Pancreas CancerPhase 1NCT02021422
A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy
A Phase 1 study testing anakinra, Oxaliplatin and Irinotecan in people with Pancreas Cancer, run by Baylor Research Institute at 1 site in United States.
Trial summary
The study's overall objectives are to evaluate the safety of anakinra in combination with standard chemotherapy regimens in patients with pancreatic ductal adenocarinoma, as well as to collect preliminary immune modulation and clinical activity information, overall survival, and serious adverse events related to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- anakinra, Oxaliplatin and Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jun 2021
- 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
- 18 years of age or older
- Male or non-pregnant and non-lactating female
- Confirmed metastatic/inoperable metastatic pancreas cancer and/or Histologically/cytologically confirmed metastatic adenocarcinoma of pancreas
- Patients' blood counts and blood chemistry levels at baseline must be not clinically significant (NCS) as determined by the enrolling investigator.
- Patient has Eastern Cooperative Oncology Group( ECOG ) Performance Status 0 to 2 (refer to Appendix 5):
- Signed study consent form
Who cannot join
- <18 years of age
- Pregnant or lactating female
- Patient has islet cell neoplasms
- Active secondary malignancies (2nd cancer not treated/present)
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- Known infection with hepatitis B, hepatitis C, or cirrhosis
Show all 14Show fewer
- Major surgery or vascular device placement (excluding ports for IV medication/chemotherapy) within 2 weeks prior to Day 1 of treatment in study
- History of allergy or hypersensitivity to the study drugs
- Patient is enrolled in any concurrent-outside (outside Baylor University Medical Center or Texas Oncology) clinical protocol or investigational trial
- Significant cardiac disease as defined as New York Heart Association (NYHA) classification III or IV, uncontrolled CHF, or prior MI last 6-months
- Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation which in the opinion of the investigator may place the patient at increased risk
- Peripheral sensory neuropathy ≥ to grade 2 at baseline
- Significant co-morbidities deemed by investigator as unsuitable for participation/enrollment
- Study consent form not signed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy Regimens in Metastatic Pancreatic Ductal Adenocarcinoma Patients
The study's overall objectives are to evaluate the safety of anakinra in combination with standard chemotherapy regimens in patients with pancreatic ductal adenocarinoma, as well as to collect preliminary immune modulation and clinical activity information, overall survival, and serious adverse events related to the study drug.
Read the detailed description
Kineret (anakinra) is a FDA-approved drug indicated for rheumatoid arthritis. Anakinra is a recombinant, nonglycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra). Anakinra blocks the biologic activity of IL -1 by competitively inhibiting IL-1 binding to the interleukin-1 type I receptor (IL-1RI), which is expressed in a wide variety of tissues and organs. IL-1 production is induced in response to inflammatory stimuli and mediates various physiologic effects including inflammatory and immunological responses.
This is a pilot, prospective, non-randomized, consecutive enrollment study that will enroll up to 12 subjects who meet the study defined inclusion and exclusion criteria.
Subjects will undergo standard of care chemotherapy treatment/regimens (i.e., modified FOLFIRINOX). Subjects will be dispensed a 2 weeks supply of anakinra the day they begin chemotherapy. They will be instructed to begin self-administering the anakinra (study drug) injections the day after their first dose of chemotherapy.
They will have a blood sample collected at baseline and 6 months follow up. If they have surgery for their disease, they may have a tissue sample collected for later analysis.
- Conditions
- Pancreas Cancer
- Being tested
- anakinra, Oxaliplatin, Irinotecan, fluorouracil
- Keywords
- metastatic pancreatic ductal adenocarcinoma (PDAC), pancreatic cancer, pancreas cancer, pancreatic adenocarcinoma, metastatic pancreas cancer, metastatic pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anakinraDrug
Also called Kineret
Dosage Route Administration 100 mg SC Every Other Day
OxaliplatinDrug
Oxaliplatin 85 mg/m2 2-4 hours
IrinotecanDrug
Also called Camptosar
Irinotecan 180 mg/m2 90 minutes
fluorouracilDrug
Also called 5 FU
fluorouracil 2400 mg/m2 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Anakinra with Modified Folfirinox | Other | 8-weeks of anakinra and modified FOLFIRINOX regimen (refer to Appendix 9 for regimen) as follows
Kineret (anakinra) Dosage Route Administration 100 mg SC Every Other Day
Modified FOLFIRINOX Drug Dose Administration Oxaliplatin 85 mg/m2 2-4 hours Irinotecan 180 mg/m2 90 minutes fluorouracil 2400 mg/m2 48 hours Receives: Drug: anakinra; Drug: Oxaliplatin; Drug: Irinotecan; Drug: fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants with SAEs and AEs.
Test the safety of Anakinra in combination with standard chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) as evidenced by the Number of Participants with serious adverse events (SAEs) and adverse events (AEs).
Measured: 6 months
Secondary outcomes (4)
Overall Survival
Overall Survival (OS) rate as defined by the percentage of people who are alive for a certain period of time after diagnosis
Measured: 6 months
Adverse events associated with injection site reactions and the incidence of infections
Adverse events associated with injection site reactions and the incidence of infections
Measured: 6 Months
Data Collection: tumor measurements by CT scans
Data Collection: tumor measurements by CT scans
Measured: 6 months
Gather preliminary information on the immune modulation and clinical activity of this therapy
- Blood transcriptional profiling
- Composition of white blood cells
- Assessment of PDAC antigen--specific T cell repertoire in the blood
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2017
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Becerra, MD, Principal investigator, Baylor Sammons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021422
- Sponsor's protocol ID
- 013-018
- Status last verified
- Nov 2025
- First submitted
- 20 Dec 2013
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Allantaz F, Chaussabel D, Stichweh D, Bennett L, Allman W, Mejias A, Ardura M, Chung W, Smith E, Wise C, Palucka K, Ramilo O, Punaro M, Banchereau J, Pascual V. Blood leukocyte microarrays to diagnose systemic onset juvenile idiopathic arthritis and follow the response to IL-1 blockade. J Exp Med. 2007 Sep 3;204(9):2131-44. doi: 10.1084/jem.20070070. Epub 2007 Aug 27.
PubMed 17724127Aspord C, Pedroza-Gonzalez A, Gallegos M, Tindle S, Burton EC, Su D, Marches F, Banchereau J, Palucka AK. Breast cancer instructs dendritic cells to prime interleukin 13-secreting CD4+ T cells that facilitate tumor development. J Exp Med. 2007 May 14;204(5):1037-47. doi: 10.1084/jem.20061120. Epub 2007 Apr 16.
PubMed 17438063Beatty GL, Chiorean EG, Fishman MP, Saboury B, Teitelbaum UR, Sun W, Huhn RD, Song W, Li D, Sharp LL, Torigian DA, O'Dwyer PJ, Vonderheide RH. CD40 agonists alter tumor stroma and show efficacy against pancreatic carcinoma in mice and humans. Science. 2011 Mar 25;331(6024):1612-6. doi: 10.1126/science.1198443.
PubMed 21436454Bennett L, Palucka AK, Arce E, Cantrell V, Borvak J, Banchereau J, Pascual V. Interferon and granulopoiesis signatures in systemic lupus erythematosus blood. J Exp Med. 2003 Mar 17;197(6):711-23. doi: 10.1084/jem.20021553.
PubMed 12642603Chaussabel D, Quinn C, Shen J, Patel P, Glaser C, Baldwin N, Stichweh D, Blankenship D, Li L, Munagala I, Bennett L, Allantaz F, Mejias A, Ardura M, Kaizer E, Monnet L, Allman W, Randall H, Johnson D, Lanier A, Punaro M, Wittkowski KM, White P, Fay J, Klintmalm G, Ramilo O, Palucka AK, Banchereau J, Pascual V. A modular analysis framework for blood genomics studies: application to systemic lupus erythematosus. Immunity. 2008 Jul 18;29(1):150-64. doi: 10.1016/j.immuni.2008.05.012.
PubMed 18631455Coussens LM, Zitvogel L, Palucka AK. Neutralizing tumor-promoting chronic inflammation: a magic bullet? Science. 2013 Jan 18;339(6117):286-91. doi: 10.1126/science.1232227.
PubMed 23329041De Monte L, Reni M, Tassi E, Clavenna D, Papa I, Recalde H, Braga M, Di Carlo V, Doglioni C, Protti MP. Intratumor T helper type 2 cell infiltrate correlates with cancer-associated fibroblast thymic stromal lymphopoietin production and reduced survival in pancreatic cancer. J Exp Med. 2011 Mar 14;208(3):469-78. doi: 10.1084/jem.20101876. Epub 2011 Feb 21.
PubMed 21339327Kalos M, Levine BL, Porter DL, Katz S, Grupp SA, Bagg A, June CH. T cells with chimeric antigen receptors have potent antitumor effects and can establish memory in patients with advanced leukemia. Sci Transl Med. 2011 Aug 10;3(95):95ra73. doi: 10.1126/scitranslmed.3002842.
PubMed 21832238Kuraishy A, Karin M, Grivennikov SI. Tumor promotion via injury- and death-induced inflammation. Immunity. 2011 Oct 28;35(4):467-77. doi: 10.1016/j.immuni.2011.09.006.
PubMed 22035839La Torre M, Nigri G, Ferrari L, Cosenza G, Ravaioli M, Ramacciato G. Hospital volume, margin status, and long-term survival after pancreaticoduodenectomy for pancreatic adenocarcinoma. Am Surg. 2012 Feb;78(2):225-9.
PubMed 22369834Laheru D, Jaffee EM. Immunotherapy for pancreatic cancer - science driving clinical progress. Nat Rev Cancer. 2005 Jun;5(6):459-67. doi: 10.1038/nrc1630.
PubMed 15905855Lee HC, Ziegler SF. Inducible expression of the proallergic cytokine thymic stromal lymphopoietin in airway epithelial cells is controlled by NFkappaB. Proc Natl Acad Sci U S A. 2007 Jan 16;104(3):914-9. doi: 10.1073/pnas.0607305104. Epub 2007 Jan 9.
PubMed 17213320Maker AV, Katabi N, Qin LX, Klimstra DS, Schattner M, Brennan MF, Jarnagin WR, Allen PJ. Cyst fluid interleukin-1beta (IL1beta) levels predict the risk of carcinoma in intraductal papillary mucinous neoplasms of the pancreas. Clin Cancer Res. 2011 Mar 15;17(6):1502-8. doi: 10.1158/1078-0432.CCR-10-1561. Epub 2011 Jan 25.
PubMed 21266527Palucka AK, Gatlin J, Blanck JP, Melkus MW, Clayton S, Ueno H, Kraus ET, Cravens P, Bennett L, Padgett-Thomas A, Marches F, Islas-Ohlmayer M, Garcia JV, Banchereau J. Human dendritic cell subsets in NOD/SCID mice engrafted with CD34+ hematopoietic progenitors. Blood. 2003 Nov 1;102(9):3302-10. doi: 10.1182/blood-2003-02-0384. Epub 2003 Jul 17.
PubMed 12869510Palucka AK, Ueno H, Connolly J, Kerneis-Norvell F, Blanck JP, Johnston DA, Fay J, Banchereau J. Dendritic cells loaded with killed allogeneic melanoma cells can induce objective clinical responses and MART-1 specific CD8+ T-cell immunity. J Immunother. 2006 Sep-Oct;29(5):545-57. doi: 10.1097/01.cji.0000211309.90621.8b.
PubMed 16971810
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy Regimens in Metastatic Pancreatic Ductal Adenocarcinoma Patients
- ClinicalTrials.gov ID
- NCT02021422
- Acronym / sponsor ID
- 013-018
- Conditions
- Pancreas Cancer
- Keywords
- metastatic pancreatic ductal adenocarcinoma (PDAC), pancreatic cancer, pancreas cancer, pancreatic adenocarcinoma, metastatic pancreas cancer, metastatic pancreatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 27 Dec 2013 (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.
The study's overall objectives are to evaluate the safety of anakinra in combination with standard chemotherapy regimens in patients with pancreatic ductal adenocarinoma, as well as to collect preliminary immune modulation and clinical activity information, overall survival, and serious adverse events related to the study drug.
Detailed description
Kineret (anakinra) is a FDA-approved drug indicated for rheumatoid arthritis. Anakinra is a recombinant, nonglycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra). Anakinra blocks the biologic activity of IL -1 by competitively inhibiting IL-1 binding to the interleukin-1 type I receptor (IL-1RI), which is expressed in a wide variety of tissues and organs. IL-1 production is induced in response to inflammatory stimuli and mediates various physiologic effects including inflammatory and immunological responses.
This is a pilot, prospective, non-randomized, consecutive enrollment study that will enroll up to 12 subjects who meet the study defined inclusion and exclusion criteria.
Subjects will undergo standard of care chemotherapy treatment/regimens (i.e., modified FOLFIRINOX). Subjects will be dispensed a 2 weeks supply of anakinra the day they begin chemotherapy. They will be instructed to begin self-administering the anakinra (study drug) injections the day after their first dose of chemotherapy.
They will have a blood sample collected at baseline and 6 months follow up. If they have surgery for their disease, they may have a tissue sample collected for later analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anakinra with Modified Folfirinox | Other | Drug: anakinra, Drug: Oxaliplatin, Drug: Irinotecan, Drug: fluorouracil8-weeks of anakinra and modified FOLFIRINOX regimen (refer to Appendix 9 for regimen) as follows Kineret (anakinra) Dosage Route Administration 100 mg SC Every Other Day Modified FOLFIRINOX Drug Dose Administration Oxaliplatin 85 mg/m2 2-4 hours Irinotecan 180 mg/m2 90 minutes fluorouracil 2400 mg/m2 48 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Male or non-pregnant and non-lactating female
- Confirmed metastatic/inoperable metastatic pancreas cancer and/or Histologically/cytologically confirmed metastatic adenocarcinoma of pancreas
- Patients' blood counts and blood chemistry levels at baseline must be not clinically significant (NCS) as determined by the enrolling investigator.
- Patient has Eastern Cooperative Oncology Group( ECOG ) Performance Status 0 to 2 (refer to Appendix 5):
Key exclusion criteria (14 listed)
- <18 years of age
- Pregnant or lactating female
- Patient has islet cell neoplasms
- Active secondary malignancies (2nd cancer not treated/present)
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
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 |
|---|---|---|
| anakinraAlso: KineretDosage Route Administration 100 mg SC Every Other Day | Drug | Anakinra with Modified Folfirinox |
| OxaliplatinOxaliplatin 85 mg/m2 2-4 hours | Drug | Anakinra with Modified Folfirinox |
| IrinotecanAlso: CamptosarIrinotecan 180 mg/m2 90 minutes | Drug | Anakinra with Modified Folfirinox |
| fluorouracilAlso: 5 FUfluorouracil 2400 mg/m2 48 hours | Drug | Anakinra with Modified Folfirinox |
Primary outcome
The Number of Participants with SAEs and AEs.
Time frame: 6 months
Test the safety of Anakinra in combination with standard chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) as evidenced by the Number of Participants with serious adverse events (SAEs) and adverse events (AEs).
4 secondary outcomes
Overall Survival
Time frame: 6 months
Adverse events associated with injection site reactions and the incidence of infections
Time frame: 6 Months
Data Collection: tumor measurements by CT scans
Time frame: 6 months
Gather preliminary information on the immune modulation and clinical activity of this therapy
Time frame: 6 month
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 18 Feb 2026.
- Background: PubMed 17724127Allantaz F, Chaussabel D, Stichweh D, Bennett L, Allman W, Mejias A, Ardura M, Chung W, Smith E, Wise C, Palucka K, Ramilo O, Punaro M, Banchereau J, Pascual V. Blood leukocyte microarrays to diagnose systemic onset juvenile idiopathic arthritis and follow the response to IL-1 blockade. J Exp Med. 2007 Sep 3;204(9):2131-44. doi: 10.1084/jem.20070070. Epub 2007 Aug 27.
- Background: PubMed 17438063Aspord C, Pedroza-Gonzalez A, Gallegos M, Tindle S, Burton EC, Su D, Marches F, Banchereau J, Palucka AK. Breast cancer instructs dendritic cells to prime interleukin 13-secreting CD4+ T cells that facilitate tumor development. J Exp Med. 2007 May 14;204(5):1037-47. doi: 10.1084/jem.20061120. Epub 2007 Apr 16.
- Background: PubMed 21436454Beatty GL, Chiorean EG, Fishman MP, Saboury B, Teitelbaum UR, Sun W, Huhn RD, Song W, Li D, Sharp LL, Torigian DA, O'Dwyer PJ, Vonderheide RH. CD40 agonists alter tumor stroma and show efficacy against pancreatic carcinoma in mice and humans. Science. 2011 Mar 25;331(6024):1612-6. doi: 10.1126/science.1198443.
- Background: PubMed 12642603Bennett L, Palucka AK, Arce E, Cantrell V, Borvak J, Banchereau J, Pascual V. Interferon and granulopoiesis signatures in systemic lupus erythematosus blood. J Exp Med. 2003 Mar 17;197(6):711-23. doi: 10.1084/jem.20021553.
- Background: PubMed 18631455Chaussabel D, Quinn C, Shen J, Patel P, Glaser C, Baldwin N, Stichweh D, Blankenship D, Li L, Munagala I, Bennett L, Allantaz F, Mejias A, Ardura M, Kaizer E, Monnet L, Allman W, Randall H, Johnson D, Lanier A, Punaro M, Wittkowski KM, White P, Fay J, Klintmalm G, Ramilo O, Palucka AK, Banchereau J, Pascual V. A modular analysis framework for blood genomics studies: application to systemic lupus erythematosus. Immunity. 2008 Jul 18;29(1):150-64. doi: 10.1016/j.immuni.2008.05.012.
- Background: PubMed 23329041Coussens LM, Zitvogel L, Palucka AK. Neutralizing tumor-promoting chronic inflammation: a magic bullet? Science. 2013 Jan 18;339(6117):286-91. doi: 10.1126/science.1232227.
- Background: PubMed 21339327De Monte L, Reni M, Tassi E, Clavenna D, Papa I, Recalde H, Braga M, Di Carlo V, Doglioni C, Protti MP. Intratumor T helper type 2 cell infiltrate correlates with cancer-associated fibroblast thymic stromal lymphopoietin production and reduced survival in pancreatic cancer. J Exp Med. 2011 Mar 14;208(3):469-78. doi: 10.1084/jem.20101876. Epub 2011 Feb 21.
- Background: PubMed 21832238Kalos M, Levine BL, Porter DL, Katz S, Grupp SA, Bagg A, June CH. T cells with chimeric antigen receptors have potent antitumor effects and can establish memory in patients with advanced leukemia. Sci Transl Med. 2011 Aug 10;3(95):95ra73. doi: 10.1126/scitranslmed.3002842.
- Background: PubMed 22035839Kuraishy A, Karin M, Grivennikov SI. Tumor promotion via injury- and death-induced inflammation. Immunity. 2011 Oct 28;35(4):467-77. doi: 10.1016/j.immuni.2011.09.006.
- Background: PubMed 22369834La Torre M, Nigri G, Ferrari L, Cosenza G, Ravaioli M, Ramacciato G. Hospital volume, margin status, and long-term survival after pancreaticoduodenectomy for pancreatic adenocarcinoma. Am Surg. 2012 Feb;78(2):225-9.
- Background: PubMed 15905855Laheru D, Jaffee EM. Immunotherapy for pancreatic cancer - science driving clinical progress. Nat Rev Cancer. 2005 Jun;5(6):459-67. doi: 10.1038/nrc1630.
- Background: PubMed 17213320Lee HC, Ziegler SF. Inducible expression of the proallergic cytokine thymic stromal lymphopoietin in airway epithelial cells is controlled by NFkappaB. Proc Natl Acad Sci U S A. 2007 Jan 16;104(3):914-9. doi: 10.1073/pnas.0607305104. Epub 2007 Jan 9.
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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.
Carlos Becerra, MD principal investigator
Baylor Sammons Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing anakinra, Oxaliplatin and Irinotecan in people with Pancreas Cancer, run by Baylor Research Institute 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 6 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: finished, as of the sponsor's last update on 18 Feb 2026. 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?
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?
The Number of Participants with SAEs and AEs. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02021422, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.