Myeloproliferative DisordersPhase 2NCT01200498
Study of SB939 in Subjects With Myelofibrosis
A Phase 2 study testing SB939 in people with Myeloproliferative Disorders, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if SB939 can help to control myelofibrosis. The safety of this drug will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Disorders
- What is being tested?
- SB939
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Nov 2012
- 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
- Must be equal to or greater than 18 years of age
- Must be diagnosed with Primary Myelofibrosis (PMF) or Post-Essential Thrombocythemia (ET) Myelofibrosis (MF) Post-Polycythemia Vera (PV) MF with intermediate-1, intermediate -2 or high risk disease according to the International Working Group (IWG) prognostic scoring system, or if with low risk disease then with symptomatic splenomegaly that is equal to or greater than 5 cm below left costal margin by physical exam.
- Must have adequate organ function as demonstrated by the following: • alanine aminotransferase (ALT) (SGOT) and/or aspartate aminotransferase (AST) (SGPT) equal to or less than 2.5 times upper limit of normal (ULN), [unless upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis (EMH) related to MF] • Total bilirubin equal to or less than 1.5 times ULN • Serum creatinine equal to or less than 2.5 mg/dL
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
- At least 2 weeks from prior MF-directed treatment (till the start of study drug)
- Treatment-related toxicities from prior therapies must have resolved to Grade equal to or less than 1
- No other active malignancies.
- Females of childbearing potential (a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)).must have negative pregnancy test.
Who cannot join
- Prolongation of the QTc interval to >470 msec at baseline ECG
- Known positive status for HIV, or known active hepatitis A, B, or C infection.
- Any serious medical condition or psychiatric illness that would prevent, (as judged by the treating physician) the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Pregnant or lactating females.
- Current use of drugs known to prolong QTc interval.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Prospective, Open-Label Study to Determine the Safety and Efficacy of SB939, A Histone Deacetylase Inhibitor, in Subjects With Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis (PMF; Post-Polycythemia Vera (PV) Myelofibrosis (MF), Or Post- Essential Thrombosis (ET) MF
The goal of this clinical research study is to learn if SB939 can help to control myelofibrosis. The safety of this drug will also be studied.
Read the detailed description
The Study Drug:
SB939 is designed to change the DNA (genetic material) of cancer cells. This may keep the cells from growing and cause them to die.
This is the first study in which SB939 is given to patients with myelofibrosis.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take SB939 by mouth 3 times a week for the first 3 weeks of every 4-week cycle. In some cases, the study doctor may decide your dose can be raised sometime after Cycle 1.
SB939 can be taken at any time of day, 2 hours before or 2 hours after a meal. You should take SB939 at about the same time each day. Do not open, break, or chew the capsules.
If you have any side effects, the doctor may change the amount or how often you take SB939.
You will fill out a study drug diary to keep track of your SB939 doses. You should bring the diary and all used and unused bottles of study drug with you to every study visit.
Study Visits:
At every study visit, you will be asked about any side effects you have had and any drugs you may be taking.
On Day 1 of Cycle 1 (+/- 3 days):
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about any blood transfusions you have had and drugs you have taken since the last visit.
- Your performance status will be recorded.
- Blood (about 4 teaspoons) will be drawn for routine tests.
- You will have an ECG before taking this medication, about 10 minutes after taking medication, and 4-6 hours after taking medication.
On Day 8 of Cycle 1 (+1-3 days), blood (about 2 teaspoons) will be drawn for routine tests.
On Day 15 of Cycle 1 (+/- 3 days):
- You will have a physical exam, including measurement of your vital signs.
- Blood (about 4 teaspoons) will be drawn for routine tests.
- You will have an ECG before taking this medication, about 10 minutes after taking medication, and 4-6 hours after taking medication.
On Day 22 of Cycle 1 (+1-3 days), blood (about 2 teaspoons) will be drawn for routine tests.
On Day 1 of Cycles 2 and 3 (+/- 3 days):
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about any blood transfusions you have had since the last visit.
- Your performance status will be recorded.
- Blood (about 4 teaspoons) will be drawn for routine tests.
- You will have an ECG.
On Day 1 of Cycles 4 and beyond (+/- 3 days), or every 3 cycles starting on Day 1 of Cycle 6 (+/- 3 days) if the doctor decides your schedule can change (if you have not had serious side effects):
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about any blood transfusions you have had and drugs you have taken since the last visit.
- Your performance status will be recorded.
- Blood (about 4 teaspoons) will be drawn for routine tests.
- You will have a bone marrow biopsy and aspiration to check the status of the disease, if the doctor thinks it is needed.
- You will have an ECG at every visit to MD Anderson.
If your study visit schedule is changed to every 3 cycles (Day 1 of Cycles 6, 9, and so on), blood (about 4 teaspoons) will be drawn for routine tests every 28 days (+/- 3 days). These tests will be done at your local doctor's office. Every 28 days (+/- 3 days), the study staff will also call you to ask how you are doing and if you have had any side effects.
You may have additional bone marrow biopsies and aspirations and ECGs any time the doctor thinks it is needed. The study visits may also occur more often than described above, if the doctor thinks it is needed.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you need radiation therapy, surgery, or other chemotherapy.
Your participation on the study will be over once you have completed the end-of-treatment visit and follow-up.
End-of-Treatment Visit:
After you stop taking the study drug for any reason, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about any blood transfusions you have had and drugs you have taken since the last visit.
- Your performance status will be recorded.
- Blood (about 4 teaspoons) will be drawn for routine tests.
- You will have a bone marrow biopsy and aspiration to check the status of the disease, if the doctor thinks it is needed.
Follow-up:
The study staff will call you 30 days and 60 days after your last dose of the study drug (+/- 3 days). You will be asked how you are doing and if you have had any side effects.
If you have any side effects within 60 days after you stop taking the study drug, you may have extra tests and procedures. For example, blood (about 2 teaspoons) may be drawn for routine tests. If you are still having side effects, the study staff will continue calling you to ask how you are doing until the side effects get better. The schedule for how often you are called will depend on the side effects.
This is an investigational study. SB939 is not FDA approved or commercially available. It is currently being used for research purposes only.
Up to 41 patients will take part in this study. All will be enrolled at the University of Texas (UT) MD Anderson Cancer Center.
- Conditions
- Myeloproliferative Disorders
- Being tested
- SB939
- Keywords
- Primary Polycythemia Vera, Post Polycythemia Vera, Post Essential Thrombocythemia Myelofibrosis, SB939, PMF, post-PV MF, post-ET MF
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB939Drug
Starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SB939 | Experimental | SB939 starting dose 60 mg by mouth every other day, three times weekly for 3 weeks. Receives: Drug: SB939 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With an Objective Response
Objective response defined as Complete, Partial response, and Clinical Improvement based on International Working Group (IWG) Criteria: Complete remission (CR): Absence transfusion \& growth factor support AND Complete resolution disease-related symptoms/signs; Peripheral blood count remission; Normal leukocyte differential; Bone marrow histological remission. Partial remission (PR): All CR except bone marrow histological remission. Clinical improvement (CI): No CR/PR, disease progression with one: ≥2 g/dL increase hemoglobin level or transfusion independent; Either ≥50% reduction in palpable splenomegaly of spleen ≥10 cm baseline or spleen palpable at >5 cm baseline becomes not palpable; ≥100% increase in platelet count \& absolute platelet count ≥50,000 x 10^9/L; or ≥100% increase in absolute neutrophil count (ANC) \& ANC ≥0.5 x 10^9/L. Progressive disease: Progressive splenomegaly or Leukemic transformation confirmed by bone marrow blast of ≥20%; or Increase peripheral blood blast
Measured: Baseline to 3 Cycles (84 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2012
- Study completionNov 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myeloproliferative DisordersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- S*BIO
- Responsible party
- Sponsor
- Investigators
- Alfonso Quintas-Cardama, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200498
- Sponsor's protocol ID
- 2010-0319
- Status last verified
- Dec 2013
- First submitted
- 9 Sep 2010
- Last updated
- 30 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Quintas-Cardama A, Kantarjian H, Estrov Z, Borthakur G, Cortes J, Verstovsek S. Therapy with the histone deacetylase inhibitor pracinostat for patients with myelofibrosis. Leuk Res. 2012 Sep;36(9):1124-7. doi: 10.1016/j.leukres.2012.03.003. Epub 2012 Apr 2.
PubMed 22475363
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Prospective, Open-Label Study to Determine the Safety and Efficacy of SB939, A Histone Deacetylase Inhibitor, in Subjects With Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis (PMF; Post-Polycythemia Vera (PV) Myelofibrosis (MF), Or Post- Essential Thrombosis (ET) MF
- ClinicalTrials.gov ID
- NCT01200498
- Acronym / sponsor ID
- 2010-0319
- Conditions
- Myeloproliferative Disorders
- Keywords
- Primary Polycythemia Vera, Post Polycythemia Vera, Post Essential Thrombocythemia Myelofibrosis, SB939, PMF, post-PV MF, post-ET MF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- S*BIO
- Study start
- Nov 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Posted 30 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if SB939 can help to control myelofibrosis. The safety of this drug will also be studied.
Detailed description
The Study Drug:
SB939 is designed to change the DNA (genetic material) of cancer cells. This may keep the cells from growing and cause them to die.
This is the first study in which SB939 is given to patients with myelofibrosis.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take SB939 by mouth 3 times a week for the first 3 weeks of every 4-week cycle. In some cases, the study doctor may decide your dose can be raised sometime after Cycle 1.
SB939 can be taken at any time of day, 2 hours before or 2 hours after a meal. You should take SB939 at about the same time each day. Do not open, break, or chew the capsules.
If you have any side effects, the doctor may change the amount or how often you take SB939.
You will fill out a study drug diary to keep track of your SB939 doses. You should bring the diary and all used and unused bottles of study drug with you to every study visit.
Study Visits:
At every study visit, you will be asked about any side effects you have had and any drugs you may be taking.
On Day 1 of Cycle 1 (+/- 3 days):
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about any blood transfusions you have had and drugs you have taken since the last visit.
- Your performance status will be recorded.
- Blood (about 4 teaspoons) will be drawn for routine tests.
- You will have an ECG before taking this medication, about 10 minutes after taking medication, and 4-6 hours after taking medication.
On Day 8 of Cycle 1 (+1-3 days), blood (about 2 teaspoons) will be drawn for routine tests.
On Day 15 of Cycle 1 (+/- 3 days):
- You will have a physical exam, including measurement of your vital signs.
- Blood (about 4 teaspoons) will be drawn for routine tests.
- You will have an ECG before taking this medication, about 10 minutes after taking medication, and 4-6 hours after taking medication.
On Day 22 of Cycle 1 (+1-3 days), blood (about 2 teaspoons) will be drawn for routine tests.
On Day 1 of Cycles 2 and 3 (+/- 3 days):
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about any blood transfusions you have had since the last visit.
- Your performance status will be recorded.
- Blood (about 4 teaspoons) will be drawn for routine tests.
- You will have an ECG.
On Day 1 of Cycles 4 and beyond (+/- 3 days), or every 3 cycles starting on Day 1 of Cycle 6 (+/- 3 days) if the doctor decides your schedule can change (if you have not had serious side effects):
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about any blood transfusions you have had and drugs you have taken since the last visit.
- Your performance status will be recorded.
- Blood (about 4 teaspoons) will be drawn for routine tests.
- You will have a bone marrow biopsy and aspiration to check the status of the disease, if the doctor thinks it is needed.
- You will have an ECG at every visit to MD Anderson.
If your study visit schedule is changed to every 3 cycles (Day 1 of Cycles 6, 9, and so on), blood (about 4 teaspoons) will be drawn for routine tests every 28 days (+/- 3 days). These tests will be done at your local doctor's office. Every 28 days (+/- 3 days), the study staff will also call you to ask how you are doing and if you have had any side effects.
You may have additional bone marrow biopsies and aspirations and ECGs any time the doctor thinks it is needed. The study visits may also occur more often than described above, if the doctor thinks it is needed.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you need radiation therapy, surgery, or other chemotherapy.
Your participation on the study will be over once you have completed the end-of-treatment visit and follow-up.
End-of-Treatment Visit:
After you stop taking the study drug for any reason, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about any blood transfusions you have had and drugs you have taken since the last visit.
- Your performance status will be recorded.
- Blood (about 4 teaspoons) will be drawn for routine tests.
- You will have a bone marrow biopsy and aspiration to check the status of the disease, if the doctor thinks it is needed.
Follow-up:
The study staff will call you 30 days and 60 days after your last dose of the study drug (+/- 3 days). You will be asked how you are doing and if you have had any side effects.
If you have any side effects within 60 days after you stop taking the study drug, you may have extra tests and procedures. For example, blood (about 2 teaspoons) may be drawn for routine tests. If you are still having side effects, the study staff will continue calling you to ask how you are doing until the side effects get better. The schedule for how often you are called will depend on the side effects.
This is an investigational study. SB939 is not FDA approved or commercially available. It is currently being used for research purposes only.
Up to 41 patients will take part in this study. All will be enrolled at the University of Texas (UT) MD Anderson Cancer Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SB939 | Experimental | Drug: SB939SB939 starting dose 60 mg by mouth every other day, three times weekly for 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must be equal to or greater than 18 years of age
- Must be diagnosed with Primary Myelofibrosis (PMF) or Post-Essential Thrombocythemia (ET) Myelofibrosis (MF) Post-Polycythemia Vera (PV) MF with intermediate-1, intermediate -2 or high risk disease according to the International Working Group (IWG) prognostic scoring system, or if with low risk disease then with symptomatic splenomegaly that is equal to or greater than 5 cm below left costal margin by physical exam.
- Must have adequate organ function as demonstrated by the following: • alanine aminotransferase (ALT) (SGOT) and/or aspartate aminotransferase (AST) (SGPT) equal to or less than 2.5 times upper limit of normal (ULN), [unless upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis (EMH) related to MF] • Total bilirubin equal to or less than 1.5 times ULN • Serum creatinine equal to or less than 2.5 mg/dL
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
- At least 2 weeks from prior MF-directed treatment (till the start of study drug)
Key exclusion criteria (5 listed)
- Prolongation of the QTc interval to >470 msec at baseline ECG
- Known positive status for HIV, or known active hepatitis A, B, or C infection.
- Any serious medical condition or psychiatric illness that would prevent, (as judged by the treating physician) the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Pregnant or lactating females.
- Current use of drugs known to prolong QTc interval.
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 |
|---|---|---|
| SB939Starting dose 60 mg by mouth every other day, three times weekly for 3 weeks. | Drug | SB939 |
Primary outcome
Participants With an Objective Response
Time frame: Baseline to 3 Cycles (84 days)
Objective response defined as Complete, Partial response, and Clinical Improvement based on International Working Group (IWG) Criteria: Complete remission (CR): Absence transfusion \& growth factor support AND Complete resolution disease-related symptoms/signs; Peripheral blood count remission; Normal leukocyte differential; Bone marrow histological remission. Partial remission (PR): All CR except bone marrow histological remission. Clinical improvement (CI): No CR/PR, disease progression with one: ≥2 g/dL increase hemoglobin level or transfusion independent; Either ≥50% reduction in palpable splenomegaly of spleen ≥10 cm baseline or spleen palpable at >5 cm baseline becomes not palpable; ≥100% increase in platelet count \& absolute platelet count ≥50,000 x 10^9/L; or ≥100% increase in absolute neutrophil count (ANC) \& ANC ≥0.5 x 10^9/L. Progressive disease: Progressive splenomegaly or Leukemic transformation confirmed by bone marrow blast of ≥20%; or Increase peripheral blood blast
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22475363Quintas-Cardama A, Kantarjian H, Estrov Z, Borthakur G, Cortes J, Verstovsek S. Therapy with the histone deacetylase inhibitor pracinostat for patients with myelofibrosis. Leuk Res. 2012 Sep;36(9):1124-7. doi: 10.1016/j.leukres.2012.03.003. Epub 2012 Apr 2.
- UT MD Anderson Cancer Center official websiteLink provided by the sponsor.
Related trials for Myeloproliferative Disorders
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
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.
Alfonso Quintas-Cardama, MD principal investigator
UT MD 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 SB939 in people with Myeloproliferative Disorders, run by M.D. Anderson Cancer Center 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 8 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 30 Jan 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 30 Jan 2014). 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?
Participants With an Objective Response (time frame: Baseline to 3 Cycles (84 days)). 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 NCT01200498, 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 Jan 2014.