MyelofibrosesPhase 1NCT03386214
Pevonedistat in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis
A Phase 1 study testing Pevonedistat, Ruxolitinib and Peripheral blood draw in people with Myelofibroses, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Based on the investigators' preclinical data, the combination of pevonedistat and ruxolitinib may provide greater clinical responses in patients with myelofibrosis compared to ruxolitinib monotherapy via inhibition of NFκB in addition to JAK-STAT signaling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibroses
- What is being tested?
- Pevonedistat, Ruxolitinib and Peripheral blood draw
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2018to 4 Oct 2021
- 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 primary myelofibrosis or post-polycythemia vera/essential thrombocythemia myelofibrosis classified as high risk, intermediate-2 risk, or intermediate 1 risk by IPSS.
- On treatment with ruxolitinib for at least 3 months and have been on a stable dose for at least 8 weeks and have not achieved a CR by IWG criteria.
- At least 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Adequate bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 500/mcL, and have not received any growth factor support for at least 4 weeks prior to screening
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- Platelets ≥ 50,000/mcL
- Peripheral blood blasts ≤ 10%
- Albumin > 2.7 g/dL
- Total bilirubin ≤ institutional upper limit of normal (IULN); patients with Gilbert's syndrome may enroll if direct bilirubin ≤ 1.5 x IULN
- ALT and AST ≤ 2.5 x IULN
- Creatinine clearance ≥ 50 mL/min
- Female patients who:
- Are postmenopausal for at least 1 year before the screening visit, OR
- Are surgically sterile, OR
- If they are of childbearing potential:
- Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), OR
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)
- Male patients, even if surgically sterilized (ie, status postvasectomy), who:
- Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (female and male condoms should not be used together), OR
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)
Who cannot join
- History of allogeneic stem cell transplant.
- Major surgery within 14 days before the first dose of any study drug or a scheduled surgery during the study period.
- Received hydroxyurea therapy within 28 days (4 weeks) before the first dose of any study drug.
- Systemic antineoplastic therapy or radiotherapy for other malignant conditions within 14 days before the first dose of any study drug.
- Currently receiving any other investigational agents.
- Treatment with clinically significant metabolic enzyme inducers within 14 days before the first dose of study drug. Clinically significant metabolic enzyme inducers are not permitted during the study.
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- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to pevonedistat, ruxolitinib, or other agents used in the study.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study procedures.
- Diagnosis or treated for another malignancy within 2 years before enrollment, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any time are not excluded if they have undergone resection.
- Ongoing or active infection.
- Known cardiopulmonary disease defined as:
- Unstable angina pectoris
- Congestive heart failure (NYHA class III or IV)
- Myocardial infarction within 6 months prior to first dose (patients who had ischemic heart disease such as ACS, MI, and/or revascularization more than 6 months prior to enrollment and who are without cardiac symptoms may enroll)
- Symptomatic cardiomyopathy
- Clinically significant cardiac arrhythmia
- History of polymorphic ventricular fibrillation or Torsade de Pointes
- Permanent atrial fibrillation (a fib), defined as continuous a fib for ≥ 6 months
- Persistent a fib, defined as sustained a fib lasting > 7 days and/or requiring cardioversion in the 4 weeks before screening
- Grade 3 a fib defined as symptomatic and incompletely controlled medically, or controlled with device (e.g. pacemaker) or ablation. Patients with Paroxysmal a fib or < grade 3 a fib for a period of at least 6 months are permitted to enroll provided that their rate is controlled on a stable regimen.
- Implantable cardioverter defibrillator
- Moderate to severe aortic and/or mitral stenosis or other valvulopathy (ongoing)
- Clinically significant pulmonary hypertension requiring pharmacologic therapy
- Uncontrolled coagulopathy or bleeding disorder.
- Uncontrolled high blood pressure (i.e. systolic blood pressure > 180 mmHg, diastolic blood pressure > 95 mmHg).
- Prolonged rate corrected QT (QTc) interval ≥ 500 msec, calculated according to institutional guidelines.
- Left ventricular ejection fraction (LVEF) < 50% as assessed by echocardiogram or radionuclide angiography.
- Known moderate to severe chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary fibrosis.
- Known hepatic cirrhosis or severe pre-existing hepatic impairment.
- Known CNS involvement.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- Female patients who intend to donate eggs and male patients who intended to donate sperm during the course of this study or for 4 months after receiving the last dose of study treatment.
- Female patients who are both lactating and breastfeeding or have positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug
- Known HIV-positivity.
- Chronic, active, or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier.
- Life-threatening illness unrelated to cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Based on the investigators' preclinical data, the combination of pevonedistat and ruxolitinib may provide greater clinical responses in patients with myelofibrosis compared to ruxolitinib monotherapy via inhibition of NFκB in addition to JAK-STAT signaling.
- Conditions
- Myelofibroses
- Being tested
- Pevonedistat, Ruxolitinib, Peripheral blood draw, Skin biopsy
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PevonedistatDrug
Also called MLN4924
The amount of pevonedistat to be administered will be based on body surface area (BSA). BSA will be calculated using a standard formula on Cycle 1 Day 1, and on Day 1 of subsequent cycles if the patient experiences a > 5% change in body weight from the weight used for the most recent BSA calculation.
RuxolitinibDrug
Also called Jakavi®
-Standard of care outside of protocol
Peripheral blood drawProcedure or surgery
- Baseline or Cycle 1 Day 1 (prior to study treatment administration)
- Cycle 2 Day 1 (prior to study treatment administration)
- Cycle 4 Day 1 (prior to study treatment administration)
- End of treatment
Skin biopsyProcedure or surgery
A skin punch biopsy specimen will be collected at the baseline visit. One 6 mm punch biopsy of normal skin will be performed using standard techniques and local anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Starting Dose - 5 mg/m^2 pevonedistat + ruxolitinib | Experimental | * Pevonedistat will be given as an IV infusion at the assigned dose over the course of 60 minutes on Days 1, 3, and 5 of each 28-day cycle.
* Ruxolitinib will be continued at the same dose as prior to enrollment and will be administered as standard of care outside the study protocol. Receives: Drug: Pevonedistat; Drug: Ruxolitinib; Procedure: Peripheral blood draw; Procedure: Skin biopsy |
| Arm 2: Dose Level 2 - 10 mg/m^2 pevonedistat + ruxolitinib | Experimental | * Pevonedistat will be given as an IV infusion at the assigned dose over the course of 60 minutes on Days 1, 3, and 5 of each 28-day cycle.
* Ruxolitinib will be continued at the same dose as prior to enrollment and will be administered as standard of care outside the study protocol. Receives: Drug: Pevonedistat; Drug: Ruxolitinib; Procedure: Peripheral blood draw; Procedure: Skin biopsy |
| Arm 3: Dose Level 3 - 20 mg/m^2 pevonedistat + ruxolitinib | Experimental | * Pevonedistat will be given as an IV infusion at the assigned dose over the course of 60 minutes on Days 1, 3, and 5 of each 28-day cycle.
* Ruxolitinib will be continued at the same dose as prior to enrollment and will be administered as standard of care outside the study protocol. Receives: Drug: Pevonedistat; Drug: Ruxolitinib; Procedure: Peripheral blood draw; Procedure: Skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of pevonedistat in combination with ruxolitinib in patients with myelofibrosis as measured by the frequency of adverse events
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Measured: Through 30 days after completion of treatment (estimated to be 42 weeks)
Safety and tolerability of pevonedistat in combination with ruxolitinib in patients with myelofibrosis as measured by the maximum tolerated dose (MTD)
-MTD: The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. Dose escalations will proceed until the MTD has been reached.
Measured: 28 days after enrollment of last participant (estimated to be 25 months)
Secondary outcomes (7)
Spleen response with the combination of pevonedistat and ruxolitinib
- A baseline splenomegaly that is palpable at 5-10 cm below the left costal margin becomes not palpable OR
- A baseline splenomegaly that is palpable > 10 cm below the left costal margin decreases by ≥50% OR
- A baseline splenomegaly that is palpable < 5 cm below the left costal margin is not eligible for spleen response OR
- Ultrasound shows ≥35% spleen volume reduction (calculated)
Measured: Through 12 weeks after completion of treatment (estimated to be 48 weeks)
Improvement of constitutional symptoms with the combination of pevonedistat and ruxolitinib
- A ≥50% reduction in the myeloproliferative neoplasm symptom assessment total symptom score
- 8 symptoms (tiredness, early satiety, abdominal discomfort, inactivity, night sweats, itching, bone pain, pain under ribs under left side) with 0 to 10 ranking where 0=no pain and 10=worst imaginable pain
Measured: Through completion of treatment (estimated to be 36 weeks)
Hematologic response with the combination of pevonedistat and ruxolitinib as measured by anemia response
-Anemia response is only applicable for patients with a baseline hemoglobin level less than 10g/dL for 8 weeks or more, and requires:
- ≥ 2 g/dL increase in hemoglobin level OR
- becoming transfusion-independent (no RBC transfusions in past 1 month)
Measured: Through 12 weeks after completion of treatment (estimated to be 48 weeks)
Hematologic response with the combination of pevonedistat and ruxolitinib as measured by platelet response
-Platelet response is only applicable for patients with a baseline platelet count of less than 50 x 109/L for 8 weeks or more, and requires:
- 100% increase in platelet count AND
- An absolute platelet count of at least 50 x 109/L
Measured: Through 12 weeks after completion of treatment (estimated to be 48 weeks)
Pharmacokinetics of pevonedistat when co-administered with ruxolitinib as measured by the Cmax (peak serum concentration)
Measured: Through Cycle 1 Day 5
Pharmacokinetics of pevonedistat when co-administered with ruxolitinib as measured by the Tmax (time of maximum concentration observed)
Measured: Through Cycle 1 Day 5
Pharmacokinetics of pevonedistat when co-administered with ruxolitinib as measured by the area under the plasma drug concentration curve (AUC)
-AUC reflects the actual body exposure to drug after administration of a dose of the drug and is expressed
Measured: At 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start23 Apr 2018
- Primary completion12 Sep 2021
- Study completion4 Oct 2021
Why it stopped: Sponsor stopped development of pevonedistat
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
- Investigators
- Stephen Oh, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386214
- Sponsor's protocol ID
- 201802152
- Other IDs
- IISR-2017-101916
- Status last verified
- Dec 2021
- First submitted
- 21 Dec 2017
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pevonedistat in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis
- ClinicalTrials.gov ID
- NCT03386214
- Acronym / sponsor ID
- 201802152
- Conditions
- Myelofibroses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor stopped development of pevonedistat
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 12 Sep 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 29 Dec 2017 (actual)
- 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.
Based on the investigators' preclinical data, the combination of pevonedistat and ruxolitinib may provide greater clinical responses in patients with myelofibrosis compared to ruxolitinib monotherapy via inhibition of NFκB in addition to JAK-STAT signaling.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Starting Dose - 5 mg/m^2 pevonedistat + ruxolitinib | Experimental | Drug: Pevonedistat, Drug: Ruxolitinib, Procedure: Peripheral blood draw, Procedure: Skin biopsy* Pevonedistat will be given as an IV infusion at the assigned dose over the course of 60 minutes on Days 1, 3, and 5 of each 28-day cycle. * Ruxolitinib will be continued at the same dose as prior to enrollment and will be administered as standard of care outside the study protocol. |
| Arm 2: Dose Level 2 - 10 mg/m^2 pevonedistat + ruxolitinib | Experimental | Drug: Pevonedistat, Drug: Ruxolitinib, Procedure: Peripheral blood draw, Procedure: Skin biopsy* Pevonedistat will be given as an IV infusion at the assigned dose over the course of 60 minutes on Days 1, 3, and 5 of each 28-day cycle. * Ruxolitinib will be continued at the same dose as prior to enrollment and will be administered as standard of care outside the study protocol. |
| Arm 3: Dose Level 3 - 20 mg/m^2 pevonedistat + ruxolitinib | Experimental | Drug: Pevonedistat, Drug: Ruxolitinib, Procedure: Peripheral blood draw, Procedure: Skin biopsy* Pevonedistat will be given as an IV infusion at the assigned dose over the course of 60 minutes on Days 1, 3, and 5 of each 28-day cycle. * Ruxolitinib will be continued at the same dose as prior to enrollment and will be administered as standard of care outside the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Confirmed diagnosis of primary myelofibrosis or post-polycythemia vera/essential thrombocythemia myelofibrosis classified as high risk, intermediate-2 risk, or intermediate 1 risk by IPSS.
- On treatment with ruxolitinib for at least 3 months and have been on a stable dose for at least 8 weeks and have not achieved a CR by IWG criteria.
- At least 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Adequate bone marrow and organ function as defined below:
Key exclusion criteria (36 listed)
- History of allogeneic stem cell transplant.
- Major surgery within 14 days before the first dose of any study drug or a scheduled surgery during the study period.
- Received hydroxyurea therapy within 28 days (4 weeks) before the first dose of any study drug.
- Systemic antineoplastic therapy or radiotherapy for other malignant conditions within 14 days before the first dose of any study drug.
- Currently receiving any other investigational agents.
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 |
|---|---|---|
| PevonedistatAlso: MLN4924The amount of pevonedistat to be administered will be based on body surface area (BSA). BSA will be calculated using a standard formula on Cycle 1 Day 1, and on Day 1 of subsequent cycles if the patient experiences a > 5% change in body weight from the weight used for the most recent BSA calculation. | Drug | Arm 1: Starting Dose - 5 mg/m^2 pevonedistat + ruxolitinib, Arm 2: Dose Level 2 - 10 mg/m^2 pevonedistat + ruxolitinib, Arm 3: Dose Level 3 - 20 mg/m^2 pevonedistat + ruxolitinib |
| RuxolitinibAlso: Jakavi®-Standard of care outside of protocol | Drug | Arm 1: Starting Dose - 5 mg/m^2 pevonedistat + ruxolitinib, Arm 2: Dose Level 2 - 10 mg/m^2 pevonedistat + ruxolitinib, Arm 3: Dose Level 3 - 20 mg/m^2 pevonedistat + ruxolitinib |
| Peripheral blood draw* Baseline or Cycle 1 Day 1 (prior to study treatment administration) * Cycle 2 Day 1 (prior to study treatment administration) * Cycle 4 Day 1 (prior to study treatment administration) * End of treatment | Procedure or surgery | Arm 1: Starting Dose - 5 mg/m^2 pevonedistat + ruxolitinib, Arm 2: Dose Level 2 - 10 mg/m^2 pevonedistat + ruxolitinib, Arm 3: Dose Level 3 - 20 mg/m^2 pevonedistat + ruxolitinib |
| Skin biopsyA skin punch biopsy specimen will be collected at the baseline visit. One 6 mm punch biopsy of normal skin will be performed using standard techniques and local anesthesia. | Procedure or surgery | Arm 1: Starting Dose - 5 mg/m^2 pevonedistat + ruxolitinib, Arm 2: Dose Level 2 - 10 mg/m^2 pevonedistat + ruxolitinib, Arm 3: Dose Level 3 - 20 mg/m^2 pevonedistat + ruxolitinib |
Primary outcome
Safety and tolerability of pevonedistat in combination with ruxolitinib in patients with myelofibrosis as measured by the frequency of adverse events
Time frame: Through 30 days after completion of treatment (estimated to be 42 weeks)
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Safety and tolerability of pevonedistat in combination with ruxolitinib in patients with myelofibrosis as measured by the maximum tolerated dose (MTD)
Time frame: 28 days after enrollment of last participant (estimated to be 25 months)
-MTD: The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. Dose escalations will proceed until the MTD has been reached.
7 secondary outcomes
Spleen response with the combination of pevonedistat and ruxolitinib
Time frame: Through 12 weeks after completion of treatment (estimated to be 48 weeks)
Improvement of constitutional symptoms with the combination of pevonedistat and ruxolitinib
Time frame: Through completion of treatment (estimated to be 36 weeks)
Hematologic response with the combination of pevonedistat and ruxolitinib as measured by anemia response
Time frame: Through 12 weeks after completion of treatment (estimated to be 48 weeks)
Hematologic response with the combination of pevonedistat and ruxolitinib as measured by platelet response
Time frame: Through 12 weeks after completion of treatment (estimated to be 48 weeks)
Pharmacokinetics of pevonedistat when co-administered with ruxolitinib as measured by the Cmax (peak serum concentration)
Time frame: Through Cycle 1 Day 5
Pharmacokinetics of pevonedistat when co-administered with ruxolitinib as measured by the Tmax (time of maximum concentration observed)
Time frame: Through Cycle 1 Day 5
Pharmacokinetics of pevonedistat when co-administered with ruxolitinib as measured by the area under the plasma drug concentration curve (AUC)
Time frame: At 24 hours
Results and safety
The study was stopped early (reason given: Sponsor stopped development of pevonedistat). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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RecruitingPhase 3
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Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
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Not yet recruitingPhase 1
Maintenance Treatment With Imetelstat in Patients With High-Risk Myeloid Neoplasms After Allo-SCT
High-risk Myeloid Malignancy, Allogenic Stem Cell Transplantation
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.
Stephen Oh, M.D., Ph.D. principal investigator
Washington University School of Medicine
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 Pevonedistat, Ruxolitinib and Peripheral blood draw in people with Myelofibroses, run by Washington University School of Medicine 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 22 inclusion and 36 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 6 Jan 2022. 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: Sponsor stopped development of pevonedistat). 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?
Safety and tolerability of pevonedistat in combination with ruxolitinib in patients with myelofibrosis as measured by the frequency of adverse events (time frame: Through 30 days after completion of treatment (estimated to be 42 weeks)). The study lists 2 primary outcomes in all. 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 6 Jan 2022.