Multiple MyelomaPhase 1/2ABC-103NCT02757326
ABC294640 (Opaganib) in Refractory / Relapsed Multiple Myeloma
A Phase 1/2 study testing Opaganib in people with Multiple Myeloma, run by RedHill Biopharma Limited at 1 site in United States.
Trial summary
This is a Phase Ib/II safety and efficacy trial of single agent ABC294640, an inhibitor of sphingosine kinase 2 and dihydroceramide desaturase, in refractory or relapsed multiple myeloma (MM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Opaganib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2016to May 2019
- Phase
- Phase 1/2
- 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
- Patient must have a diagnosis of symptomatic multiple myeloma, relapsed or refractory after previous treatment with a proteasome inhibitor (bortezomib or carfilzomib) and an immunomodulatory agent (thalidomide, lenalidomide or pomalidomide).
- Have measurable disease as defined by at least one of the following:
- Serum monoclonal (M) protein ≥1.0 g/dl by protein electrophoresis
- >200 mg of M protein in the urine on 24 hour electrophoresis
- Serum immunoglobulin free light chain ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
- Monoclonal bone marrow plasmacytosis ≥30%
Show all 23Show fewer
- Voluntary signed and dated institutional review board (IRB) approved informed consent form in accordance with regulatory and institutional guidelines.
- Time interval from last systemic chemotherapy (not including low dose dexamethasone) more than 2 weeks prior to initiation of ABC294640. Patients receiving high dose dexamethasone defined as 40mg dexamethasone a day for 4 days will need 2 weeks washout prior to initiation of ABC294640
- 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal (CTCAE Grade 1 baseline)
- AST (aminotransferase) (SGOT), ALT (alanine aminotransferase) (SGPT) ≤ 5 x ULN (CTCAE Grade 2 baseline)
- Serum creatinine ≤1.5 XULN (1.5 times the upper limit of normal) (CTCAE Grade 1 baseline)
- Acceptable hematologic status (with or without transfusion support):
- Absolute neutrophil count ≥1000 cells/mm3,
- Platelet count ≥50,000 (plt/mm3),
- Hemoglobin ≥9 g/dL.
- Urinalysis: No clinically significant abnormalities.
- PT (partial thromboplastin) and PTT (partial thromboplastin time) ≤ 1.5 X ULN after correction of nutritional deficiencies that may contribute to prolonged PT/PTT.
- As determined by the treating investigator, the patient must have well-controlled blood pressure, defined as systolic blood pressure <150mmHg (Millimeter of Mercury)and/or diastolic blood pressure <100 mmHg for the majority of measurements.
- A negative pregnancy test (if female of child bearing potential).
- For men and women of child-producing potential, willingness to use effective contraceptive methods during the study.
Who cannot join
- Pregnant or nursing women.
- Patients who are currently participating in any other clinical trial of an investigational product.
- Major surgery within 30 days prior to start of treatment
- Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to start of treatment
- Known human immunodeficiency virus infection
- Active hepatitis B or C infection with abnormal liver functions (i.e., LFTs (liver function test) > 2 x upper normal limits)
Show all 11Show fewer
- Unstable angina or myocardial infarction within 4 months prior to start of treatment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to start of treatment
- Nonhematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder
- Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to initiation of ABC294640
- Any other clinically significant medical or psychiatric disease or condition, or social situation that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: A Phase Ib/II Safety and Efficacy Study of ABC294640 in Patients With Refractory or Relapsed Multiple Myeloma Who Have Previously Been Treated With Proteasome Inhibitors and Immunomodulatory Drugs
This is a Phase Ib/II safety and efficacy trial of single agent ABC294640, an inhibitor of sphingosine kinase 2 and dihydroceramide desaturase, in refractory or relapsed multiple myeloma (MM). Cohorts of patients with refractory or relapsed MM who have previously been treated with proteasome inhibitors and immunomodulatory agents will receive increasing doses of oral ABC294640. The starting dosage for ABC294640 will be 250 mg bis in die (BID) which is known to be safely tolerated as a single agent, and the ABC294640 dose will be escalated to two additional dose cohorts of 500 and 750 mg BID using Bayesian model average continual reassessment method (BMA-CRM) for dose finding. It is expected that 18 patients will be used to determine the maximum tolerated dose (MTD) for ABC294640 in refractory or relapsed MM. Up to 56 additional patients will be treated on the phase II portion of the study at the MTD or maximum dose used in phase I, with interim stopping rules for futility.
Pharmacokinetic (PK) and pharmacodynamic (PD) assessments of ABC294640 will be conducted on Day 1 of Cycle 1. Bone marrow biopsy will be obtained prior to the initiation of ABC294640, at the end of cycle #3 and at the end of cycle #6. In addition to serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP) and serum free light chain measurement, correlative studies will be performed to measure sphingosine kinase 2 (SK2) activity, sphingosine metabolites, and additional biomarkers in CD138+ myeloma cells.
Read the detailed description
Objectives for Phase 1b:
Primary Objectives • To assess safety and determine the maximum tolerated dose (MTD) of single agent ABC294640 in patients with refractory or relapsed multiple myeloma (MM) who have been previously treated with proteasome inhibitors and immunomodulatory agents.
Secondary Objectives
- To assess the antitumor activity of single agent ABC294640 in patients with refractory or relapsed MM after 3 cycles of treatment.
- To determine the pharmacokinetics of ABC294640 following administration of the drug.
- To describe the effects of ABC294640 on plasma levels of sphingosine 1-phosphate and IL-6 (interleukin - 6) in patients with refractory or relapsed MM.
- To assess pharmacodynamic markers (SK2 mRNA (messenger ribonucleic acid) level or activity, sphingolipid metabolites, c-Myc, Mcl-1 and pS6) in bone marrow CD138+ myeloma cells.
Objectives for Phase 2:
Primary Objectives
- Assess overall treatment response rate and overall survival in patients with relapsed or refractory MM treated with single-agent ABC294640.
Secondary Objectives
- To assess the treatment response of ABC294640 in patients with refractory or relapsed MM after 3 cycles of treatment.
- To determine if pharmacodynamic markers (SK2 mRNA or activity, sphingolipid metabolites, c-Myc, Mcl-1 and pS6) in bone marrow CD138+ myeloma cells predict tumor response to the treatment with ABC294640.
The projected ABC294640 doses for the escalation phase are: 250, 500, and 750 mg BID orally continuously as determined in the single agent trial for ABC294640. The dose will be given under fasting conditions (at least 1 hour before or 2 hours after eating). Each cycle of treatment is 28 days.
Patients will be monitored for safety and pharmacodynamics effects weekly in Cycle 1, biweekly for Cycles 2-4, and monthly for subsequent cycles.
Myeloma treatment response will be assessed as follows:
- Serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP) and serum free light chains before each cycle.
- Skeletal survey at screening, then every year or at the end of study if the study ends before the anniversary.
- Bone marrow biopsy and aspirates at the last day of cycle #3 and cycle #6 (± 7 days).
For the phase II portion of the study, patients will be treated with single agent ABC294640 at the MTD determined from the phase Ib study (or highest dose used, if MTD is not reached) until disease progression or intolerable toxicity occurs.
- Conditions
- Multiple Myeloma
- Being tested
- Opaganib
- Keywords
- sphingosine kinase 2 inhibitor, sphingosine kinase 2, SK2 inhibitor, SK2
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpaganibDrug
Also called ABC294640
Opaganib, [3-(4-chlorophenyl)-adamantane-1-carboxylic acid (N-(Pyridin-4-ylmethyl)pyridine-4-carboxamide) amide, hydrochloride salt] is an orally available inhibitor of the enzyme SK2.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib/II | Experimental | For Phase Ib, the planned ABC294640 (Opaganib) doses for the escalation phase are: 250, 500, and 750 mg BID given continuously. The dose will be given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment.
For phase II study, the patients will be treated with single agent ABC294640 at the MTD determined from the phase IB study (or at the highest dose used, if MTD is not reached) until disease progression or intolerable toxicity occurs in an individual patient. Receives: Drug: Opaganib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Evaluation of three doses of opaganib - 250 mg bid, 500 mg bid and 750 mg bid to determine the maximum tolerated dose (MTD) based upon the dose limiting toxicity (DLT) using a Bayesian model averaging continual reassessment method and is the dose at which the estimated probability of toxicity is closest to the target probability 0.33 among all doses.
Measured: 6 months
Secondary outcomes (3)
To Assess the Antitumor Activity of Single Agent Opaganib in Patients With Refractory or Relapsed Multiple Myeloma After 3 Cycles of Treatment.
Stable disease, partial response, complete response or disease progression.
Measured: After 3 cycles (12 weeks) of treatment
Number of Patients With Dose Limiting Toxicity
For the phase 1b portion of the trial, a dose-limiting toxicity (DLT) was defined as an adverse event at least possibly related to the study medication:
Non-hematologic DLT is defined as any Grade 3 or greater ADR (adverse drug reaction), except symptomatic AEs such as nausea, vomiting, and diarrhea which could be reduced to less than Grade 3 within 72 hours with standard supportive measures (i.e., antiemetics and antidiarrheals).
Hematologic DLT is defined as
- Grade 4 neutropenia or thrombocytopenia that lasts more than 7 days after the last dose of study drug
- or greater than or equal to Grade 3 thrombocytopenia in the presence of greater than or equal to Grade 3 hemorrhage of any organ/site
- or any Grade 5 hematologic toxicity
Measured: 12 months
Maximum Concentration (Cmax) of ABC294640
To determine the Cmax of ABC294640 following administration of the drug.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start13 Dec 2016
- Primary completionMay 2019
- Study completionMay 2019
Why it stopped: Expiration of National Cancer Institute (NCI) funding of the study.
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 (2)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- RedHill Biopharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Apogee Biotechnology Corporation, Duke University, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Yubin Kang, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757326
- Sponsor's protocol ID
- Pro00062304
- Other IDs
- 1R44CA199767-01
- Acronym
- ABC-103
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2016
- Last updated
- 18 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Venkata JK, An N, Stuart R, Costa LJ, Cai H, Coker W, Song JH, Gibbs K, Matson T, Garrett-Mayer E, Wan Z, Ogretmen B, Smith C, Kang Y. Inhibition of sphingosine kinase 2 downregulates the expression of c-Myc and Mcl-1 and induces apoptosis in multiple myeloma. Blood. 2014 Sep 18;124(12):1915-25. doi: 10.1182/blood-2014-03-559385.
PubMed 25122609Kang Y, Sundaramoorthy P, Gasparetto C, Feinberg D, Fan S, Long G, Sellars E, Garrett A, Tuchman SA, Reeves BN, Li Z, Liu B, Ogretmen B, Maines L, Ben-Yair VK, Smith C, Plasse T. Phase I study of opaganib, an oral sphingosine kinase 2-specific inhibitor, in relapsed and/or refractory multiple myeloma. Ann Hematol. 2023 Feb;102(2):369-383. doi: 10.1007/s00277-022-05056-7. Epub 2022 Dec 3.
PubMed 36460794
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Safety and Efficacy Study of ABC294640 in Patients With Refractory or Relapsed Multiple Myeloma Who Have Previously Been Treated With Proteasome Inhibitors and Immunomodulatory Drugs
- ClinicalTrials.gov ID
- NCT02757326
- Acronym / sponsor ID
- ABC-103 / Pro00062304
- Conditions
- Multiple Myeloma
- Keywords
- sphingosine kinase 2 inhibitor, sphingosine kinase 2, SK2 inhibitor, SK2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Expiration of National Cancer Institute (NCI) funding of the study.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- RedHill Biopharma LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Apogee Biotechnology Corporation, Duke University, National Cancer Institute (NCI)
- Study start
- 13 Dec 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Posted 18 Jun 2021
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 Phase Ib/II safety and efficacy trial of single agent ABC294640, an inhibitor of sphingosine kinase 2 and dihydroceramide desaturase, in refractory or relapsed multiple myeloma (MM). Cohorts of patients with refractory or relapsed MM who have previously been treated with proteasome inhibitors and immunomodulatory agents will receive increasing doses of oral ABC294640. The starting dosage for ABC294640 will be 250 mg bis in die (BID) which is known to be safely tolerated as a single agent, and the ABC294640 dose will be escalated to two additional dose cohorts of 500 and 750 mg BID using Bayesian model average continual reassessment method (BMA-CRM) for dose finding. It is expected that 18 patients will be used to determine the maximum tolerated dose (MTD) for ABC294640 in refractory or relapsed MM. Up to 56 additional patients will be treated on the phase II portion of the study at the MTD or maximum dose used in phase I, with interim stopping rules for futility.
Pharmacokinetic (PK) and pharmacodynamic (PD) assessments of ABC294640 will be conducted on Day 1 of Cycle 1. Bone marrow biopsy will be obtained prior to the initiation of ABC294640, at the end of cycle #3 and at the end of cycle #6. In addition to serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP) and serum free light chain measurement, correlative studies will be performed to measure sphingosine kinase 2 (SK2) activity, sphingosine metabolites, and additional biomarkers in CD138+ myeloma cells.
Detailed description
Objectives for Phase 1b:
Primary Objectives • To assess safety and determine the maximum tolerated dose (MTD) of single agent ABC294640 in patients with refractory or relapsed multiple myeloma (MM) who have been previously treated with proteasome inhibitors and immunomodulatory agents.
Secondary Objectives
- To assess the antitumor activity of single agent ABC294640 in patients with refractory or relapsed MM after 3 cycles of treatment.
- To determine the pharmacokinetics of ABC294640 following administration of the drug.
- To describe the effects of ABC294640 on plasma levels of sphingosine 1-phosphate and IL-6 (interleukin - 6) in patients with refractory or relapsed MM.
- To assess pharmacodynamic markers (SK2 mRNA (messenger ribonucleic acid) level or activity, sphingolipid metabolites, c-Myc, Mcl-1 and pS6) in bone marrow CD138+ myeloma cells.
Objectives for Phase 2:
Primary Objectives
- Assess overall treatment response rate and overall survival in patients with relapsed or refractory MM treated with single-agent ABC294640.
Secondary Objectives
- To assess the treatment response of ABC294640 in patients with refractory or relapsed MM after 3 cycles of treatment.
- To determine if pharmacodynamic markers (SK2 mRNA or activity, sphingolipid metabolites, c-Myc, Mcl-1 and pS6) in bone marrow CD138+ myeloma cells predict tumor response to the treatment with ABC294640.
The projected ABC294640 doses for the escalation phase are: 250, 500, and 750 mg BID orally continuously as determined in the single agent trial for ABC294640. The dose will be given under fasting conditions (at least 1 hour before or 2 hours after eating). Each cycle of treatment is 28 days.
Patients will be monitored for safety and pharmacodynamics effects weekly in Cycle 1, biweekly for Cycles 2-4, and monthly for subsequent cycles.
Myeloma treatment response will be assessed as follows:
- Serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP) and serum free light chains before each cycle.
- Skeletal survey at screening, then every year or at the end of study if the study ends before the anniversary.
- Bone marrow biopsy and aspirates at the last day of cycle #3 and cycle #6 (± 7 days).
For the phase II portion of the study, patients will be treated with single agent ABC294640 at the MTD determined from the phase Ib study (or highest dose used, if MTD is not reached) until disease progression or intolerable toxicity occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase Ib/II | Experimental | Drug: OpaganibFor Phase Ib, the planned ABC294640 (Opaganib) doses for the escalation phase are: 250, 500, and 750 mg BID given continuously. The dose will be given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment. For phase II study, the patients will be treated with single agent ABC294640 at the MTD determined from the phase IB study (or at the highest dose used, if MTD is not reached) until disease progression or intolerable toxicity occurs in an individual patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patient must have a diagnosis of symptomatic multiple myeloma, relapsed or refractory after previous treatment with a proteasome inhibitor (bortezomib or carfilzomib) and an immunomodulatory agent (thalidomide, lenalidomide or pomalidomide).
- Have measurable disease as defined by at least one of the following:
- Voluntary signed and dated institutional review board (IRB) approved informed consent form in accordance with regulatory and institutional guidelines.
- Time interval from last systemic chemotherapy (not including low dose dexamethasone) more than 2 weeks prior to initiation of ABC294640. Patients receiving high dose dexamethasone defined as 40mg dexamethasone a day for 4 days will need 2 weeks washout prior to initiation of ABC294640
- 18 years of age or older.
Key exclusion criteria (11 listed)
- Pregnant or nursing women.
- Patients who are currently participating in any other clinical trial of an investigational product.
- Major surgery within 30 days prior to start of treatment
- Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to start of treatment
- Known human immunodeficiency virus infection
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 |
|---|---|---|
| OpaganibAlso: ABC294640Opaganib, [3-(4-chlorophenyl)-adamantane-1-carboxylic acid (N-(Pyridin-4-ylmethyl)pyridine-4-carboxamide) amide, hydrochloride salt] is an orally available inhibitor of the enzyme SK2. | Drug | Phase Ib/II |
Primary outcome
Maximum Tolerated Dose
Time frame: 6 months
Evaluation of three doses of opaganib - 250 mg bid, 500 mg bid and 750 mg bid to determine the maximum tolerated dose (MTD) based upon the dose limiting toxicity (DLT) using a Bayesian model averaging continual reassessment method and is the dose at which the estimated probability of toxicity is closest to the target probability 0.33 among all doses.
3 secondary outcomes
To Assess the Antitumor Activity of Single Agent Opaganib in Patients With Refractory or Relapsed Multiple Myeloma After 3 Cycles of Treatment.
Time frame: After 3 cycles (12 weeks) of treatment
Number of Patients With Dose Limiting Toxicity
Time frame: 12 months
Maximum Concentration (Cmax) of ABC294640
Time frame: 8 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25122609Venkata JK, An N, Stuart R, Costa LJ, Cai H, Coker W, Song JH, Gibbs K, Matson T, Garrett-Mayer E, Wan Z, Ogretmen B, Smith C, Kang Y. Inhibition of sphingosine kinase 2 downregulates the expression of c-Myc and Mcl-1 and induces apoptosis in multiple myeloma. Blood. 2014 Sep 18;124(12):1915-25. doi: 10.1182/blood-2014-03-559385.
- Derived from this study: PubMed 36460794Kang Y, Sundaramoorthy P, Gasparetto C, Feinberg D, Fan S, Long G, Sellars E, Garrett A, Tuchman SA, Reeves BN, Li Z, Liu B, Ogretmen B, Maines L, Ben-Yair VK, Smith C, Plasse T. Phase I study of opaganib, an oral sphingosine kinase 2-specific inhibitor, in relapsed and/or refractory multiple myeloma. Ann Hematol. 2023 Feb;102(2):369-383. doi: 10.1007/s00277-022-05056-7. Epub 2022 Dec 3.
- 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.
Yubin Kang, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Opaganib in people with Multiple Myeloma, run by RedHill Biopharma Limited 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 23 inclusion and 11 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 18 Jun 2021. 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 combined 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.
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 18 Jun 2021). 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?
Maximum Tolerated Dose (time frame: 6 months). 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 NCT02757326, which also lists 2 linked publications.
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 18 Jun 2021.