Ovarian CancerPhase 2NCT03042702
A Phase 2 Study of Kevetrin in Subjects With Ovarian Cancer
A Phase 2 study testing Kevetrin in people with Ovarian Cancer, run by Innovation Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
Cellceutix has developed Kevetrin (thioureidobutyronitrile), belonging to an anti-proliferative p53 activator pharmacological class, for the treatment of cancer. Nonclinical studies have demonstrated that Kevetrin induces apoptosis by activation of wild type p53 and induces apoptosis in mutant p53 cells by degradation… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Kevetrin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Feb 2017to 10 Nov 2017
- Phase
- Phase 2
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of a personally signed and dated written informed consent to participate in the clinical study
- Non-pregnant female adults at least 18 years of age at time of informed consent
- Histologically confirmed serous epithelial ovarian cancer with peritoneal metastases
- Platinum resistant/refractory disease, defined as disease progression/relapse within 6 months following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively
- Measurable disease, as determined by radiologist evaluator, with at least 1 unidimensional measurable lesion (target lesion) by RECIST v.1.1 that has not previously been irradiated or biopsied
- Presence of non-target lesions that have not previously been irradiated or biopsied; to allow for collection of needle-biopsies at Screening and after completion of Kevetrin treatment
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic and organ function as confirmed by laboratory values at Screening:
- Bone marrow function: Absolute neutrophil count (ANC) ≥ 1500 Cells/μL (with no evidence that this ANC was induced or supported by granulocyte colony stimulating factors)
- Hemoglobin ≥ 9 g/dL (with no RBC transfusions within 7 days of Screening)
- Platelets ≥ 100,000 cells/μL (with no evidence that this platelet count was induced or supported by a platelet-stimulating agent)
- Renal function: creatinine ≤ 1.5 x ULN
- Hepatic function: total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 3 x ULN; alkaline phosphatase ≤ 2.5 x ULN
- Neurologic function: neuropathy (sensory and motor) ≤ CTCAE Grade 1
- Coagulation status: prothrombin time (PT) ≤ 1.5 ULN or INR within normal limits; and partial thromboplastin time (PTT) ≤ 1.2 × ULN
- Women of child-bearing potential are required to use effective contraception throughout the study period. Effective contraception methods include:
- Total abstinence (if this is the usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. (Subject must agree to use contraception should they become sexually active while on the study.)
- Surgical sterilization (hysterectomy and/or bilateral oophorectomy) or tubal ligation at least six weeks before start of study treatment.
- Male partner sterilization, occurring at least 6 months prior to screening. For female subjects on the study, the vasectomized male partner should be their sole partner.
- Double barrier method: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
- Oral*/ injected/ implanted/ transdermal hormonal contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), e.g., hormone vaginal ring.
- Intrauterine device or intrauterine system. *Stable oral contraception use (on the same pill) for a minimum of 3 months before taking study treatment.
- Women are considered post-menopausal and not of child-bearing potential if they have had 12 consecutive months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical hysterectomy and/or bilateral oophorectomy or tubal ligation at least six weeks ago.
- Estimated life expectancy of at least 6 months, in the Investigator's opinion
- Willing and able to comply with scheduled visits, study assessments and laboratory tests, and other study procedures
Who cannot join
- Unwilling to allow removal of tumor biological samples for analysis, i.e., biopsies of tumor lesions, and/or collection of ascites fluid from abdominal ascites (if present)
- Non epithelial tumor, including malignant mixed Müllerian tumors without high grade serous component, or ovarian tumors with low malignant potential (i.e., borderline tumors)
- Known presence of central nervous system metastases
- Presence of tumor metastases causing significant pleural disease/effusion unilaterally or bilaterally (significant pleural effusion is defined by need for thoracentesis more frequently than once every 21 days)
- Presence of ascites that requires paracentesis more frequently than once every 21 days.
- A history of another primary cancer that has been active or treated within the past 3 years prior to start of study treatment, with the exception of adequately treated/resected: basal cell or squamous cell skin carcinoma or actinic keratoses; or carcinoma in situ of the breast or of the cervix; or non-invasive malignant colon polyps
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- Persistent toxic effects with severity of CTCAE grade 2 or greater (excluding alopecia) caused by previous treatment
- History of arterial or deep venous thromboembolism within the 12 months prior to enrollment
- Clinically significant cardiac disease, including:
- Myocardial infarction or unstable angina < 6 months prior to enrollment
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- Cardiac arrhythmia requiring medication (does not include asymptomatic atrial fibrillation with controlled ventricular rate)
- Electrocardiogram (ECG) obtained at Screening which shows QTc prolongation or other medically relevant abnormalities which may affect subject safety or interpretation of study results
- At a higher than average risk, in the Investigator's opinion, of bowel perforation (e.g., symptoms of partial or complete bowel obstruction, recent (within 6 months) history of fistula or bowel perforation, requirement for total parenteral nutrition and continuous hydration)
- Active or chronic recurrent systemic infections that require continuous antimicrobial therapy during the Kevetrin study period
- Past medical history of infection with HIV, hepatitis B or hepatitis C
- Ongoing or recent history of any other uncontrolled and/or clinically significant systemic disease or condition which, in the Investigator's medical opinion, should exclude participation in the study
- Less than 3 weeks between major surgery and planned start of study treatment; major incisions must have healed
- Less than 4 weeks since last treatment for ovarian cancer
- Any investigational or experimental therapy or procedure or participation in any interventional trial within 4 weeks or 5 half-lives (whichever is longer) prior to start of study treatment
- Women of child-bearing potential who are pregnant or nursing (lactating)
- Previous participation in a clinical study of Kevetrin
- History of alcohol or substance abuse, unless in full remission for more than 6 months prior to start of study treatment
- Any other severe acute or chronic medical or psychiatric condition or test abnormality(ies) that, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cancer Research
Dallas, Texas, 75230
Cancer Research
Lebanon, New Hampshire, 03766
About this study
Official title: A Phase 2 Study of Kevetrin (Thioureidobutyronitrile) in Subjects With Platinum-Resistant/Refractory Ovarian Cancer
Cellceutix has developed Kevetrin (thioureidobutyronitrile), belonging to an anti-proliferative p53 activator pharmacological class, for the treatment of cancer. Nonclinical studies have demonstrated that Kevetrin induces apoptosis by activation of wild type p53 and induces apoptosis in mutant p53 cells by degradation of oncogenic mutant p53.
In this Phase 2 study, two different short-term treatment regimens of Kevetrin will be evaluated for safety, tolerability, changes in biomarkers/objective tumor response, and to evaluate the pharmacokinetics of Kevetrin when administered to subjects with platinum-resistant/refractory ovarian cancer.
Read the detailed description
This is an open label, dose-escalation trial to study the safety, biomarker changes (including modulation of p53), objective tumor response changes, and pharmacokinetics following administration of two different treatment regimens of Kevetrin over a 3-week period to subjects with platinum-resistant/refractory ovarian cancer. Following the 3 weeks of Kevetrin dosing, subjects are to be followed up for 3 weeks after completion of Kevetrin treatment. Standard of care treatment, as medically appropriate and per local guidelines, outside of this study protocol can commence after the collection of the post-Kevetrin treatment biomarker samples (collected on Day 21±1 day). The patient population recruited into this study includes those ovarian cancer patients that have platinum resistant/refractory disease, defined as disease progression/relapse within 6 months following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively. Patients may or may not have had additional treatment (e.g., Doxil) prior to entry in this study.
A total of approximately 10 study participants are planned to be enrolled in two cohorts of approximately 5 subjects per cohort, with enrollment in a sequential, dose-escalating fashion. Investigators and subjects will be aware of the treatment cohort into which they are recruiting. Cohort details and the planned doses are:
Cohort 1 (n=5) Kevetrin Cycle - Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses); Follow-up for 3 weeks after Kevetrin treatment ends Cohort 2 (n=5) Kevetrin Cycle - Kevetrin 350 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (1050 mg/m2 per week), for 3 weeks (single cycle; total 9 doses); Follow-up for 3 weeks after Kevetrin treatment ends Cohorts 1 and 2 will be conducted in a sequential fashion, with safety data from cohort 1 evaluated by an independent Data Monitoring Committee (DMC). The DMC will make appropriate recommendations based on the available safety data as regards the intent of progressing to the higher dose cohort 2.
- Conditions
- Ovarian Cancer
- Being tested
- Kevetrin
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KevetrinDrug
Also called Cohort
Kevetrin dose to associated cohort
KevetrinDrug
Kevetrin dose to associated cohort
| Study group | Role | What they receive |
|---|---|---|
| Kevetrin 250 mg/m2 IV Cohort 1 | Experimental | Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends Receives: Drug: Kevetrin |
| Kevetrin 350 mg/m2 IV Cohort 2 | Experimental | Kevetrin 350 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (1050 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends Receives: Drug: Kevetrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events
Reporting of Adverse Events, and severity of adverse events
Measured: 6 Weeks
Number of Participants With Changes in Biomarkers
Changes in RNA and/or protein level of pre-specified biomarkers associated with the p53 signalling pathway and apoptosis will be compared between pre-treatment sample (tumor biopsy, ascites fluid, and peripheral blood) and post-treatment sample (tumor biopsy, ascites fluid, and peripheral blood)
Measured: 3 Weeks
Secondary outcomes (4)
Number of Participants by RECIST Tumor Response Category
Number of subjects in each response category (complete response, partial response, stable disease or progressive disease) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
CR (Complete Response): Disappearance of all target lesions PR (Partial Response) : At least a 30% decrease in the sum of the longest diameters of target lesions PD (Progressive Disease) : At least a 20% increase in the sum of the longest diameters of target lesions SD (Stable Disease) : Small changes that do not meet above criteria
Measured: 3 Weeks
Maximum Plasma Concentration of Kevetrin (Cmax) on Days 1 and 5
Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.
Measured: Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour
Time to Reach the Maximum Plasma Concentration of Kevetrin (Tmax) on Days 1 and 5
Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.
Measured: Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUCt) on Days 1 and 5
Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.
Measured: Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start9 Feb 2017
- Primary completion10 Nov 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovation Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arthur Bertolino, MD, Study director, Cellceutix Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042702
- Sponsor's protocol ID
- CTIX-KEV-201
- Status last verified
- Dec 2018
- First submitted
- 1 Feb 2017
- Last updated
- 27 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Kevetrin (Thioureidobutyronitrile) in Subjects With Platinum-Resistant/Refractory Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03042702
- Acronym / sponsor ID
- CTIX-KEV-201
- Conditions
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Innovation Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Posted 27 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cellceutix has developed Kevetrin (thioureidobutyronitrile), belonging to an anti-proliferative p53 activator pharmacological class, for the treatment of cancer. Nonclinical studies have demonstrated that Kevetrin induces apoptosis by activation of wild type p53 and induces apoptosis in mutant p53 cells by degradation of oncogenic mutant p53.
In this Phase 2 study, two different short-term treatment regimens of Kevetrin will be evaluated for safety, tolerability, changes in biomarkers/objective tumor response, and to evaluate the pharmacokinetics of Kevetrin when administered to subjects with platinum-resistant/refractory ovarian cancer.
Detailed description
This is an open label, dose-escalation trial to study the safety, biomarker changes (including modulation of p53), objective tumor response changes, and pharmacokinetics following administration of two different treatment regimens of Kevetrin over a 3-week period to subjects with platinum-resistant/refractory ovarian cancer. Following the 3 weeks of Kevetrin dosing, subjects are to be followed up for 3 weeks after completion of Kevetrin treatment. Standard of care treatment, as medically appropriate and per local guidelines, outside of this study protocol can commence after the collection of the post-Kevetrin treatment biomarker samples (collected on Day 21±1 day). The patient population recruited into this study includes those ovarian cancer patients that have platinum resistant/refractory disease, defined as disease progression/relapse within 6 months following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively. Patients may or may not have had additional treatment (e.g., Doxil) prior to entry in this study.
A total of approximately 10 study participants are planned to be enrolled in two cohorts of approximately 5 subjects per cohort, with enrollment in a sequential, dose-escalating fashion. Investigators and subjects will be aware of the treatment cohort into which they are recruiting. Cohort details and the planned doses are:
Cohort 1 (n=5) Kevetrin Cycle - Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses); Follow-up for 3 weeks after Kevetrin treatment ends Cohort 2 (n=5) Kevetrin Cycle - Kevetrin 350 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (1050 mg/m2 per week), for 3 weeks (single cycle; total 9 doses); Follow-up for 3 weeks after Kevetrin treatment ends Cohorts 1 and 2 will be conducted in a sequential fashion, with safety data from cohort 1 evaluated by an independent Data Monitoring Committee (DMC). The DMC will make appropriate recommendations based on the available safety data as regards the intent of progressing to the higher dose cohort 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kevetrin 250 mg/m2 IV Cohort 1 | Experimental | Drug: KevetrinKevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends |
| Kevetrin 350 mg/m2 IV Cohort 2 | Experimental | Drug: KevetrinKevetrin 350 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (1050 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Evidence of a personally signed and dated written informed consent to participate in the clinical study
- Non-pregnant female adults at least 18 years of age at time of informed consent
- Histologically confirmed serous epithelial ovarian cancer with peritoneal metastases
- Platinum resistant/refractory disease, defined as disease progression/relapse within 6 months following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively
- Measurable disease, as determined by radiologist evaluator, with at least 1 unidimensional measurable lesion (target lesion) by RECIST v.1.1 that has not previously been irradiated or biopsied
Key exclusion criteria (24 listed)
- Unwilling to allow removal of tumor biological samples for analysis, i.e., biopsies of tumor lesions, and/or collection of ascites fluid from abdominal ascites (if present)
- Non epithelial tumor, including malignant mixed Müllerian tumors without high grade serous component, or ovarian tumors with low malignant potential (i.e., borderline tumors)
- Known presence of central nervous system metastases
- Presence of tumor metastases causing significant pleural disease/effusion unilaterally or bilaterally (significant pleural effusion is defined by need for thoracentesis more frequently than once every 21 days)
- Presence of ascites that requires paracentesis more frequently than once every 21 days.
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 |
|---|---|---|
| KevetrinAlso: CohortKevetrin dose to associated cohort | Drug | Kevetrin 250 mg/m2 IV Cohort 1 |
| KevetrinKevetrin dose to associated cohort | Drug | Kevetrin 350 mg/m2 IV Cohort 2 |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events
Time frame: 6 Weeks
Reporting of Adverse Events, and severity of adverse events
Number of Participants With Changes in Biomarkers
Time frame: 3 Weeks
Changes in RNA and/or protein level of pre-specified biomarkers associated with the p53 signalling pathway and apoptosis will be compared between pre-treatment sample (tumor biopsy, ascites fluid, and peripheral blood) and post-treatment sample (tumor biopsy, ascites fluid, and peripheral blood)
4 secondary outcomes
Number of Participants by RECIST Tumor Response Category
Time frame: 3 Weeks
Maximum Plasma Concentration of Kevetrin (Cmax) on Days 1 and 5
Time frame: Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour
Time to Reach the Maximum Plasma Concentration of Kevetrin (Tmax) on Days 1 and 5
Time frame: Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUCt) on Days 1 and 5
Time frame: Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Arthur Bertolino, MD study director
Cellceutix Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kevetrin in people with Ovarian Cancer, run by Innovation Pharmaceuticals, Inc. at 2 sites 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 25 inclusion and 24 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 27 Dec 2018. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 27 Dec 2018). 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-Emergent Adverse Events (time frame: 6 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 27 Dec 2018.