Chronic B-cell Lymphocytic LeukemiaPhase 1NCT02556346
Pharmacokinetics (PK), Pharmacodynamics (PD), Safety, Tolerability of Multiple Dose Regimens of MT-3724 for the Treatment of Patients With Relapsed Chronic B-cell Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 1 study testing MT-3724 in people with Chronic B-cell Lymphocytic Leukemia and Small Lymphocytic Leukemia, run by Molecular Templates, Inc..
Trial summary
This Phase I, multiple ascending dose study will seek to enroll subjects with relapsed/refractory Chronic B-cell Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) with confirmed and measurable disease who have received standard treatment with at least one anti-CD20 antibody (e.g.; rituximab, ofatumumab)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic B-cell Lymphocytic Leukemia, Small Lymphocytic Leukemia
- What is being tested?
- MT-3724
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Dec 2016
- 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
- Men or women, age 18 years or older
- Life expectancy > 3 months
- Flow cytometric confirmation of CLL is required at screening. Previous confirmation of CLL/SLL including confirmed immunohistological diagnosis with a characteristic CD5+/CD20+ B-cell immunophenotype according to WHO criteria
- For CLL: a. An absolute peripheral blood monoclonal CD20+/CD5+ B-lymphocyte count > 5000/μL for the duration of at least 3 months
- For SLL: An absolute peripheral blood monoclonal CD20+/CD5+ B-lymphocyte count < 5000/μL AND Presence of lymphadenopathy and/or splenomegaly, with histopathological evaluation of a lymph node biopsy consistent with CLL/SLL.
- Staging CLL: Rai Stage III or IV disease, or stage 0-II disease that meets NCIWG criteria for active disease requiring therapy; SLL: Intermediate or high risk by Ann Arbor Staging with Cotswald Modifications that meets criteria for active disease requiring therapy.
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- Relapsed/ Refractory CLL/SLL that has progressed despite treatment with all approved therapies known to provide clinical benefit for their disease and for which the potential subject is eligible or the potential subject must have refused any other available approved treatment options prior to consideration for enrollment.
- Potential subjects must have received at least one anti-CD20 antibody containing regimen in the past that resulted in initial measurable response (partial or complete remission), followed by relapse/recurrence.
- Potential subjects for which high-dose chemotherapy and autologous stem cell transplantation (HD-ASCT) is considered a standard curative therapy are eligible for this study if the potential subject's disease has relapsed after HD-ASCT, or the potential subject is not eligible for HD-ASCT or the potential subject has refused HD-ASCT.
- Potential subjects who have had HD-ASCT must be at least 26 weeks beyond transplant.
- All potential subjects are required to have measurable disease following previous therapy for CLL/SLL. Measurable disease, as determined by NCI-WG criteria, following standard first-line or salvage therapy; this includes potential subjects with progressive disease (PDs), stable disease (SDs), or partial remission (PR) and/or Residual disease as determined by measurable disease (i.e., PDs, SDs, or PR) or by MRD positivity, determined by flow cytometry of bone marrow and/or peripheral blood (see Laboratory Manual) in potential subjects with Complete Response (CR) or CR with incomplete bone marrow recovery (CRi) (previously termed "nodular partial remission" [(nPR])
- Eastern Cooperative Oncology Group (ECOG) performance status of < 2.
- Patients must be at least 28 days past their last course of leukemia or lymphoma treatment and have recovered from side effects of such therapy completely or with only minor residual symptoms including any significant laboratory. Patients with pre-existing severe or life threatening side effects/conditions from prior therapy or due to other diseases may not be enrolled
- Female patients of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to initiating dosing. Male and female subjects with reproductive potential must agree to use acceptable contraceptive methods while on study therapy and for 12 week following their last dose of study medication.
Who cannot join
- Ongoing use of any approved or investigational anti-neoplastic therapies with the exceptions of ongoing hormonal therapy for breast cancer (without evidence of active disease) or prostate cancer (stable on hormonal therapy).
- History of an absolute anti-CD20 monoclonal antibody (MAb) refractory CLL/SLL, defined as a failure to have ever achieved a PR, CR with persistent lymphocytic nodules in the marrow ("nPR"), or CR for at least 6 months in response to at least one anti-CD20 MAb-containing regimen amongst all past CLL/SLL treatments.
- Potential subjects cannot have experienced a significant (CTCAE Grade 3 or 4 with or without neutropenia) infection within 2 weeks of the first dose of MT-3724.
- Patients who cannot comply with protocol requirements including clinic visits for intravenous infusions and birth control measures may not be enrolled.
- Female patients who are pregnant or are breast feeding.
- Patients are not eligible if they are using any other approved or investigational anti-neoplastic therapies or any other investigational therapies for any other reason.
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- Patients may not be receiving systemic corticosteroid therapy at a prednisone dose > 20 mg/day (or steroid equivalent) within 2 weeks of starting study.
- Patients with uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina within 6 months prior to start of study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, or cardiac amyloidosis may not be enrolled.
- Patients with a known history of drug abuse or any chronic neurologic, psychiatric, endocrine, metabolic, immunologic, hepatic or renal disease (including a history of hemolytic uremic syndrome) that in the opinion of the Investigator would adversely affect study participation.
- Patients with known active Hepatitis C, HIV or a present history of Hepatitis B
- Patients must not have received any vaccines for 28 days prior to administration of their first dose of MT-3724 and should not receive any vaccine during the study or within 28 days after their last dose of MT-3724.
- Patients with a suspected allergy or sensitivity to any component of MT-3724 drug preparation based upon known allergies to compounds of a similar class who have had an anaphylactic or other severe infusion reaction to human immunoglobulin or monoclonal antibody administration are not eligible.
- Potential subjects who have undergone allogeneic hematopoietic stem cell transplant or any solid organ transplant.
- Autologous hematopoietic stem cell transplant within 26 weeks prior to study entry; any history of allogeneic hematopoietic stem cell transplant.
About this study
Official title: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 for the Treatment of Patients With Relapsed Chronic B-cell Lymphocytic Leukemia or Small Lymphocytic Lymphoma
This Phase I, multiple ascending dose study will seek to enroll subjects with relapsed/refractory Chronic B-cell Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) with confirmed and measurable disease who have received standard treatment with at least one anti-CD20 antibody (e.g.; rituximab, ofatumumab) containing front-line regimen that resulted in initial response, followed by relapse/recurrence and who are not eligible for any further approved biologic therapy, chemotherapy and/or autologous stem transplantation and/or refuse alternative approved therapies and/or are unlikely to achieve clinical benefit from any therapy of higher priority by Investigator assessment.
Read the detailed description
This study is intended to provide investigators and sponsor with the following information regarding the investigational new drug MT-3724 in patients with relapsed/refractory Chronic B-cell Lymphocytic Leukemia or Small Lymphocytic Lymphoma:
The maximum dose of a single course of MT-3724 given as intravenous (IV) infusions on Days 1, 3, 5, 8, 10 and 12 at which there are negligible side effects and/or at which maximum serum levels and/or at which maximum effect on blood lymphocytes are observed. Four dose levels will be investigated.
The changes in MT-3724 serum levels and blood lymphocytes over time following IV doses at different points in the study.
The changes and kinds of clinical and laboratory effects and side effects that may occur over repeated courses of MT-3724 The changes in each subject's immune status and their CLL or SLL following one or more cycles of 6 infusions.
- Being tested
- MT-3724
- Keywords
- CD20, immunotoxin, CLL, SLL, leukemia, lymphocytic lymphoma, lymphocytic leukemia, MT-3724, relapsed, refractory, immunotherapy, cancer, antibodies, safety, pharmacokinetics
- Medical subject headings
- Leukemia, B-Cell, Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Lymphoid, Recurrence, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-3724Drug
Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 4 week initial cycle and then 3 week repeat cycles for up to 5 total cycles.
MT-3724Drug
Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 4 week initial cycle and then 3 week repeat cycles for up to 5 total cycles.
MT-3724Drug
Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 4 week initial cycle and then 3 week repeat cycles for up to 5 total cycles.
MT-3724Drug
Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 4 week initial cycle and then 3 week repeat cycles for up to 5 total cycles.
MT-3724Drug
Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 4 week initial cycle and then 3 week repeat cycles for up to 5 total cycles.
| Study group | Role | What they receive |
|---|---|---|
| MT-3724 Phase 1 5 mcg/kg/dose | Experimental | MT-3724 5 mcg/kg/dose IV for 6 doses over 12 days (M-W-F X 2 weeks), followed by dose escalations (Phase 1) until recommended phase 2 dose of MT-3724 is determined Receives: Drug: MT-3724 |
| MT-3724 Phase 1 10 mcg/kg/dose | Experimental | MT-3724 10 mcg/kg/dose IV for 6 doses over 12 days (M-W-F X 2 weeks), followed by dose escalations (Phase 1) until recommended phase 2 dose of MT-3724 is determined Receives: Drug: MT-3724 |
| MT-3724 Phase 1 20 mcg/kg/dose | Experimental | MT-3724 20 mcg/kg/dose IV for 6 doses over 12 days (M-W-F X 2 weeks), followed by dose escalations (Phase 1) until recommended phase 2 dose of MT-3724 is determined Receives: Drug: MT-3724 |
| MT-3724 Phase 1 50 mcg/kg/dose | Experimental | MT-3724 50 mcg/kg/dose IV for 6 doses over 12 days (M-W-F X 2 weeks), followed by dose escalations (Phase 1) until recommended phase 2 dose of MT-3724 is determined Receives: Drug: MT-3724 |
| MT-3724 Phase 1b | Experimental | MT-3724 IV for 6 doses over 12 days for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724 (subject will continue with dose that was tolerated in the Phase 1 portion of the study) Receives: Drug: MT-3724 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability as measured by number of subjects with dose limiting toxicities
Evaluation of tolerability of MT-3724 measured by number of subjects with dose limiting toxicities (DLTs)
Measured: 28 days
Safety as measured by number of subjects with Adverse Events using CTCAE
Safety measured by number of subjects with Adverse Events using CTCAE Version 4.03
Measured: 28 days and then every 6 months for up to 24 months following first dose if subject does not continue into Phase Ib
Tolerability as measured by adverse events using CTCAE and clinical laboratory parameters
Evaluation of tolerability of MT-3724 given for up to 4 additional cycles measured by number, nature and severity of Adverse Events using CTCAE Version 4.03
Measured: 2-3 weeks following last dose and then every 6 months for up to 24 months following first dose
Secondary outcomes (5)
PK as measured by concentrations of free MT-3724 (Cmax, Cinf)
Evaluation of the pharmacokinetic profile of MT-3724
Measured: Days 1, 5, 8, 12, 23, and 28
PK as measured by area under the curve of free MT-3724 (AUC)
Evaluation of the pharmacokinetic profile of MT-3724
Measured: Days 1, 5, 8, 12, 23, and 28
PK as measured by time to maximum concentration of free MT-3724 ( tmax)
Evaluation of the pharmacokinetic profile of MT-3724
Measured: Days 1, 5, 8, 12, 23, and 28
PD as measured by immunogenicity (anti-drug antibodies)
Evaluation of the pharmacodynamic profile of MT-3724
Measured: During Screening, Days 23-25, Day 1 of cycle 2, and at final end of study visit
Tumor Response as measured by PET or CT scan
Evaluation of tumor response using International Working Group Response Criteria
Measured: During Screening, Days 43 & 86
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: The patient population (CLL \& SLL) was included in another ongoing study involving NHL patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic B-cell Lymphocytic LeukemiaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molecular Templates, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Valacer, MD, Study director, Molecular Templates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556346
- Sponsor's protocol ID
- MT-3724_CLL_SLL_001
- Status last verified
- Feb 2016
- First submitted
- 16 Sep 2015
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 for the Treatment of Patients With Relapsed Chronic B-cell Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- ClinicalTrials.gov ID
- NCT02556346
- Acronym / sponsor ID
- MT-3724_CLL_SLL_001
- Keywords
- CD20, immunotoxin, CLL, SLL, leukemia, lymphocytic lymphoma, lymphocytic leukemia, MT-3724
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The patient population (CLL \& SLL) was included in another ongoing study involving NHL patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Molecular Templates, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 22 Sep 2015 (estimated)
- 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 Phase I, multiple ascending dose study will seek to enroll subjects with relapsed/refractory Chronic B-cell Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) with confirmed and measurable disease who have received standard treatment with at least one anti-CD20 antibody (e.g.; rituximab, ofatumumab) containing front-line regimen that resulted in initial response, followed by relapse/recurrence and who are not eligible for any further approved biologic therapy, chemotherapy and/or autologous stem transplantation and/or refuse alternative approved therapies and/or are unlikely to achieve clinical benefit from any therapy of higher priority by Investigator assessment.
Detailed description
This study is intended to provide investigators and sponsor with the following information regarding the investigational new drug MT-3724 in patients with relapsed/refractory Chronic B-cell Lymphocytic Leukemia or Small Lymphocytic Lymphoma:
The maximum dose of a single course of MT-3724 given as intravenous (IV) infusions on Days 1, 3, 5, 8, 10 and 12 at which there are negligible side effects and/or at which maximum serum levels and/or at which maximum effect on blood lymphocytes are observed. Four dose levels will be investigated.
The changes in MT-3724 serum levels and blood lymphocytes over time following IV doses at different points in the study.
The changes and kinds of clinical and laboratory effects and side effects that may occur over repeated courses of MT-3724 The changes in each subject's immune status and their CLL or SLL following one or more cycles of 6 infusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MT-3724 Phase 1 5 mcg/kg/dose | Experimental | Drug: MT-3724MT-3724 5 mcg/kg/dose IV for 6 doses over 12 days (M-W-F X 2 weeks), followed by dose escalations (Phase 1) until recommended phase 2 dose of MT-3724 is determined |
| MT-3724 Phase 1 10 mcg/kg/dose | Experimental | Drug: MT-3724MT-3724 10 mcg/kg/dose IV for 6 doses over 12 days (M-W-F X 2 weeks), followed by dose escalations (Phase 1) until recommended phase 2 dose of MT-3724 is determined |
| MT-3724 Phase 1 20 mcg/kg/dose | Experimental | Drug: MT-3724MT-3724 20 mcg/kg/dose IV for 6 doses over 12 days (M-W-F X 2 weeks), followed by dose escalations (Phase 1) until recommended phase 2 dose of MT-3724 is determined |
| MT-3724 Phase 1 50 mcg/kg/dose | Experimental | Drug: MT-3724MT-3724 50 mcg/kg/dose IV for 6 doses over 12 days (M-W-F X 2 weeks), followed by dose escalations (Phase 1) until recommended phase 2 dose of MT-3724 is determined |
| MT-3724 Phase 1b | Experimental | Drug: MT-3724MT-3724 IV for 6 doses over 12 days for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724 (subject will continue with dose that was tolerated in the Phase 1 portion of the study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Men or women, age 18 years or older
- Life expectancy > 3 months
- Flow cytometric confirmation of CLL is required at screening. Previous confirmation of CLL/SLL including confirmed immunohistological diagnosis with a characteristic CD5+/CD20+ B-cell immunophenotype according to WHO criteria
- For CLL: a. An absolute peripheral blood monoclonal CD20+/CD5+ B-lymphocyte count > 5000/μL for the duration of at least 3 months
- For SLL: An absolute peripheral blood monoclonal CD20+/CD5+ B-lymphocyte count < 5000/μL AND Presence of lymphadenopathy and/or splenomegaly, with histopathological evaluation of a lymph node biopsy consistent with CLL/SLL.
Key exclusion criteria (14 listed)
- Ongoing use of any approved or investigational anti-neoplastic therapies with the exceptions of ongoing hormonal therapy for breast cancer (without evidence of active disease) or prostate cancer (stable on hormonal therapy).
- History of an absolute anti-CD20 monoclonal antibody (MAb) refractory CLL/SLL, defined as a failure to have ever achieved a PR, CR with persistent lymphocytic nodules in the marrow ("nPR"), or CR for at least 6 months in response to at least one anti-CD20 MAb-containing regimen amongst all past CLL/SLL treatments.
- Potential subjects cannot have experienced a significant (CTCAE Grade 3 or 4 with or without neutropenia) infection within 2 weeks of the first dose of MT-3724.
- Patients who cannot comply with protocol requirements including clinic visits for intravenous infusions and birth control measures may not be enrolled.
- Female patients who are pregnant or are breast feeding.
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 |
|---|---|---|
| MT-3724Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 4 week initial cycle and then 3 week repeat cycles for up to 5 total cycles. | Drug | MT-3724 Phase 1 5 mcg/kg/dose |
| MT-3724Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 4 week initial cycle and then 3 week repeat cycles for up to 5 total cycles. | Drug | MT-3724 Phase 1 10 mcg/kg/dose |
| MT-3724Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 4 week initial cycle and then 3 week repeat cycles for up to 5 total cycles. | Drug | MT-3724 Phase 1 20 mcg/kg/dose |
| MT-3724Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 4 week initial cycle and then 3 week repeat cycles for up to 5 total cycles. | Drug | MT-3724 Phase 1 50 mcg/kg/dose |
| MT-3724Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 4 week initial cycle and then 3 week repeat cycles for up to 5 total cycles. | Drug | MT-3724 Phase 1b |
Primary outcome
Tolerability as measured by number of subjects with dose limiting toxicities
Time frame: 28 days
Evaluation of tolerability of MT-3724 measured by number of subjects with dose limiting toxicities (DLTs)
Safety as measured by number of subjects with Adverse Events using CTCAE
Time frame: 28 days and then every 6 months for up to 24 months following first dose if subject does not continue into Phase Ib
Safety measured by number of subjects with Adverse Events using CTCAE Version 4.03
Tolerability as measured by adverse events using CTCAE and clinical laboratory parameters
Time frame: 2-3 weeks following last dose and then every 6 months for up to 24 months following first dose
Evaluation of tolerability of MT-3724 given for up to 4 additional cycles measured by number, nature and severity of Adverse Events using CTCAE Version 4.03
5 secondary outcomes
PK as measured by concentrations of free MT-3724 (Cmax, Cinf)
Time frame: Days 1, 5, 8, 12, 23, and 28
PK as measured by area under the curve of free MT-3724 (AUC)
Time frame: Days 1, 5, 8, 12, 23, and 28
PK as measured by time to maximum concentration of free MT-3724 ( tmax)
Time frame: Days 1, 5, 8, 12, 23, and 28
PD as measured by immunogenicity (anti-drug antibodies)
Time frame: During Screening, Days 23-25, Day 1 of cycle 2, and at final end of study visit
Tumor Response as measured by PET or CT scan
Time frame: During Screening, Days 43 & 86
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
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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.
David Valacer, MD study director
Molecular Templates
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT-3724 in people with Chronic B-cell Lymphocytic Leukemia and Small Lymphocytic Leukemia, run by Molecular Templates, Inc..
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 14 inclusion and 14 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: withdrawn, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Tolerability as measured by number of subjects with dose limiting toxicities (time frame: 28 days). The study lists 3 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 2 Mar 2016.