Chronic Myeloid LeukemiaPhase 1NCT02011945
A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia
A Phase 1 study testing Dasatinib and Nivolumab in people with Chronic Myeloid Leukemia, run by Bristol-Myers Squibb at 21 sites in 7 countries.
Trial summary
The purpose of this study is to find a dose of Nivolumab that can be safely added to Dasatinib in patients with Chronic Myeloid Leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- Dasatinib and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 21 sitesin 7 countries
- Study dates
- 7 Feb 2014to 26 Dec 2018
- Phase
- Phase 1
- 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
- Confirmed diagnosis of Chronic Myeloid Leukemia in Chronic Phase or Accelerated Phase :
- With historically documented Ph+ cells
- ≥2 prior Tyrosine Kinase Inhibitors (TKI) therapies for CML
- Currently progressing, resistance to or with a suboptimal response to their most recent therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score 0 - 1
Who cannot join
- Blast phase CML
- Known Abl-kinase mutation resistant to Dasatinib (e.g. T315I or T315A)
Trial locations and contacts
21 sites in 7 countries.
21 sites in 7 countries
United States5 sites
Winship Cancer Institute
Atlanta, Georgia, 30322
Dana Farber Cancer Institute.
Boston, Massachusetts, 02215
Ut Southwestern Medical Center At Dallas
Dallas, Texas, 75390
The University Of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Germany4 sites
Campus Virchow Klinikum Der Charite
Berlin, 13353
Universitaetsklinikum Bonn
Bonn, 53127
Universitaetsklinikum Carl Gustav Carus
Dresden, 01307
Universitaetsklinik Frankfurt
Frankfurt am Main, 60590
Australia3 sites
Local Institution
Adelaide, South Australia, 5000
Local Institution
Parkville, Victoria, 3050
Local Institution
St Leonards, New South Wales, 2065
Canada3 sites
QEII Health Sciences Centre-VG Site
Halifax, Nova Scotia, B3H 2Y9
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Italy3 sites
Local Institution
Naples, 80131
Local Institution
Orbassano, 10043
Local Institution
Roma, 00161
About this study
Official title: A Phase 1B Dose Escalation Study to Investigate the Safety, Tolerability and Preliminary Efficacy for the Combination Dasatinib (BMS-354825) Plus Nivolumab (BMS-936558) in Patients Chronic Myeloid Leukemia (CML)
The purpose of this study is to find a dose of Nivolumab that can be safely added to Dasatinib in patients with Chronic Myeloid Leukemia.
- Conditions
- Chronic Myeloid Leukemia
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dasatinib Only | Experimental | dasatinib 100 mg QD(CP) or 140 mg QD (AP) Receives: Drug: Dasatinib |
| Dose Level 1 | Experimental | Nivolumab 1 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP) Receives: Drug: Dasatinib; Drug: Nivolumab |
| Dose Level 2 | Experimental | Nivolumab 3 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP) Receives: Drug: Dasatinib; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLT)
DLT will be determined based on the incidence and intensity of drug related adverse events (AEs). The following drug-related AEs (whether related to one or both agents) occurring during the first 6 weeks of combined treatment with both dasatinib plus nivolumab (ie, Weeks 3 to 8, inclusive) would be considered DLTs:
- Grade 4 hematologic AE lasting > 7 days despite appropriate medical intervention, except as noted below;
- Grade 3 or Grade 4 nonhematologic AE irrespective of duration;
- Grade 2 nonhematologic AE lasting > 7 days despite appropriate medical intervention (exception: asymptomatic laboratory values of Grade 2 which do not require medical intervention);
- Any toxicity managed by discontinuation of nivolumab;
- Grade ≥ 2 AE not controlled by medical intervention and requiring dasatinib treatment interruption for > 28 consecutive days;
- Grade ≥ 2 AE not controlled by medical intervention and requiring missing 2 consecutive doses of nivolumab.
Measured: Week 3 to week 6
Incidence of Adverse Events (AEs)
Any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Measured: Initiation of study drug to discontinuation of nivolumab stop date + 100 days or discontinuation of dasatinib + 30 days
Incidence of Serious Adverse Events (SAEs)
Any untoward medical occurrence that at any dose: results in death, is life threatening, requires in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a important medical event.Requires inpatient hospitalization or causes prolongation of existing hospitalization, results.
Measured: Initiation of study drug to within 100 days of discontinuation of nivolumab dosing and 30 days of dasatinib dosing
Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology
The number of participants with a shift in laboratory test results from baseline to Grade 3-4 in hematology
Measured: Up to 40 Months
Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests
The number of participants with an abnormal Liver function test.
Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN)
Measured: Up to 40 Months
Incidence of Laboratory Abnormalities in Specific Thyroid Tests
Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN)
Measured: Up to 40 Months
Secondary outcomes (18)
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS).
Measured: upto 36 Months
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS).
Measured: upto 36 Months
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS).
Measured: upto 36 Months
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS).
Measured: upto 36 Months
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS).
Measured: upto 36 Months
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS).
Measured: upto 36 Months
Time to Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants
measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Measured: Up to 36 Months
Time to Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants
measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Measured: Up to 36 Months
Time to Major Molecular Response (MMR) - CML-AP Participants
measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Measured: Up to 36 Months
Duration of Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants
will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Measured: Up to 36 Months
Duration of Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants
will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Measured: Up to 36 Months
Duration of Major Molecular Response (MMR) - CML-AP Participants
will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Measured: Up to 36 Months
Time to Molecular Response 4.5(MR4.5) - CML-CP No Prior Dasatinib Participants
measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Measured: Up to 36 Months
Time to Molecular Response 4.5(MR4.5) - CML-CP Prior Dasatinib Participants
measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Measured: Up to 36 Months
Time to Molecular Response 4.5(MR4.5) - CML-AP Participants
measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Measured: Up to 36 Months
Duration of Molecular Response 4.5 (MR4.5) - CML-CP No Prior Dasatinib Participants
will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Measured: Up to 36 Months
Duration of Molecular Response 4.5 (MR4.5) - CML-CP Prior Dasatinib Participants
will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Measured: Up to 36 Months
Duration of Molecular Response 4.5 (MR4.5) - CML-AP Participants
will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Measured: Up to 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study start7 Feb 2014
- Primary completion26 Dec 2018
- Study completion26 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011945
- Sponsor's protocol ID
- CA180-373
- Other IDs
- 2013-002156-33
- Status last verified
- Feb 2020
- First submitted
- 21 Nov 2013
- Last updated
- 18 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B Dose Escalation Study to Investigate the Safety, Tolerability and Preliminary Efficacy for the Combination Dasatinib (BMS-354825) Plus Nivolumab (BMS-936558) in Patients Chronic Myeloid Leukemia (CML)
- ClinicalTrials.gov ID
- NCT02011945
- Acronym / sponsor ID
- CA180-373
- Conditions
- Chronic Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2014 (actual)
- Primary completion
- 26 Dec 2018 (actual)
- Study completion
- 26 Dec 2018 (actual)
- First posted
- 16 Dec 2013 (estimated)
- Results
- Posted 17 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find a dose of Nivolumab that can be safely added to Dasatinib in patients with Chronic Myeloid Leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dasatinib Only | Experimental | Drug: Dasatinibdasatinib 100 mg QD(CP) or 140 mg QD (AP) |
| Dose Level 1 | Experimental | Drug: Dasatinib, Drug: NivolumabNivolumab 1 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP) |
| Dose Level 2 | Experimental | Drug: Dasatinib, Drug: NivolumabNivolumab 3 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of Chronic Myeloid Leukemia in Chronic Phase or Accelerated Phase :
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score 0 - 1
Key exclusion criteria (2 listed)
- Blast phase CML
- Known Abl-kinase mutation resistant to Dasatinib (e.g. T315I or T315A)
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 |
|---|---|---|
| DasatinibAlso: BMS-354825 | Drug | Dose Level 1, Dose Level 2, dasatinib Only |
| NivolumabAlso: BMS-936558 | Drug | Dose Level 1, Dose Level 2 |
Primary outcome
Incidence of Dose Limiting Toxicities (DLT)
Time frame: Week 3 to week 6
DLT will be determined based on the incidence and intensity of drug related adverse events (AEs). The following drug-related AEs (whether related to one or both agents) occurring during the first 6 weeks of combined treatment with both dasatinib plus nivolumab (ie, Weeks 3 to 8, inclusive) would be considered DLTs: * Grade 4 hematologic AE lasting > 7 days despite appropriate medical intervention, except as noted below; * Grade 3 or Grade 4 nonhematologic AE irrespective of duration; * Grade 2 nonhematologic AE lasting > 7 days despite appropriate medical intervention (exception: asymptomatic laboratory values of Grade 2 which do not require medical intervention); * Any toxicity managed by discontinuation of nivolumab; * Grade ≥ 2 AE not controlled by medical intervention and requiring dasatinib treatment interruption for > 28 consecutive days; * Grade ≥ 2 AE not controlled by medical intervention and requiring missing 2 consecutive doses of nivolumab.
Incidence of Adverse Events (AEs)
Time frame: Initiation of study drug to discontinuation of nivolumab stop date + 100 days or discontinuation of dasatinib + 30 days
Any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Incidence of Serious Adverse Events (SAEs)
Time frame: Initiation of study drug to within 100 days of discontinuation of nivolumab dosing and 30 days of dasatinib dosing
Any untoward medical occurrence that at any dose: results in death, is life threatening, requires in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a important medical event.Requires inpatient hospitalization or causes prolongation of existing hospitalization, results.
Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology
Time frame: Up to 40 Months
The number of participants with a shift in laboratory test results from baseline to Grade 3-4 in hematology
Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests
Time frame: Up to 40 Months
The number of participants with an abnormal Liver function test. Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN)
Incidence of Laboratory Abnormalities in Specific Thyroid Tests
Time frame: Up to 40 Months
Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN)
18 secondary outcomes
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants
Time frame: upto 36 Months
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants
Time frame: upto 36 Months
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants
Time frame: upto 36 Months
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants
Time frame: upto 36 Months
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants
Time frame: upto 36 Months
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants
Time frame: upto 36 Months
Time to Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants
Time frame: Up to 36 Months
Time to Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants
Time frame: Up to 36 Months
Time to Major Molecular Response (MMR) - CML-AP Participants
Time frame: Up to 36 Months
Duration of Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants
Time frame: Up to 36 Months
Duration of Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants
Time frame: Up to 36 Months
Duration of Major Molecular Response (MMR) - CML-AP Participants
Time frame: Up to 36 Months
Time to Molecular Response 4.5(MR4.5) - CML-CP No Prior Dasatinib Participants
Time frame: Up to 36 Months
Time to Molecular Response 4.5(MR4.5) - CML-CP Prior Dasatinib Participants
Time frame: Up to 36 Months
Time to Molecular Response 4.5(MR4.5) - CML-AP Participants
Time frame: Up to 36 Months
Duration of Molecular Response 4.5 (MR4.5) - CML-CP No Prior Dasatinib Participants
Time frame: Up to 36 Months
Duration of Molecular Response 4.5 (MR4.5) - CML-CP Prior Dasatinib Participants
Time frame: Up to 36 Months
Duration of Molecular Response 4.5 (MR4.5) - CML-AP Participants
Time frame: Up to 36 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dasatinib and Nivolumab in people with Chronic Myeloid Leukemia, run by Bristol-Myers Squibb at 21 sites in 7 countries.
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 5 inclusion and 2 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Germany, Australia, Canada, Italy and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 17 Jan 2019). 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?
Incidence of Dose Limiting Toxicities (DLT) (time frame: Week 3 to week 6). The study lists 6 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 18 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.