MyelofibrosisPhase 1NCT03373877
Evaluation of Ruxolitinib in Combination With PU-H71 for Treatment of Myelofibrosis
A Phase 1 study testing PU-H71 and Ruxolitinib in people with Myelofibrosis and Primary Myelofibrosis, run by Samus Therapeutics, Inc. at 10 sites in United States.
Trial summary
This is a multicenter 2-part, Phase 1b study designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of PU-H71 in subjects taking concomitant ruxolitinib. The first part (Dose Escalation) will employ a standard 3+3 dose escalation design to determine Maximum Tolerated Dose (MTD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis
- What is being tested?
- PU-H71 and Ruxolitinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 10 sitesUnited States
- Study dates
- 24 May 2018to 10 Mar 2020
- 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
- Subject has a confirmed diagnosis of myelofibrosis, including PMF, post-PV MF, and post-ET MF.
- Subject has been receiving ruxolitinib therapy for intermediate or high-risk myelofibrosis for >6 months prior to enrollment with no more than 1 dose reduction of ruxolitinib in the 2-8 weeks prior to enrollment and a stable daily dose ≥5 mg twice daily (BID) >2 months prior to enrollment.
- Subject has MF with evidence of persistent disease despite ruxolitinib monotherapy treatment, consisting of:
- Persistent or worsening disease-related symptoms, including but not limited to fatigue, pruritus, night sweats, early satiety, and other symptoms as determined by a MPN-SAF TSS score of >20 points; AND
- Documented splenomegaly of at least 5 cm below the costal margin as measured on inspiration by physical exam.
- Subject has an Eastern Cooperative Oncology Group performance status of 0-2.
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- Acceptable pre-study organ function during screening defined as:
- Absolute neutrophil count (ANC) ≥ 1000/uL
- Hemoglobin (hgb) ≥ 8.0 g/dL (may be supported with transfusion)
- Platelets (plt) ≥ 75,000/uL
- AST/SGOT and ALT/SGPT ≤2 x Upper Limit of Normal (ULN)
- Direct serum bilirubin ≤ 1.5 x ULN
- Creatinine clearance >50 mL/min/1.73 m2 based on Cockcroft Gault equation.
Who cannot join
- Subject has known active liver disease, including viral hepatitis or cirrhosis.
- Subject has known or suspected HIV or other active infections requiring acute or chronic treatment with systemic antibiotics. Conditions requiring topical antibiotics are acceptable.
- Subject has a QTcF > 480 ms (corrected) in the screening or baseline ECG.
- Subject has left ventricular ejection fraction (LVEF) ≤ 50%, or below institution's lower limit of normal (whichever is lower) by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
- Subject has a history (or family history) of long QT syndrome.
- Subject has coronary artery disease with an ischemic event within 6 months prior to enrollment.
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- Subject has a permanent cardiac pacemaker.
- Subject has history of a second primary malignancy within the past 2 year except for the following (if appropriately treated and considered cured): stage I endometrial, surgically treated cervical or prostate carcinoma, and non-melanoma skin cancer.
- Subject has significant uncontrolled medical condition within 6 months prior to enrollment, as determined by the investigator.
- Subject has concurrent participation in any interventional studies within 14 days of first dose of study drug.
- Subject has uncontrolled diabetes mellitus, in the judgment of the Principal Investigator.
- Subject has an active ocular condition that in the opinion of the investigator may alter visual acuity during the course of the study (i.e., ocular inflammatory disease etc.) or a history or anticipation of major ocular surgery (including cataract extraction, intraocular surgery, etc.) during the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Michigan
Ann Arbor, Michigan, 48109
Cleveland Clinic - Taussig Cancer Institute
Cleveland, Ohio, 44195
Karmanos Cancer Institute
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
Yale Cancer Center
New Haven, Connecticut, 06511
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Abramson Cancer Center - University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mays Cancer Center UT Health San Antonio
San Antonio, Texas, 78229-3900
About this study
Official title: A Phase Ib Study of Ruxolitinib in Combination With PU-H71 for the Treatment of Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV MF), and Post-EssentialThrombocythemia MF (Post-ET MF)
This is a multicenter 2-part, Phase 1b study designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of PU-H71 in subjects taking concomitant ruxolitinib. The first part (Dose Escalation) will employ a standard 3+3 dose escalation design to determine Maximum Tolerated Dose (MTD). The second part of the study (Dose Confirmation) will confirm the recommended Phase 2 dose (RP2D) in an expanded population.
Read the detailed description
This is a multicenter 2-part, Phase 1b study designed to assess the safety, tolerability, PK and preliminary efficacy of PU-H71 (dihydrochloride salt) in subjects taking concomitant ruxolitinib. The first part (Dose Escalation) will employ a standard 3+3 dose escalation design to determine MTD. The second part of the study (Dose Confirmation) will confirm the RP2D in an expanded population.
Up to 30 subjects who have active disease despite having received a minimum of 6 months of ruxolitinib therapy (including last 2 months at a daily dose of ≥5 mg twice daily and no more than one dose reduction 2-8 weeks prior to the baseline visit)stable dose will be enrolled to evaluate the safety, PK, and MTD of IV PU-H71 administered in combination ruxolitinib. Four ascending dose levels are planned. The planned dose levels of PU-H71 are 225 mg/m2, 300 mg/m2, 400 mg/m2, and 600 mg/m2. Additional dosing cohorts may be added at the discretion of the Safety Review Committee (SRC).
Following a 28-day screening period, eligible subjects will receive PU-H71 once weekly intravenously for three consecutive weeks, followed by one week off on a 28-day cycle (D1, D8, D15, every 28 days). Ruxolitinib will be administered twice daily per the package insert at the stable dose the subject had been receiving prior to enrolling in the study.
Subjects will have pk samples taken and ECGs performed at various time points throughout the study. Subjects will have safety evaluations including physical examinations, vital signs, laboratory assessments, and AE reporting. If deemed necessary, additional safety measurements will be performed at the discretion of the Investigator or the SRC.
Subjects will be treated until disease progression, DLT, death, or study termination.
At each dose level, a 3+3 dose escalation design will be employed. If none of the initial 3 subjects in the cohort experience a DLT within the first cycle, a new cohort of 3 subjects will be treated at the next higher dose level. If 1 of the 3 subjects in a cohort experiences a DLT, then 3 additional subjects will be treated at the same dose level as described under Dose Limiting Toxicities.
Once the MTD has been determined in the dose escalation portion of the study, up to 15 patients may be enrolled for further evaluation of safety, PK, and preliminary clinical activity in a dose confirmation phase.
A safety review committee (SRC) will assess the safety, tolerability, and available PK information collected for each dose level, decide whether to proceed to the next cohort, and determine the dose for the cohort.
- Conditions
- Myelofibrosis, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
- Being tested
- PU-H71, Ruxolitinib
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PU-H71Drug
PU-H71 treatments will be administered by IV infusion on days 1, 8, and 15 of each 28-day cycle.
RuxolitinibDrug
Also called Jakafi
Dosing will be in accordance with current package insert and dose subject was on during study entry.
| Study group | Role | What they receive |
|---|---|---|
| Dose 1: PU-H71 225 mg/m2 + ruxolitinib | Experimental | Cohort 1 Receives: Drug: PU-H71; Drug: Ruxolitinib |
| Dose 2: PU-H71 300 mg/m2 + ruxolitinib | Experimental | Cohort 2 Receives: Drug: PU-H71; Drug: Ruxolitinib |
| Dose 3: PU-H71 400 mg/m2 + ruxolitinib | Experimental | Cohort 3 Receives: Drug: PU-H71; Drug: Ruxolitinib |
| Dose 4: PU-H71 600 mg/m2 + ruxolitinib | Experimental | Cohort 4 Receives: Drug: PU-H71; Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Safety of PU-H71 in combination with ruxolitinib as assessed by the incidence and severity of adverse events (AEs) and serious AEs as determined by the NCI CTCAE v4.03.
Measured: 12 months
Maximum Tolerated Dose of PU-H71 (MTD)
MTD as assessed by the occurrences of dose limiting toxicities of PU-H71 in combination with ruxolitinib. The MTD will be defined as the dose that does not exceed an acceptable threshold of toxicity.
Measured: 7 months
Recommended Phase 2 Dose of PU-H71 (RP2D)
The RP2D is the dose with an acceptable risk/benefit ratio that warrant study in future trials
Measured: 12 months
Pharmacokinetic profile of PU-H71: Area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC)
Measured: 12 months
Pharmacokinetic profile of PU-H71: Trough plasma concentration (Cmin)
Trough plasma concentration (Cmin)
Measured: 12 months
Pharmacokinetic profile of PU-H71: Peak plasma concentration (Cmax)
Peak plasma concentration (Cmax)
Measured: 12 months
Pharmacokinetic profile of PU-H71: Time to maximum plasma concentration (Tmax)
Time to maximum plasma concentration (Tmax)
Measured: 12 months
Pharmacokinetic profile of PU-H71: Plasma half-life (T1/2)
Plasma half-life (T1/2)
Measured: 12 months
Secondary outcomes (3)
Treatment Response
Treatment response is to be evaluated using the revised IWG-MRT response criteria.
Measured: 12 months
Symptom Burden Assessment
The symptomatic burden will be serially evaluated using the MPN-SAF TSS.
Measured: 12 months
Biological Markers
Assess the effects of treatment on biological markers of the disease (i.e., bone marrow histology; JAK2V617F, CALR, or MPLW515L/K allele burden; cytogenetic response; serum cytokine profiles; and other biomarkers of disease activity).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start24 May 2018
- Primary completion17 Oct 2019
- Study completion10 Mar 2020
Why it stopped: Samus is focusing all of their efforts in myelofibrosis on the new oral formulation of PU-H71.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Morgan, MS, JD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373877
- Sponsor's protocol ID
- PU-H71-01-002
- Status last verified
- Nov 2022
- First submitted
- 29 Nov 2017
- Last updated
- 15 Nov 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 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of Ruxolitinib in Combination With PU-H71 for the Treatment of Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV MF), and Post-EssentialThrombocythemia MF (Post-ET MF)
- ClinicalTrials.gov ID
- NCT03373877
- Acronym / sponsor ID
- PU-H71-01-002
- Conditions
- Myelofibrosis, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Samus is focusing all of their efforts in myelofibrosis on the new oral formulation of PU-H71.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Samus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 May 2018 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 14 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.
This is a multicenter 2-part, Phase 1b study designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of PU-H71 in subjects taking concomitant ruxolitinib. The first part (Dose Escalation) will employ a standard 3+3 dose escalation design to determine Maximum Tolerated Dose (MTD). The second part of the study (Dose Confirmation) will confirm the recommended Phase 2 dose (RP2D) in an expanded population.
Detailed description
This is a multicenter 2-part, Phase 1b study designed to assess the safety, tolerability, PK and preliminary efficacy of PU-H71 (dihydrochloride salt) in subjects taking concomitant ruxolitinib. The first part (Dose Escalation) will employ a standard 3+3 dose escalation design to determine MTD. The second part of the study (Dose Confirmation) will confirm the RP2D in an expanded population.
Up to 30 subjects who have active disease despite having received a minimum of 6 months of ruxolitinib therapy (including last 2 months at a daily dose of ≥5 mg twice daily and no more than one dose reduction 2-8 weeks prior to the baseline visit)stable dose will be enrolled to evaluate the safety, PK, and MTD of IV PU-H71 administered in combination ruxolitinib. Four ascending dose levels are planned. The planned dose levels of PU-H71 are 225 mg/m2, 300 mg/m2, 400 mg/m2, and 600 mg/m2. Additional dosing cohorts may be added at the discretion of the Safety Review Committee (SRC).
Following a 28-day screening period, eligible subjects will receive PU-H71 once weekly intravenously for three consecutive weeks, followed by one week off on a 28-day cycle (D1, D8, D15, every 28 days). Ruxolitinib will be administered twice daily per the package insert at the stable dose the subject had been receiving prior to enrolling in the study.
Subjects will have pk samples taken and ECGs performed at various time points throughout the study. Subjects will have safety evaluations including physical examinations, vital signs, laboratory assessments, and AE reporting. If deemed necessary, additional safety measurements will be performed at the discretion of the Investigator or the SRC.
Subjects will be treated until disease progression, DLT, death, or study termination.
At each dose level, a 3+3 dose escalation design will be employed. If none of the initial 3 subjects in the cohort experience a DLT within the first cycle, a new cohort of 3 subjects will be treated at the next higher dose level. If 1 of the 3 subjects in a cohort experiences a DLT, then 3 additional subjects will be treated at the same dose level as described under Dose Limiting Toxicities.
Once the MTD has been determined in the dose escalation portion of the study, up to 15 patients may be enrolled for further evaluation of safety, PK, and preliminary clinical activity in a dose confirmation phase.
A safety review committee (SRC) will assess the safety, tolerability, and available PK information collected for each dose level, decide whether to proceed to the next cohort, and determine the dose for the cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose 1: PU-H71 225 mg/m2 + ruxolitinib | Experimental | Drug: PU-H71, Drug: RuxolitinibCohort 1 |
| Dose 2: PU-H71 300 mg/m2 + ruxolitinib | Experimental | Drug: PU-H71, Drug: RuxolitinibCohort 2 |
| Dose 3: PU-H71 400 mg/m2 + ruxolitinib | Experimental | Drug: PU-H71, Drug: RuxolitinibCohort 3 |
| Dose 4: PU-H71 600 mg/m2 + ruxolitinib | Experimental | Drug: PU-H71, Drug: RuxolitinibCohort 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject has a confirmed diagnosis of myelofibrosis, including PMF, post-PV MF, and post-ET MF.
- Subject has been receiving ruxolitinib therapy for intermediate or high-risk myelofibrosis for >6 months prior to enrollment with no more than 1 dose reduction of ruxolitinib in the 2-8 weeks prior to enrollment and a stable daily dose ≥5 mg twice daily (BID) >2 months prior to enrollment.
- Subject has MF with evidence of persistent disease despite ruxolitinib monotherapy treatment, consisting of:
- Subject has an Eastern Cooperative Oncology Group performance status of 0-2.
- Acceptable pre-study organ function during screening defined as:
Key exclusion criteria (12 listed)
- Subject has known active liver disease, including viral hepatitis or cirrhosis.
- Subject has known or suspected HIV or other active infections requiring acute or chronic treatment with systemic antibiotics. Conditions requiring topical antibiotics are acceptable.
- Subject has a QTcF > 480 ms (corrected) in the screening or baseline ECG.
- Subject has left ventricular ejection fraction (LVEF) ≤ 50%, or below institution's lower limit of normal (whichever is lower) by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
- Subject has a history (or family history) of long QT syndrome.
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 |
|---|---|---|
| PU-H71PU-H71 treatments will be administered by IV infusion on days 1, 8, and 15 of each 28-day cycle. | Drug | Dose 1: PU-H71 225 mg/m2 + ruxolitinib, Dose 2: PU-H71 300 mg/m2 + ruxolitinib, Dose 3: PU-H71 400 mg/m2 + ruxolitinib, Dose 4: PU-H71 600 mg/m2 + ruxolitinib |
| RuxolitinibAlso: JakafiDosing will be in accordance with current package insert and dose subject was on during study entry. | Drug | Dose 1: PU-H71 225 mg/m2 + ruxolitinib, Dose 2: PU-H71 300 mg/m2 + ruxolitinib, Dose 3: PU-H71 400 mg/m2 + ruxolitinib, Dose 4: PU-H71 600 mg/m2 + ruxolitinib |
Primary outcome
Incidence of adverse events
Time frame: 12 months
Safety of PU-H71 in combination with ruxolitinib as assessed by the incidence and severity of adverse events (AEs) and serious AEs as determined by the NCI CTCAE v4.03.
Maximum Tolerated Dose of PU-H71 (MTD)
Time frame: 7 months
MTD as assessed by the occurrences of dose limiting toxicities of PU-H71 in combination with ruxolitinib. The MTD will be defined as the dose that does not exceed an acceptable threshold of toxicity.
Recommended Phase 2 Dose of PU-H71 (RP2D)
Time frame: 12 months
The RP2D is the dose with an acceptable risk/benefit ratio that warrant study in future trials
Pharmacokinetic profile of PU-H71: Area under the plasma concentration versus time curve (AUC)
Time frame: 12 months
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetic profile of PU-H71: Trough plasma concentration (Cmin)
Time frame: 12 months
Trough plasma concentration (Cmin)
Pharmacokinetic profile of PU-H71: Peak plasma concentration (Cmax)
Time frame: 12 months
Peak plasma concentration (Cmax)
Pharmacokinetic profile of PU-H71: Time to maximum plasma concentration (Tmax)
Time frame: 12 months
Time to maximum plasma concentration (Tmax)
Pharmacokinetic profile of PU-H71: Plasma half-life (T1/2)
Time frame: 12 months
Plasma half-life (T1/2)
3 secondary outcomes
Treatment Response
Time frame: 12 months
Symptom Burden Assessment
Time frame: 12 months
Biological Markers
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Samus is focusing all of their efforts in myelofibrosis on the new oral formulation of PU-H71.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Robert Morgan, MS, JD study director
Sponsor GmbH
10 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 PU-H71 and Ruxolitinib in people with Myelofibrosis and Primary Myelofibrosis, run by Samus Therapeutics, Inc. at 10 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 13 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 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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: Samus is focusing all of their efforts in myelofibrosis on the new oral formulation of PU-H71.). 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?
Incidence of adverse events (time frame: 12 months). The study lists 8 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 15 Nov 2022.