Solid TumorsPhase 1NCT02052492
Safety Study of EF-022 ( Modified Vitamin D Binding Protein Macrophage Activator) in Subjects With Advanced Solid Tumors
A Phase 1 study testing EF-022 (Modified Vitamin D Binding Protein Macrophage Activator) in people with Solid Tumors, run by Efranat Ltd. at 2 sites in Israel.
Trial summary
Activated macrophages, present in excess during natural inflammatory responses, bear the potential to kill and eradicate cancer cells. Macrophage activation has been demonstrated to require the serum-borne vitamin D binding protein (known as Gc protein), as well as B and T lymphocytes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- EF-022 (Modified Vitamin D Binding Protein Macrophage Activator)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesIsrael
- Study dates
- May 2014to May 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with inoperable, recurrent or metastatic tumor, deemed incurable, and who have either failed to respond to standard therapy or for whom no standard therapy is available or refuse to receive standard therapies or in case of SCC, the investigator decides that delay of the standard therapy does not have any risk for the patient.
- Histologically or cytological-confirmed diagnosis of solid tumor on file. For the expanded cohort only the following immunological tumors will be recruited: epithelial ovarian cancer, cervical carcinoma, head \& neck cancer, melanoma, kidney cancer (RCC), gastric cancer, lung cancer (SCLC or NSCLC), sarcoma, bladder cancer or squamous cell carcinoma (SCC) of the skin.
- Measurable disease (i.e., present with at least one measurable lesion per modified RECIST, version 1.1).
- Age: 18-80 years.
- BMI: 18-36.
- ECOG Performance Status 0 or 1.
Show all 18Show fewer
- Estimated life expectancy of at least 4 months.
- Off prior chemotherapy, radiation therapy with curative intent, hormonal therapy, immunotherapy, biological therapies (excluded checkpoint inhibitors and Erbitux), immunosuppressive therapy [e.g., cyclosporine, humera, prograf, etc.] or immunomodulators [e.g., thalidomide, revlimid, etc.] for at least 4 weeks. Hormonal treatment is not allowed ONLY if given as an anti-cancer therapy. In any case the sponsor should be consulted prior to final decision.
- Prior treatment with checkpoint inhibitors (such as anti PD-1, anti PDL-1), and/or Erbitux, and/or palliative irradiation, does not require any wash out period before commencement of study drug treatment.
- Patients who were receiving mitomycin C, nitrosoureas, or carboplatin must be 6 weeks from the last administration of chemotherapy.
- Patients must have adequate organ and marrow function within 7 days of first dosing. Hematology re-test results must keep meeting eligibility criteria on Day 1 of treatment prior to dosing.
- All prior anti-cancer treatment-related toxicities (except alopecia and certain laboratory values) must be ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events at the time of start of treatment. Stable grade 2 peripheral neuropathy secondary to neurotoxicity and/or chronic stable grade 2 radiotherapy related toxicity from prior therapies may be considered on a case by case basis.
- No extensive radiotherapy (e.g., whole-pelvis, greater than 50% of neuroaxis, whole abdomen, whole body) within 12 months prior to start of study treatment.
- No bone marrow transplantation within 3 years prior to start of study treatment.
- Women and man of child bearing potential practicing an acceptable method of birth control during the study and at least 3 months after completion.
- Female patient of childbearing potential has a negative serum pregnancy test within 7 days of first dose.
- Understanding study procedures and willingness to comply for the entire length of the study and to provide written informed consent.
- Patient has previously received maximum 3 regimens of systemic antineoplastic therapies.
Who cannot join
- Current evidence of active and uncontrolled infection.
- Known Cirrhosis.
- Treatment refractory hypertension (blood pressure of systolic> 150 mmHg and/or diastolic > 95 mm Hg) which cannot be controlled by anti-hypertensive therapy;
- A history or evidence of current Class IV congestive heart failure.
- Current left ventricular ejection fraction < 50%
- A history of acute coronary syndromes, coronary angioplasty.
Show all 16Show fewer
- Use of nonsteroidal anti-inflammatory drugs - including Aspirin - and/or any steroids within 7 days prior to start of study treatment (excluding eye drops and ointments). Those medications must be stopped or replaced by another equivalent permitted medication at least 7 days prior to Day 1. Those medications will be allowed within 7 days prior to start of treatment only if required as premedication prior to CT scan for patients who are allergic to the contrast media.
- Patient has a known hypersensitivity to the components of study drug, its analogs, or drugs of similar chemical or biologic composition.
- Patients with known brain metastases.
- Patient has known psychiatric or substance abuse disorders that is uncontrolled and would interfere with cooperation with the requirements of the trial.
- Patient is Human Immunodeficiency virus (HIV)-positive.
- Evidence of active bleeding or bleeding diathesis, including blood or platelet transfusion within 14 days of the commencement of study treatment.
- Patients with known chronic active hepatitis, hepatitis B virus (HBV) or hepatitis C virus (HCV) carriers.
- Any known autoimmune disorders other than hypothyroidism or B12 deficiency.
- Female subjects who are pregnant or nursing.
- Use of alternative medicine (products only) and Herbal drugs with cancer treatment intent is not allowed within 7 days prior to start of study treatment and during the study.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A PHASE I, OPEN LABEL, DOSE-ESCALATION TRIAL EVALUATING THE SAFETY AND TOLERABILITY OF EF-022 (MODIFIED VITAMIN D BINDING PROTEIN MACROPHAGE ACTIVATOR) IN SUBJECTS WITH ADVANCED SOLID MALIGNANCIES
Activated macrophages, present in excess during natural inflammatory responses, bear the potential to kill and eradicate cancer cells. Macrophage activation has been demonstrated to require the serum-borne vitamin D binding protein (known as Gc protein), as well as B and T lymphocytes. However, in various cancer patients the Gc protein is deglycosylated by serum α-N-acetyl galactosaminidase (Nagalase) secreted from cancer cells. This deglycosylated Gc protein, lacking the N-acetylgalactosamine monosaccharide, cannot be converted to its form of Macrophage Activating Factor, leading to immunosuppression rather than Macrophage activation against cancer cells.
Efranat has developed cancer immunotherapy based on Macrophage Activating Factor produced from natural Gc protein extracted from FDA approved healthy human plasma.
Read more
In this phase I study, the treatment is given as Intramuscular, once-weekly injection of EF-022, for two courses, while each course is comprised of 4 injections.
The investigational treatment is expected to enhance immune response, thereby, improve patient's well being, quality of life and disease control.
Primary objectives:
- To determine the safety and tolerability of EF-022 and to define the maximal tolerated dose (MTD) for potential administration.
- To identify the Dose Limiting Toxicity (DLT) of EF-022.
Secondary objectives:
- To determine the 'Recommended Phase 2 Dose' (RP2D) based on MTD data, immunological and pharmacodynamics markers
- To explore preliminary efficacy of EF-022 in advanced solid tumors according to the 'Response Evaluation Criteria in the modified Solid Tumors' (RECIST 1.1) and blood levels of tumor-related markers known to reflect tumor burden.
Exploratory objectives:
- To assess levels of immune-related factors in peripheral blood (determined by FACS analysis), reflecting induced immunological activities, including but not limited to, natural killer (NK), monocytes (M1 and M2) and T cell subpopulations (effector vs regulatory, CD4+ and CD8+ cells), B cells (CD20), myeloid and dendritic cells etc.
- To assess the change in serum levels of protein biomarkers in the blood.
- To immunohistochemically assess and compare tumor derived tissue samples Pre and post treatment. To analyze the infiltration of different population of cells into the tumor bed.
Read the detailed description
Part 1:
Eligible subjects will be assigned, successively in order of accrual, to one of the three cohorts, to receive intramuscular (IM) injections of EF-022, once weekly for two courses of treatment. Each course will consist of 4 injections with one week intervals (total: 8 weeks of treatment).
Dose escalation will only proceed in the absence of dose-limiting toxicity (DLT) during course 1. For this purpose, each cohort will only begin its first course of EF-022 when the cohort preceding it has successfully completed its first 4-week treatment course without any signs of DLT. During this first course, should 1/3 patients experience DLT, dose escalation for the next cohort will not be authorized; the next cohort will receive the same dose as the one preceding it. If 2 patients or more of all patients treated with a given dose develop DLT, dose escalation will be halted and no more patients will be treated at the DLT dose. The value of MTD will be defined as the EF-022 dose below the dose at which DLT was seen for at least 2 subjects. Upon determination of the MTD, an additional cohort will be opened (confirmatory cohort) and treated with two courses of that dose.
Part 2:
During the expanded cohort, 24 Patients will be allocated to receive either 100ng, 500ng or 1000ng weekly treatment as detailed below: The first 18 patients will be assigned to alternating doses of either 100ng or 500ng in a sequential manner (each patient will be assigned to a single dose), with the caveat that given indications should be assigned equally, as much as possible, between these two doses.
Interim analysis will be performed once the 12th patient reaches Day 57 and the CT results as well as PD analysis are available for at least 12 patients, while at least 18 patients have begun study treatment. A decision regarding adding a 1000ng dose cohort vs. continuing with the 100ng and 500ng doses will be based on a discussion of the interim analysis results.
Each patient will receive 2 courses of treatment, i.e. weekly injections for a total period of 8 weeks, followed by a follow-up period of up to 12 months from the start of treatment (Day 1).
Continuation of treatment after the second course will be at the discretion of the investigator. Patients who will continue extended treatment post course 2 will keep the weekly injection dosage mode and continue therapy until disease progression, development of unacceptable toxicities, non-compliance, inter-current illness that prevents treatment continuation, withdrawal of consent, or change in subject condition that renders the subject unacceptable for further treatment.
All study patients who completed at least two courses of treatment will be followed up until 12 months from day 1 of treatment.
- Conditions
- Solid Tumors
- Being tested
- EF-022 (Modified Vitamin D Binding Protein Macrophage Activator)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EF-022 (Modified Vitamin D Binding Protein Macrophage Activator)Drug
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: EF-022 100 ng once weekly | Experimental | Intra-Muscular injections of EF-022 100 ng once weekly for a period of 8 weeks Receives: Drug: EF-022 (Modified Vitamin D Binding Protein Macrophage Activator) |
| Cohort B: EF-022 500 ng once weekly | Experimental | Intra-Muscular injections of EF-022 500 ng once weekly for a period of 8 weeks Receives: Drug: EF-022 (Modified Vitamin D Binding Protein Macrophage Activator) |
| Cohort C: EF-022 1000 ng once weekly | Experimental | Intra-Muscular injections of EF-022 1000 ng once weekly for a period of 8 weeks Receives: Drug: EF-022 (Modified Vitamin D Binding Protein Macrophage Activator) |
| Expanded Cohort | Experimental | the expanded cohort, 24 Patients will be allocated to receive either 100ng, 500ng or 1000ng weekly treatment as detailed below: The first 18 patients will be assigned to alternating doses of either 100ng or 500ng in a sequential manner (each patient will be assigned to a single dose). A decision regarding adding a 1000ng dose cohort vs. continuing with the 100ng and 500ng doses will be based on a discussion of the interim analysis results. Receives: Drug: EF-022 (Modified Vitamin D Binding Protein Macrophage Activator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events that meets the DLT definition
Measured: During first course of treatment (up to 4 weeks)
Percentage of participants with Adverse Events grade 3-4
Measured: During two courses of treatment (up to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Efranat Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052492
- Sponsor's protocol ID
- PR-001
- Status last verified
- Jun 2017
- First submitted
- 30 Jan 2014
- Last updated
- 20 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE I, OPEN LABEL, DOSE-ESCALATION TRIAL EVALUATING THE SAFETY AND TOLERABILITY OF EF-022 (MODIFIED VITAMIN D BINDING PROTEIN MACROPHAGE ACTIVATOR) IN SUBJECTS WITH ADVANCED SOLID MALIGNANCIES
- ClinicalTrials.gov ID
- NCT02052492
- Acronym / sponsor ID
- PR-001
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Efranat Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 3 Feb 2014 (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.
Activated macrophages, present in excess during natural inflammatory responses, bear the potential to kill and eradicate cancer cells. Macrophage activation has been demonstrated to require the serum-borne vitamin D binding protein (known as Gc protein), as well as B and T lymphocytes. However, in various cancer patients the Gc protein is deglycosylated by serum α-N-acetyl galactosaminidase (Nagalase) secreted from cancer cells. This deglycosylated Gc protein, lacking the N-acetylgalactosamine monosaccharide, cannot be converted to its form of Macrophage Activating Factor, leading to immunosuppression rather than Macrophage activation against cancer cells.
Efranat has developed cancer immunotherapy based on Macrophage Activating Factor produced from natural Gc protein extracted from FDA approved healthy human plasma.
In this phase I study, the treatment is given as Intramuscular, once-weekly injection of EF-022, for two courses, while each course is comprised of 4 injections.
The investigational treatment is expected to enhance immune response, thereby, improve patient's well being, quality of life and disease control.
Primary objectives:
- To determine the safety and tolerability of EF-022 and to define the maximal tolerated dose (MTD) for potential administration.
- To identify the Dose Limiting Toxicity (DLT) of EF-022.
Secondary objectives:
- To determine the 'Recommended Phase 2 Dose' (RP2D) based on MTD data, immunological and pharmacodynamics markers
- To explore preliminary efficacy of EF-022 in advanced solid tumors according to the 'Response Evaluation Criteria in the modified Solid Tumors' (RECIST 1.1) and blood levels of tumor-related markers known to reflect tumor burden.
Exploratory objectives:
- To assess levels of immune-related factors in peripheral blood (determined by FACS analysis), reflecting induced immunological activities, including but not limited to, natural killer (NK), monocytes (M1 and M2) and T cell subpopulations (effector vs regulatory, CD4+ and CD8+ cells), B cells (CD20), myeloid and dendritic cells etc.
- To assess the change in serum levels of protein biomarkers in the blood.
- To immunohistochemically assess and compare tumor derived tissue samples Pre and post treatment. To analyze the infiltration of different population of cells into the tumor bed.
Detailed description
Part 1:
Eligible subjects will be assigned, successively in order of accrual, to one of the three cohorts, to receive intramuscular (IM) injections of EF-022, once weekly for two courses of treatment. Each course will consist of 4 injections with one week intervals (total: 8 weeks of treatment).
Dose escalation will only proceed in the absence of dose-limiting toxicity (DLT) during course 1. For this purpose, each cohort will only begin its first course of EF-022 when the cohort preceding it has successfully completed its first 4-week treatment course without any signs of DLT. During this first course, should 1/3 patients experience DLT, dose escalation for the next cohort will not be authorized; the next cohort will receive the same dose as the one preceding it. If 2 patients or more of all patients treated with a given dose develop DLT, dose escalation will be halted and no more patients will be treated at the DLT dose. The value of MTD will be defined as the EF-022 dose below the dose at which DLT was seen for at least 2 subjects. Upon determination of the MTD, an additional cohort will be opened (confirmatory cohort) and treated with two courses of that dose.
Part 2:
During the expanded cohort, 24 Patients will be allocated to receive either 100ng, 500ng or 1000ng weekly treatment as detailed below: The first 18 patients will be assigned to alternating doses of either 100ng or 500ng in a sequential manner (each patient will be assigned to a single dose), with the caveat that given indications should be assigned equally, as much as possible, between these two doses.
Interim analysis will be performed once the 12th patient reaches Day 57 and the CT results as well as PD analysis are available for at least 12 patients, while at least 18 patients have begun study treatment. A decision regarding adding a 1000ng dose cohort vs. continuing with the 100ng and 500ng doses will be based on a discussion of the interim analysis results.
Each patient will receive 2 courses of treatment, i.e. weekly injections for a total period of 8 weeks, followed by a follow-up period of up to 12 months from the start of treatment (Day 1).
Continuation of treatment after the second course will be at the discretion of the investigator. Patients who will continue extended treatment post course 2 will keep the weekly injection dosage mode and continue therapy until disease progression, development of unacceptable toxicities, non-compliance, inter-current illness that prevents treatment continuation, withdrawal of consent, or change in subject condition that renders the subject unacceptable for further treatment.
All study patients who completed at least two courses of treatment will be followed up until 12 months from day 1 of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A: EF-022 100 ng once weekly | Experimental | Drug: EF-022 (Modified Vitamin D Binding Protein Macrophage Activator)Intra-Muscular injections of EF-022 100 ng once weekly for a period of 8 weeks |
| Cohort B: EF-022 500 ng once weekly | Experimental | Drug: EF-022 (Modified Vitamin D Binding Protein Macrophage Activator)Intra-Muscular injections of EF-022 500 ng once weekly for a period of 8 weeks |
| Cohort C: EF-022 1000 ng once weekly | Experimental | Drug: EF-022 (Modified Vitamin D Binding Protein Macrophage Activator)Intra-Muscular injections of EF-022 1000 ng once weekly for a period of 8 weeks |
| Expanded Cohort | Experimental | Drug: EF-022 (Modified Vitamin D Binding Protein Macrophage Activator)the expanded cohort, 24 Patients will be allocated to receive either 100ng, 500ng or 1000ng weekly treatment as detailed below: The first 18 patients will be assigned to alternating doses of either 100ng or 500ng in a sequential manner (each patient will be assigned to a single dose). A decision regarding adding a 1000ng dose cohort vs. continuing with the 100ng and 500ng doses will be based on a discussion of the interim analysis results. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients diagnosed with inoperable, recurrent or metastatic tumor, deemed incurable, and who have either failed to respond to standard therapy or for whom no standard therapy is available or refuse to receive standard therapies or in case of SCC, the investigator decides that delay of the standard therapy does not have any risk for the patient.
- Histologically or cytological-confirmed diagnosis of solid tumor on file. For the expanded cohort only the following immunological tumors will be recruited: epithelial ovarian cancer, cervical carcinoma, head \& neck cancer, melanoma, kidney cancer (RCC), gastric cancer, lung cancer (SCLC or NSCLC), sarcoma, bladder cancer or squamous cell carcinoma (SCC) of the skin.
- Measurable disease (i.e., present with at least one measurable lesion per modified RECIST, version 1.1).
- Age: 18-80 years.
- BMI: 18-36.
Key exclusion criteria (16 listed)
- Current evidence of active and uncontrolled infection.
- Known Cirrhosis.
- Treatment refractory hypertension (blood pressure of systolic> 150 mmHg and/or diastolic > 95 mm Hg) which cannot be controlled by anti-hypertensive therapy;
- A history or evidence of current Class IV congestive heart failure.
- Current left ventricular ejection fraction < 50%
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 |
|---|---|---|
| EF-022 (Modified Vitamin D Binding Protein Macrophage Activator) | Drug | Cohort A: EF-022 100 ng once weekly, Cohort B: EF-022 500 ng once weekly, Cohort C: EF-022 1000 ng once weekly, Expanded Cohort |
Primary outcome
Number of Adverse Events that meets the DLT definition
Time frame: During first course of treatment (up to 4 weeks)
Percentage of participants with Adverse Events grade 3-4
Time frame: During two courses of treatment (up to 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
Related trials for Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 EF-022 (Modified Vitamin D Binding Protein Macrophage Activator) in people with Solid Tumors, run by Efranat Ltd. at 2 sites in Israel.
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 18 inclusion and 16 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Adverse Events that meets the DLT definition (time frame: During first course of treatment (up to 4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.