clinical improvement, 4) stable disease 5) progressive disease, 6) early death from malignant disease, 7) early death from toxicity, 8) early death because of other cause, or 9) unknown (not assessable, insufficient data).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Srdan Verstovsek principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sunitinib malate in people with Accelerated Phase Chronic Myelogenous Leukemia and Acute Undifferentiated Leukemia, run by National Cancer Institute (NCI) 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 10 inclusion and 12 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 28 May 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Objective Clinical Response to Sunitinib Therapy (time frame: After two 6-week treatment courses (12 weeks)). 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 28 May 2014.