MelanomaEarly Phase 1Mel55NCT01425749
Study to Assess Safety and Immune Response of Stage IIB-IV Resected Melanoma After Treatment With MAGE-A3 ASCI
A Early Phase 1 study testing recMAGE-A3 + AS15 ASCI in people with Melanoma, run by Craig L Slingluff, Jr at 1 site in United States.
Trial summary
The goals of this study are to 1) assess the safety of recombinant MAGE-A3 protein combined with AS15 Immunological Adjuvant System (recMAGE-A3 + AS15) as an Antigen-Specific Cancer Immunotherapeutic (MAGE-A3 ASCI) when administered in two different administration sites, intramuscular (IM) or intradermal/subcutaneous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- recMAGE-A3 + AS15 ASCI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Oct 2015
- Phase
- Early 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
- Histologically or cytologically proven melanoma that meets one of the following two criteria:
- Stage IIB-IV melanoma rendered clinically free of disease by surgery, other therapy, or spontaneous remission within 6 months prior to registration.
- Stage III or IV melanoma with disease. Patients may be eligible if there are definite or equivocal findings of persistent or metastatic disease as long as those findings do not meet RECIST criteria for measurable disease.
- Expression of MAGE-A3 by the tumor (primary or metastasis).
- Patients may have had multiple primary melanomas.
- Patients may have had, or may have, a metastasis from a cutaneous, mucosal, unknown primary site.
Show all 26Show fewer
- Patients with brain metastases may be eligible if all of the following are true:
- The total number of brain metastases ever is less than or equal to 3.
- The brain metastases have been completely removed by surgery or have been treated completely by stereotactic radiotherapy. Stereotactic radiotherapy, such as gamma knife, can be used up to 1 week prior to study entry.
- There has been no evident growth of any brain metastasis since treatment.
- No treated brain metastasis is greater than 2 cm in diameter at the time of protocol entry.
- Patients must have at least two intact axillary and/or inguinal lymph node basins.
- The interferon education packet must be completed satisfactorily for those who are eligible for, but refuse, interferon therapy.
- All patients must have:
- ECOG performance status of 0 or 1.
- Ability and willingness to give informed consent.
- Laboratory parameters as follows:
- ANC > 1000/mm3, and Platelets > 75,000/mm3 and Hgb > 9 g/dL
- Hepatic:
- AST and ALT up to 2.5 x upper limits of normal (ULN) Bilirubin up to 2.5 x ULN Alkaline phosphatase up to 2.5 x ULN LDH up to 2x ULN
- Renal:
- Creatinine up to 1.5 x ULN
- Serology:
- HIV negative (antibody screening), Hepatitis C negative
- HGBA1C level of < 7.5%
- Patients must be 18 years or older at study entry
Who cannot join
- Patients with primary ocular melanoma.
- Patients who have had brain metastases unless they meet the criteria outlined in the inclusion criteria
- Patients who are currently receiving systemic cytotoxic chemotherapy, radiation, monoclonal antibody therapy, or other experimental therapy, or who have received this therapy within the preceding 4 weeks. Patients who are currently receiving nitrosoureas or who have received this therapy within the preceding 6 weeks.
- Patients who have received isolated limb infusion (ILI) or isolated limb perfusion (ILP) for melanoma will not be eligible unless they have experienced tumor progression after the ILI/ILP, and the ILI/ILP was not performed within the prior 12 weeks.
- Patients will not be eligible if there is clinically detectable melanoma deemed likely by the investigator to require intervention during the first 12 weeks of the study that would require premature discontinuation.
- Patients with known or suspected allergies to any component of the MAGE-A3 ASCI.
Show all 27Show fewer
- Patients receiving the following medications at study entry or within the preceding 4 weeks are excluded, except as specified below:
- Agents with putative immunomodulating activity, but with the exception of non-steroidal anti-inflammatory agents and topical steroids.
- Antibodies to CTLA-4, PD-1, PD-L1, or CD137 may not have been received in the past 12 weeks, and patients will be eligible only if there has been melanoma progression since that therapy was administered.
- Allergy desensitization injections.
- Systemic corticosteroids, administered parenterally or orally. Inhaled steroids are not permitted. Topical corticosteroids are acceptable, including steroids with very low solubility administered nasally for local effects only.
- Any growth factors (e.g. GM-CSF, G-CSF, erythropoietin).
- Interferon therapy.
- Interleukin-2 or other interleukins.
- Targeted therapies designed to inhibit BRAF, MAPKinase, mTOR, or their signaling pathways.
- Prior active immunotherapy or vaccines for melanoma may be an exclusion criterion in some circumstances. Exceptions to this exclusion criterion are as follows:
- Patients who have recurred or progressed either after or during administration of a melanoma vaccine may be eligible to enroll in this study 12 weeks following their last vaccination.
- Patients may not have been previously administered the synthetic MAGE-A3 protein, though prior vaccinations with up to 4 synthetic MAGE-A3 peptides (up to 16 amino acids in length, each) is allowed.
- Pregnancy or the possibility of becoming pregnant during vaccine administration. Female patients of child-bearing potential must have a negative pregnancy test (urinary or serum beta-HCG) prior to administration of the first MAGE-A3 ASCI dose. Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination. Women must also not be breast feeding. This is consistent with existing standards of practice for vaccine and chemotherapy protocols.
- Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.
- Patients classified according to the New York Heart Association classification as having Class III or IV heart disease.
- Patients with a body weight < 110 lbs because of the amount and frequency with which blood will be drawn, and because of the biopsies required.
- Patients must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Patients with an active autoimmune disorder requiring these therapies are also excluded. The following will not be exclusionary:
- Laboratory evidence of autoimmune disease (e.g. positive ANA titer) without symptoms
- Clinical evidence of vitiligo
- Other forms of depigmenting illness
- Mild arthritis requiring NSAID medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: T Cell Activation and Immune Cell Function in Melanoma Patients Treated With recMAGE-A3 + AS15 Immunological Adjuvant System
The goals of this study are to 1) assess the safety of recombinant MAGE-A3 protein combined with AS15 Immunological Adjuvant System (recMAGE-A3 + AS15) as an Antigen-Specific Cancer Immunotherapeutic (MAGE-A3 ASCI) when administered in two different administration sites, intramuscular (IM) or intradermal/subcutaneous (ID/SC), and 2) to provide preliminary data on the immunological response to ASCI in the injection site microenvironment, in the node draining the vaccine site (sentinel immunized node) and in the blood and whether there are large differences in the magnitude, persistence, or type of immune response induced as a function of the ASCI injection. Evaluation of immune responses to the ASCI will include, amonth others antiMAGE-A3 antibody responses and CD4+ and CD8+ T cell responses.
Read the detailed description
This was an open-label randomized single institution pilot study to evaluate the safety and immunologic response to MAGE-A3 immunotherapeutic administered by either of two injection routes (i.m. or i.d./s.c.). Patients were studied following IRB approval (IRB #15398) and documentation of informed consent. The trial was registered in clinicaltrials.gov (NCT01425749), and was performed at the University of Virginia.
MAGE-A3 immunotherapeutic (0.5 ml) was administered five times (weeks 0, 3, 6, 9, 12) in extremities uninvolved with melanoma. Vaccines 1 and 3 were administered at the same site: other vaccine sites were rotated among available extremities. Subjects were randomized 1:1, within each stratum (AJCC stage II/III or IV), to i.m. (Group A) or i.d./s.c. (Group B) administration. The randomization code was generated by the study statistician using varying block sizes of 2 to 4. For group B patients, half of the dose was injected s.c., then the needle was withdrawn to the dermis, then advanced intradermally from that same puncture site and the remaining half dose was injected i.d. Immune responses were evaluated in a SIN and PBMC.
- Conditions
- Melanoma
- Being tested
- recMAGE-A3 + AS15 ASCI
- Keywords
- melanoma, MAGE-A3, immunotherapy, adjuvant, skin cancer, skin diseases, immunology
- Medical subject headings
- Melanoma, Skin Neoplasms, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recMAGE-A3 + AS15 ASCIBiological
Also called recMAGE-A3 + AS15 ASCI IM, recMAGE-A3 + AS15 ASCI ID/SC
Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Intramuscular injections of recMAGE-A3 + AS15 ASCI. Receives: Biological: recMAGE-A3 + AS15 ASCI |
| Arm B | Experimental | Intradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50. Receives: Biological: recMAGE-A3 + AS15 ASCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events as a Measure of Safety and Tolerability
grade 2 treatment-related adverse events graded by CTCAE v4
Measured: Over 6 months
Enumeration of CD4 and CD8 T Cell Responses to MAGE-A3 Epitopes in the Injection Site-draining Lymph Node (Sentinel Immunized Node, SIN) as a Measure of Immunogenicity.
Flow cytometry on in vitro stimulated lymphocytes. A positive immune response was identified as one with bifunctional CD4+ or CD8+ T cells, producing both TNF alpha and IFN-gamma after exposure to antigen.
Measured: One week after 3 doses of study drug, on day 22.
Secondary outcomes (4)
Enumeration of CD4+ and CD8+ T Cells Reactive to MAGE-A3 Epitopes in Peripheral Blood as a Measure of Immunogenicity.
The analysis determined the proportion of CD4+ (and/or CD8+) T cells producing IFN-gamma or TNFα, or both, in response to MAGE-A3 peptide pools (with irrelevant peptide as negative control). T cell response was defined when T cells producing both IFNγ and TNFα in response to MAGE-A3 peptides exceeded (a) twice the maximum of 2 negative controls (PRAME peptides, media only), corrected for pre-existing response; and (b) exceeded the negative controls by at least 0.2% of the T cell population. These criteria also were used to define immunogenicity by ELIspot (IFNγ only). If the negative control values for a given sample were zero, a meaningful fold-increase could not be calculated; so, in those cases, we used the minimum detectable value among all similar assays (0.06%) as the negative control value for that sample.
Measured: Over 6 months
Identification of Antibody Responses to MAGE-A3 After MAGE-A3 ASCI Administration as a Measure of Immunogenicity.
Antibody responses were assessed in serum by ELISA, assay for IgG. Seroconversion was defined as a detectable Ab response by ELISA (>20 EU/ml).
Measured: Over 6 months, typically weeks 1, 7, 13, 26
Characterization of the Maturation and Activation of Dendritic Cell (DC) Populations in the Sentinel Immunized Node (SIN) After Treatment With MAGE-A3 ASCI.
Number of CD83+ cells (mature DC) and CD1a+ cells (immature DC/Langerhans cells) per mm^2 in cross-sections of sentinel immunized nodes
Measured: Over 3 weeks
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
Cells per mm^2 in the superficial dermis at the vaccine site microenvironment, by enumeration of immunohistochemically stained slides. Biopsies of the vaccine sites were taken at week 1 (1 week after the first vaccine) and week 7 (1 week after the 3rd vaccine). This only was evaluable in Arm B patients.
Measured: Over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2013
- Study completionOct 2015
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 (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig L Slingluff, Jr
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor-investigator, Craig L Slingluff, Jr, University of Virginia
- Investigators
- Craig L Slingluff, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425749
- Sponsor's protocol ID
- CSlingluff
- Acronym
- Mel55
- Status last verified
- Mar 2016
- First submitted
- 19 Jul 2011
- Last updated
- 4 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Slingluff CL Jr, Petroni GR, Olson WC, Smolkin ME, Chianese-Bullock KA, Mauldin IS, Smith KT, Deacon DH, Varhegyi NE, Donnelly SB, Reed CM, Scott K, Galeassi NV, Grosh WW. A randomized pilot trial testing the safety and immunologic effects of a MAGE-A3 protein plus AS15 immunostimulant administered into muscle or into dermal/subcutaneous sites. Cancer Immunol Immunother. 2016 Jan;65(1):25-36. doi: 10.1007/s00262-015-1770-9. Epub 2015 Nov 18.
PubMed 26581199
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T Cell Activation and Immune Cell Function in Melanoma Patients Treated With recMAGE-A3 + AS15 Immunological Adjuvant System
- ClinicalTrials.gov ID
- NCT01425749
- Acronym / sponsor ID
- Mel55 / CSlingluff
- Conditions
- Melanoma
- Keywords
- melanoma, MAGE-A3, immunotherapy, adjuvant, skin cancer, skin diseases, immunology
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Craig L Slingluff, JrUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jun 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 30 Aug 2011 (estimated)
- Results
- Posted 4 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of this study are to 1) assess the safety of recombinant MAGE-A3 protein combined with AS15 Immunological Adjuvant System (recMAGE-A3 + AS15) as an Antigen-Specific Cancer Immunotherapeutic (MAGE-A3 ASCI) when administered in two different administration sites, intramuscular (IM) or intradermal/subcutaneous (ID/SC), and 2) to provide preliminary data on the immunological response to ASCI in the injection site microenvironment, in the node draining the vaccine site (sentinel immunized node) and in the blood and whether there are large differences in the magnitude, persistence, or type of immune response induced as a function of the ASCI injection. Evaluation of immune responses to the ASCI will include, amonth others antiMAGE-A3 antibody responses and CD4+ and CD8+ T cell responses.
Detailed description
This was an open-label randomized single institution pilot study to evaluate the safety and immunologic response to MAGE-A3 immunotherapeutic administered by either of two injection routes (i.m. or i.d./s.c.). Patients were studied following IRB approval (IRB #15398) and documentation of informed consent. The trial was registered in clinicaltrials.gov (NCT01425749), and was performed at the University of Virginia.
MAGE-A3 immunotherapeutic (0.5 ml) was administered five times (weeks 0, 3, 6, 9, 12) in extremities uninvolved with melanoma. Vaccines 1 and 3 were administered at the same site: other vaccine sites were rotated among available extremities. Subjects were randomized 1:1, within each stratum (AJCC stage II/III or IV), to i.m. (Group A) or i.d./s.c. (Group B) administration. The randomization code was generated by the study statistician using varying block sizes of 2 to 4. For group B patients, half of the dose was injected s.c., then the needle was withdrawn to the dermis, then advanced intradermally from that same puncture site and the remaining half dose was injected i.d. Immune responses were evaluated in a SIN and PBMC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: recMAGE-A3 + AS15 ASCIIntramuscular injections of recMAGE-A3 + AS15 ASCI. |
| Arm B | Experimental | Biological: recMAGE-A3 + AS15 ASCIIntradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Histologically or cytologically proven melanoma that meets one of the following two criteria:
- Expression of MAGE-A3 by the tumor (primary or metastasis).
- Patients may have had multiple primary melanomas.
- Patients may have had, or may have, a metastasis from a cutaneous, mucosal, unknown primary site.
- Patients with brain metastases may be eligible if all of the following are true:
Key exclusion criteria (27 listed)
- Patients with primary ocular melanoma.
- Patients who have had brain metastases unless they meet the criteria outlined in the inclusion criteria
- Patients who are currently receiving systemic cytotoxic chemotherapy, radiation, monoclonal antibody therapy, or other experimental therapy, or who have received this therapy within the preceding 4 weeks. Patients who are currently receiving nitrosoureas or who have received this therapy within the preceding 6 weeks.
- Patients who have received isolated limb infusion (ILI) or isolated limb perfusion (ILP) for melanoma will not be eligible unless they have experienced tumor progression after the ILI/ILP, and the ILI/ILP was not performed within the prior 12 weeks.
- Patients will not be eligible if there is clinically detectable melanoma deemed likely by the investigator to require intervention during the first 12 weeks of the study that would require premature discontinuation.
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 |
|---|---|---|
| recMAGE-A3 + AS15 ASCIAlso: recMAGE-A3 + AS15 ASCI IM, recMAGE-A3 + AS15 ASCI ID/SCInjections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit. | Biological | Arm A, Arm B |
Primary outcome
Number of Participants With Treatment-related Adverse Events as a Measure of Safety and Tolerability
Time frame: Over 6 months
grade 2 treatment-related adverse events graded by CTCAE v4
Enumeration of CD4 and CD8 T Cell Responses to MAGE-A3 Epitopes in the Injection Site-draining Lymph Node (Sentinel Immunized Node, SIN) as a Measure of Immunogenicity.
Time frame: One week after 3 doses of study drug, on day 22.
Flow cytometry on in vitro stimulated lymphocytes. A positive immune response was identified as one with bifunctional CD4+ or CD8+ T cells, producing both TNF alpha and IFN-gamma after exposure to antigen.
4 secondary outcomes
Enumeration of CD4+ and CD8+ T Cells Reactive to MAGE-A3 Epitopes in Peripheral Blood as a Measure of Immunogenicity.
Time frame: Over 6 months
Identification of Antibody Responses to MAGE-A3 After MAGE-A3 ASCI Administration as a Measure of Immunogenicity.
Time frame: Over 6 months, typically weeks 1, 7, 13, 26
Characterization of the Maturation and Activation of Dendritic Cell (DC) Populations in the Sentinel Immunized Node (SIN) After Treatment With MAGE-A3 ASCI.
Time frame: Over 3 weeks
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
Time frame: Over 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26581199Slingluff CL Jr, Petroni GR, Olson WC, Smolkin ME, Chianese-Bullock KA, Mauldin IS, Smith KT, Deacon DH, Varhegyi NE, Donnelly SB, Reed CM, Scott K, Galeassi NV, Grosh WW. A randomized pilot trial testing the safety and immunologic effects of a MAGE-A3 protein plus AS15 immunostimulant administered into muscle or into dermal/subcutaneous sites. Cancer Immunol Immunother. 2016 Jan;65(1):25-36. doi: 10.1007/s00262-015-1770-9. Epub 2015 Nov 18.
Related trials for Melanoma
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
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Craig L Slingluff, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing recMAGE-A3 + AS15 ASCI in people with Melanoma, run by Craig L Slingluff, Jr 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 26 inclusion and 27 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 4 Apr 2016. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 4 Apr 2016). 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?
Number of Participants With Treatment-related Adverse Events as a Measure of Safety and Tolerability (time frame: Over 6 months). 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?
On the ClinicalTrials.gov record for NCT01425749, which also lists 1 linked publication.
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 4 Apr 2016.