Carcinoid SyndromePhase 2NCT00853047
Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy
A Phase 2 study testing Telotristat etiprate and Octreotide LAR Depot in people with Carcinoid Syndrome, run by Lexicon Pharmaceuticals at 9 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of telotristat etiprate (LX1606) versus a placebo control in participants with symptomatic carcinoid syndrome not managed by stable-dose long-acting octreotide therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoid Syndrome
- What is being tested?
- Telotristat etiprate and Octreotide LAR Depot
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2009to Jun 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, aged 18 and older
- Biopsy-proven metastatic carcinoid tumor of the gastrointestinal (GI) tract with disease extent confirmed by computed tomography (CT), magnetic resonance imaging (MRI), or radionuclide imaging
- Symptoms not managed by stable-dose long-acting octreotide therapy (≥4 bowel movements per day)
- Ability to provide written informed consent
Who cannot join
- ≥12 high volume, watery bowel movements per day associated with a clinical syndrome of volume contraction, dehydration, or hypotension compatible with a "pancreatic cholera"-type clinical syndrome
- Sponsor-unacceptable clinical laboratory values for hematology and liver function tests at screening
- Karnofsky status ≤70% - unable to care for self
- Surgery within 60 days prior to screening
- A history of short bowel syndrome
- Life expectancy <12 months
Show all 9Show fewer
- History of substance or alcohol abuse within 2 years prior to screening
- Previous exposure to a tryptophan hydroxylase (TPH) inhibitor
- Administration of any investigational drug within 30 days of screening or any therapeutic protein or antibody within 90 days of screening
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
UT M.D. Anderson Cancer Center
Houston, Texas, 77030
St. Francis Medical Group Oncology and Hematology Specialists
Indianapolis, Indiana, 46237
University of Iowa
Iowa City, Iowa, 52242
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, 72205
Texas Oncology - McAllen
McAllen, Texas, 78503
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
Texas Oncology - Weslaco
Weslaco, Texas, 78596
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Ascending, Multidose Study To Determine Safety and Tolerability of Orally Administered LX1606 in Subjects With Symptomatic Carcinoid Syndrome Refractory to Stable-Dose Octreotide Long-Acting Release Depot Therapy
The purpose of this study is to evaluate the safety and tolerability of telotristat etiprate (LX1606) versus a placebo control in participants with symptomatic carcinoid syndrome not managed by stable-dose long-acting octreotide therapy. Following determination of the maximally tolerated or effective dose, cohort expansion will occur to confirm effect on symptoms and safety profile.
- Conditions
- Carcinoid Syndrome
- Being tested
- Telotristat etiprate, Octreotide LAR Depot, Placebo
- Medical subject headings
- Serotonin Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telotristat etiprateDrug
Also called LX1606
Telotristat etiprate capsules; orally 3 times daily.
Octreotide LAR DepotDrug
A stable-dose octreotide LAR depot therapy; administered subcutaneously once per month.
PlaceboDrug
Placebo-matching telotristat etiprate capsules; orally 3 times daily.
| Study group | Role | What they receive |
|---|---|---|
| Telotristat Etiprate 150 mg Core Phase | Experimental | Telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period. Receives: Drug: Telotristat etiprate; Drug: Octreotide LAR Depot |
| Telotristat Etiprate 250 mg Core Phase | Experimental | Telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period. Receives: Drug: Telotristat etiprate; Drug: Octreotide LAR Depot |
| Telotristat Etiprate 350 mg Core Phase | Experimental | Telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period. Receives: Drug: Telotristat etiprate; Drug: Octreotide LAR Depot |
| Telotristat Etiprate 500 mg Core Phase | Experimental | Telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period. Receives: Drug: Telotristat etiprate; Drug: Octreotide LAR Depot |
| Placebo Core Phase | Experimental | Placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period. Receives: Drug: Octreotide LAR Depot; Drug: Placebo |
| Telotristat Etiprate Open-Label Extension Phase | Experimental | Telotristat etiprate at assigned dose level for 8 weeks in combination with stable-dose octreotide LAR depot therapy given once per month in the open-label extension period. Upon completion of the 8-week period, participants could enter an additional extension period of 172 weeks, receiving telotristat etiprate at the assigned dose or maximum tolerated dose (500 mg 3 times daily). Receives: Drug: Telotristat etiprate; Drug: Octreotide LAR Depot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
Measured: Up to 4 Weeks Core Phase
Number of Participants With Any TEAE in the Open-Label Extension Phase
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after receiving treatment.
Measured: Up to 180 weeks in the open-label extension phase
Secondary outcomes (11)
Change From Baseline in Mean Number of Bowel Movements (BMs) Per Day
Participants recorded the number of BMs per day in a daily diary. The total number of BMs per day were averaged over the 4-week period. A negative change from Baseline indicates improvement.
Measured: Baseline to Week 4
Change From Baseline in Weekly Mean Stool Form
Participants recorded stool form in a daily diary using a 6-point scale (0-none,1-hard, 2-firm, 3-soft, 4-loose, 5-watery). A negative change from Baseline indicates improvement.
Measured: Baseline to Week 4
Change From Baseline in Percentage of Days Per Week Experiencing a Sensation of Urgency to Defecate
Participants recorded the sensation of urgency to defecate (Yes or No) in a daily diary. A negative change from Baseline indicates improvement.
Measured: Baseline to Week 4
Change From Baseline in Number of Cutaneous Flushing Episodes
Participants recorded the number of daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 4-week period. A negative change from Baseline indicates improvement.
Measured: Baseline to Week 4
Change From Baseline in Severity of Abdominal Pain or Discomfort
Participants recorded the severity of abdominal pain or discomfort in a daily diary assessed using a 4-point scale (0-none, 1-mild, 2-moderate, 3-severe). A negative change from Baseline indicates improvement.
Measured: Baseline to Week 4
Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA)
u5-HIAA is a standard test used in clinical practice to assess the neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement.
Measured: Baseline to Week 4
Change From Baseline in Chromogranin A
Blood samples were collected for assessment of Chromogranin A level. A negative change from Baseline indicates improvement.
Measured: Baseline to Week 4
Number of Participants Reporting Improvement in the Subjective Global Assessment of Symptoms Associated With Carcinoid Syndrome
Participants were asked to answer the following question: "In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain, or discomfort?". The number of participants who answered Yes are reported.
Measured: Week 4
Change From Baseline in Frequency of Rescue for Short-acting Octreotide Use/Day
Participants recorded details (location and frequency of injection) of subcutaneous injections of rescue, short-acting octreotide, if taken, in the daily diary. A negative change from Baseline indicates improvement.
Measured: Baseline to Week 4
Time to First Rescue, Short-acting Octreotide
Time to the first subcutaneous injections of rescue, short-acting octreotide was determined from the participant's daily diary.
Measured: Baseline to Week 4
Number of Participants Experiencing Complete Response at Week 4
Complete Response to treatment was defined as one of the following: 1. Less than 4 bowel movements per day; or 2. A decrease in daily bowel movements that is ≥ 50% from baseline; or 3. A positive response to the global assessment question ("In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain or discomfort?") for each of the last 2 weeks of the Treatment Period.
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2014
- Study completionJun 2014
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 (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoid SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pablo Lapuerta, MD, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853047
- Sponsor's protocol ID
- LX1606.1-202-CS
- Other IDs
- LX1606.202
- Status last verified
- Oct 2018
- First submitted
- 25 Feb 2009
- Last updated
- 26 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gelhorn HL, Kulke MH, O'Dorisio T, Yang QM, Jackson J, Jackson S, Boehm KA, Law L, Kostelec J, Auguste P, Lapuerta P. Patient-reported Symptom Experiences in Patients With Carcinoid Syndrome After Participation in a Study of Telotristat Etiprate: A Qualitative Interview Approach. Clin Ther. 2016 Apr;38(4):759-68. doi: 10.1016/j.clinthera.2016.03.002. Epub 2016 Mar 31.
PubMed 27041406Kulke MH, O'Dorisio T, Phan A, Bergsland E, Law L, Banks P, Freiman J, Frazier K, Jackson J, Yao JC, Kvols L, Lapuerta P, Zambrowicz B, Fleming D, Sands A. Telotristat etiprate, a novel serotonin synthesis inhibitor, in patients with carcinoid syndrome and diarrhea not adequately controlled by octreotide. Endocr Relat Cancer. 2014 Oct;21(5):705-14. doi: 10.1530/ERC-14-0173. Epub 2014 Jul 10.
PubMed 25012985
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Ascending, Multidose Study To Determine Safety and Tolerability of Orally Administered LX1606 in Subjects With Symptomatic Carcinoid Syndrome Refractory to Stable-Dose Octreotide Long-Acting Release Depot Therapy
- ClinicalTrials.gov ID
- NCT00853047
- Acronym / sponsor ID
- LX1606.1-202-CS
- Conditions
- Carcinoid Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Posted 26 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of telotristat etiprate (LX1606) versus a placebo control in participants with symptomatic carcinoid syndrome not managed by stable-dose long-acting octreotide therapy. Following determination of the maximally tolerated or effective dose, cohort expansion will occur to confirm effect on symptoms and safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Telotristat Etiprate 150 mg Core Phase | Experimental | Drug: Telotristat etiprate, Drug: Octreotide LAR DepotTelotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period. |
| Telotristat Etiprate 250 mg Core Phase | Experimental | Drug: Telotristat etiprate, Drug: Octreotide LAR DepotTelotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period. |
| Telotristat Etiprate 350 mg Core Phase | Experimental | Drug: Telotristat etiprate, Drug: Octreotide LAR DepotTelotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period. |
| Telotristat Etiprate 500 mg Core Phase | Experimental | Drug: Telotristat etiprate, Drug: Octreotide LAR DepotTelotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period. |
| Placebo Core Phase | Experimental | Drug: Octreotide LAR Depot, Drug: PlaceboPlacebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period. |
| Telotristat Etiprate Open-Label Extension Phase | Experimental | Drug: Telotristat etiprate, Drug: Octreotide LAR DepotTelotristat etiprate at assigned dose level for 8 weeks in combination with stable-dose octreotide LAR depot therapy given once per month in the open-label extension period. Upon completion of the 8-week period, participants could enter an additional extension period of 172 weeks, receiving telotristat etiprate at the assigned dose or maximum tolerated dose (500 mg 3 times daily). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females, aged 18 and older
- Biopsy-proven metastatic carcinoid tumor of the gastrointestinal (GI) tract with disease extent confirmed by computed tomography (CT), magnetic resonance imaging (MRI), or radionuclide imaging
- Symptoms not managed by stable-dose long-acting octreotide therapy (≥4 bowel movements per day)
- Ability to provide written informed consent
Key exclusion criteria (9 listed)
- ≥12 high volume, watery bowel movements per day associated with a clinical syndrome of volume contraction, dehydration, or hypotension compatible with a "pancreatic cholera"-type clinical syndrome
- Sponsor-unacceptable clinical laboratory values for hematology and liver function tests at screening
- Karnofsky status ≤70% - unable to care for self
- Surgery within 60 days prior to screening
- A history of short bowel syndrome
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 |
|---|---|---|
| Telotristat etiprateAlso: LX1606Telotristat etiprate capsules; orally 3 times daily. | Drug | Telotristat Etiprate 150 mg Core Phase, Telotristat Etiprate 250 mg Core Phase, Telotristat Etiprate 350 mg Core Phase, Telotristat Etiprate 500 mg Core Phase, Telotristat Etiprate Open-Label Extension Phase |
| Octreotide LAR DepotA stable-dose octreotide LAR depot therapy; administered subcutaneously once per month. | Drug | Placebo Core Phase, Telotristat Etiprate 150 mg Core Phase, Telotristat Etiprate 250 mg Core Phase, Telotristat Etiprate 350 mg Core Phase, Telotristat Etiprate 500 mg Core Phase, Telotristat Etiprate Open-Label Extension Phase |
| PlaceboPlacebo-matching telotristat etiprate capsules; orally 3 times daily. | Drug | Placebo Core Phase |
Primary outcome
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase
Time frame: Up to 4 Weeks Core Phase
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
Number of Participants With Any TEAE in the Open-Label Extension Phase
Time frame: Up to 180 weeks in the open-label extension phase
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after receiving treatment.
11 secondary outcomes
Change From Baseline in Mean Number of Bowel Movements (BMs) Per Day
Time frame: Baseline to Week 4
Change From Baseline in Weekly Mean Stool Form
Time frame: Baseline to Week 4
Change From Baseline in Percentage of Days Per Week Experiencing a Sensation of Urgency to Defecate
Time frame: Baseline to Week 4
Change From Baseline in Number of Cutaneous Flushing Episodes
Time frame: Baseline to Week 4
Change From Baseline in Severity of Abdominal Pain or Discomfort
Time frame: Baseline to Week 4
Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA)
Time frame: Baseline to Week 4
Change From Baseline in Chromogranin A
Time frame: Baseline to Week 4
Number of Participants Reporting Improvement in the Subjective Global Assessment of Symptoms Associated With Carcinoid Syndrome
Time frame: Week 4
Change From Baseline in Frequency of Rescue for Short-acting Octreotide Use/Day
Time frame: Baseline to Week 4
Time to First Rescue, Short-acting Octreotide
Time frame: Baseline to Week 4
Number of Participants Experiencing Complete Response at Week 4
Time frame: Baseline to Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27041406Gelhorn HL, Kulke MH, O'Dorisio T, Yang QM, Jackson J, Jackson S, Boehm KA, Law L, Kostelec J, Auguste P, Lapuerta P. Patient-reported Symptom Experiences in Patients With Carcinoid Syndrome After Participation in a Study of Telotristat Etiprate: A Qualitative Interview Approach. Clin Ther. 2016 Apr;38(4):759-68. doi: 10.1016/j.clinthera.2016.03.002. Epub 2016 Mar 31.
- Derived from this study: PubMed 25012985Kulke MH, O'Dorisio T, Phan A, Bergsland E, Law L, Banks P, Freiman J, Frazier K, Jackson J, Yao JC, Kvols L, Lapuerta P, Zambrowicz B, Fleming D, Sands A. Telotristat etiprate, a novel serotonin synthesis inhibitor, in patients with carcinoid syndrome and diarrhea not adequately controlled by octreotide. Endocr Relat Cancer. 2014 Oct;21(5):705-14. doi: 10.1530/ERC-14-0173. Epub 2014 Jul 10.
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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.
Pablo Lapuerta, MD study director
Lexicon Pharmaceuticals, Inc.
9 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 Telotristat etiprate and Octreotide LAR Depot in people with Carcinoid Syndrome, run by Lexicon Pharmaceuticals at 9 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 4 inclusion and 9 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 26 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 9 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 26 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 Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase (time frame: Up to 4 Weeks Core Phase). 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 NCT00853047, which also lists 2 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 26 Dec 2018.