Adenocarcinoma of the ColonPhase 2NCT01270438
Combination Chemotherapy and Bevacizumab With or Without RO4929097 in Treating Patients With Metastatic Colorectal Cancer
A Phase 2 study testing FOLFOX regimen, gamma-secretase/Notch signalling pathway inhibitor RO4929097 and bevacizumab in people with Adenocarcinoma of the Colon and Adenocarcinoma of the Rectum, run by National Cancer Institute (NCI) at 3 sites in United States.
Trial summary
This phase II clinical trial is studying how well giving combination chemotherapy and bevacizumab with or without RO4929097 works in treating patients with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer
- What is being tested?
- FOLFOX regimen, gamma-secretase/Notch signalling pathway inhibitor RO4929097 and bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2010to Aug 2013
- Phase
- Phase 2
- 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
- Histologically or cytologically confirmed adenocarcinoma of the colon or adenocarcinoma of the rectum
- Metastatic disease by imaging
- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20mm by conventional techniques or as ≥ 10 mm by spiral CT scan
- No known brain metastases
- ECOG performance status 0-1
- ANC ≥ 1,500/mm³
Show all 57Show fewer
- WBC ≥ 3,000/mm³
- Platelet count ≥ 100,000/mm³ (without a platelet transfusion ≤ 14 days prior to study)
- Hemoglobin ≥ 9 g/dL
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- Urine protein:creatinine ≤ 0.5 or proteinuria < 1,000 mg on 24-hour urine collection
- Total bilirubin ≤ 1.5 times ULN
- AST and ALT ≤ 2.5 times ULN (≤ 5.0 times ULN for patients with liver metastases)
- Albumin ≥ 2.5 g/dL
- Amylase ≤ 2 times ULN
- Lipase ≤ 2 times ULN
- PTT ≤ 1.2 times ULN
- INR ≤ 1.2 times ULN
- No patients with uncontrolled hypophosphatemia, hypocalcemia, hypomagnesemia, hyponatremia, or hypokalemia defined as less than the lower limit of normal for the institution, despite adequateelectrolyte supplementation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use two forms of contraception (i.e., barrier contraception and one other method of contraception) prior to, during, and for ≥ 12 months after study participation
- Patients must not have current evidence of or history of another malignancy except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other curatively treated solid tumors with no evidence of disease for ≥ 3 years prior to enrollment
- Able to swallow capsules
- No malabsorption syndrome or other condition that would interfere with intestinal absorption
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to gamma-secretase inhibitor RO4929097 used in the study
- No clinically important history of liver disease, including known viral, other hepatitis, or cirrhosis
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- A history of torsades de pointes or other significant cardiac arrhythmias
- Psychiatric illness and/or social situations that would limit compliance with study requirements
- No baseline QTcF > 450 msec (male) or QTcF > 470msec (female)
- No serious or non-healing wound, ulcer, or bone fracture
- No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No significant traumatic injury within the past 28 days
- No clinically significant cardiovascular disease, including any of the following:
- Inadequately controlled hypertension (systolic BP > 160 mm Hg and/or diastolic BP > 90 mm Hg despite antihypertension medication)
- History of cerebrovascular accident within the past 6 months
- Myocardial infarction or unstable angina within the past 6 months
- NYHA grade II-IV congestive heart failure
- Serious and inadequately controlled cardiac arrhythmia
- No requirement for antiarrhythmics or other medications known to prolong QTc
- No significant vascular disease (e.g., aortic aneurysm, requiring surgical repair, history of aortic dissection, or recent peripheral arterial thrombosis) within the past 6 months
- No clinically significant peripheral vascular disease
- No evidence of bleeding diathesis or coagulopathy
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- Recovered to < NCI CTCAE grade 2 toxicities related to prior therapy
- No prior adjuvant or neoadjuvant chemotherapy for colorectal cancers within 12 months of development of metastases
- No prior chemotherapy or gamma-secretase inhibitors or other investigational agents for metastatic colorectal cancer
- No prior radiotherapy for colorectal cancers including in the neoadjuvant or adjuvant setting within 12 months of development of metastases
- No major surgical procedure or open biopsy within the past 28 days and no anticipation of need for major surgical procedures during the course of the study
- No concurrent medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin®)
- Patients who switch from warfarin sodium to alternative anti-coagulant agents allowed
- No concurrent medications that are strong inducers, inhibitors, or substrates of CYP3A4, including ketoconazole and grapefruit juice
- No concurrent combination antiretroviral therapy for HIV-positive patients
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Phase 2 Study of RO4929097 (NSC 749225) in Combination With FOLFOX Plus Bevacizumab Versus FOLFOX Plus Bevacizumab Alone for the First-Line Treatment of Patients With Metastatic Colorectal Cancer (NCI #8467)
This phase II clinical trial is studying how well giving combination chemotherapy and bevacizumab with or without RO4929097 works in treating patients with metastatic colorectal cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy and bevacizumab is more effective with RO4929097 in treating patients with colorectal cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate the efficacy, as determined by progression-free survival, of FOLFOX6 and bevacizumab with versus without gamma-secretase inhibitor RO4929097 (RO4929097).
SECONDARY OBJECTIVES:
- To estimate the clinical benefit of RO4929097 in combination with mFOLFOX6 and bevacizumab, as measured by objective response rate.
II. To evaluate the safety and tolerability of RO4929097 in combination with mFOLFOX6 chemotherapy and bevacizumab.
III. To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of RO4929097 in combination with mFOLFOX6 and bevacizumab.
IV. To investigate PD response of RO4929097 in combination with mFOLFOX6 chemotherapy and bevacizumab, as assessed by direct measurement of gamma-secretase enzyme activity, in tumor samples.
- (Exploratory) To investigate the Notch signaling pathway genes targeted by RO4929097 in combination with mFOLFOX6 chemotherapy and bevacizumab and correlate with clinical outcome.
VI. (Exploratory) To investigate the Ras signaling pathway genes targeted by RO4929097 in combination with mFOLFOX6 chemotherapy and bevacizumab and correlate with clinical outcome.
VII. (Exploratory) To investigate putative colorectal cancer stem cells targeted by RO4929097 in combination with mFOLFOX6 chemotherapy and bevacizumab and correlate with clinical outcome.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center, prior therapy (adjuvant/neoadjuvant vs none), and number of organs* involved by metastases (1 vs > 1). Patients are randomized to 1 of 2 treatment arms.
NOTE: *Lesions all in the liver would be considered as 1 organ involved.
ARM I: Patients receive FOLFOX6 regimen comprising oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46 hours, and bevacizumab IV over 30-90 minutes on days 1-2. Patients also receive oral gamma-secretase inhibitor RO4929097 on days 1-3 and 8-10.
Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity (RO4929097 is given for up to 12 courses).
ARM II: Patients receive FOLFOX6 regimen and bevacizumab as in arm I.
Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients may undergo blood sample collection at baseline and periodically during study for pharmacokinetic, pharmacodynamic, and correlative studies.
After completion of study therapy, patients are followed up for 12 months.
- Conditions
- Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer
- Being tested
- FOLFOX regimen, gamma-secretase/Notch signalling pathway inhibitor RO4929097, bevacizumab, oxaliplatin, leucovorin calcium
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX regimenDrug
Given IV
gamma-secretase/Notch signalling pathway inhibitor RO4929097Drug
Given orally
bevacizumabBiological
Given IV
oxaliplatinDrug
Given IV
Given IV
fluorouracilDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (RO4929097, combination chemotherapy, bevacizumab) | Experimental | Patients receive FOLFOX6 regimen comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46 hours, and bevacizumab IV over 30-90 minutes on days 1-2. Patients also receive oral gamma-secretase inhibitor RO4929097 on days 1-3 and 8-10. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: FOLFOX regimen; Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097; Biological: bevacizumab; Drug: oxaliplatin; Drug: leucovorin calcium; Drug: fluorouracil |
| Arm II (combination chemotherapy, bevacizumab) | Experimental | Patients receive FOLFOX6 regimen and bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: FOLFOX regimen; Biological: bevacizumab; Drug: oxaliplatin; Drug: leucovorin calcium; Drug: fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival of patients treated with FOLFOX6 plus bevacizumab with or without gamma-secretase inhibitor RO4929097
Progression is defined as changes in RECIST 1.1-defined imaging, progression in non-target lesions as defined by RECIST 1.1, unequivocal clinical deterioration, or death from any cause.
Measured: From start of treatment to time of progression, assessed up to 12 months
Secondary outcomes (3)
Objective response rate (complete or partial response) as measured by RECIST
Estimated using the binomial distribution and exact 95% confidence intervals (CI) will be provided.
Measured: Assessed up to 12 months
Incidence of dose-limiting and non-dose-limiting toxicities
Summarized using descriptive statistics.
Measured: Assessed up to 12 months
Pharmacokinetics and pharmacodynamics of gamma-secretase inhibitor RO4929097
Computed using non- compartmental methods for RO4929097 and will be correlated with clinical parameters using Cox regression model for association with survival and PFS and Wilcoxon rank sum test for response.
Measured: Baseline, and day 1 of courses 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionAug 2011
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ColonStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Neil Segal, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270438
- Sponsor's protocol ID
- NCI-2011-02571
- Other IDs
- NCI-2011-02571, CDR0000692198, MSKCC-10191, 10-191, 8467, U01CA069856, N01CM62206
- Status last verified
- Apr 2017
- First submitted
- 4 Jan 2011
- Last updated
- 4 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of RO4929097 (NSC 749225) in Combination With FOLFOX Plus Bevacizumab Versus FOLFOX Plus Bevacizumab Alone for the First-Line Treatment of Patients With Metastatic Colorectal Cancer (NCI #8467)
- ClinicalTrials.gov ID
- NCT01270438
- Acronym / sponsor ID
- NCI-2011-02571
- Conditions
- Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2010 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 5 Jan 2011 (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.
This phase II clinical trial is studying how well giving combination chemotherapy and bevacizumab with or without RO4929097 works in treating patients with metastatic colorectal cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy and bevacizumab is more effective with RO4929097 in treating patients with colorectal cancer.
Detailed description
PRIMARY OBJECTIVES:
- To estimate the efficacy, as determined by progression-free survival, of FOLFOX6 and bevacizumab with versus without gamma-secretase inhibitor RO4929097 (RO4929097).
SECONDARY OBJECTIVES:
- To estimate the clinical benefit of RO4929097 in combination with mFOLFOX6 and bevacizumab, as measured by objective response rate.
II. To evaluate the safety and tolerability of RO4929097 in combination with mFOLFOX6 chemotherapy and bevacizumab.
III. To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of RO4929097 in combination with mFOLFOX6 and bevacizumab.
IV. To investigate PD response of RO4929097 in combination with mFOLFOX6 chemotherapy and bevacizumab, as assessed by direct measurement of gamma-secretase enzyme activity, in tumor samples.
- (Exploratory) To investigate the Notch signaling pathway genes targeted by RO4929097 in combination with mFOLFOX6 chemotherapy and bevacizumab and correlate with clinical outcome.
VI. (Exploratory) To investigate the Ras signaling pathway genes targeted by RO4929097 in combination with mFOLFOX6 chemotherapy and bevacizumab and correlate with clinical outcome.
VII. (Exploratory) To investigate putative colorectal cancer stem cells targeted by RO4929097 in combination with mFOLFOX6 chemotherapy and bevacizumab and correlate with clinical outcome.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center, prior therapy (adjuvant/neoadjuvant vs none), and number of organs* involved by metastases (1 vs > 1). Patients are randomized to 1 of 2 treatment arms.
NOTE: *Lesions all in the liver would be considered as 1 organ involved.
ARM I: Patients receive FOLFOX6 regimen comprising oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46 hours, and bevacizumab IV over 30-90 minutes on days 1-2. Patients also receive oral gamma-secretase inhibitor RO4929097 on days 1-3 and 8-10.
Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity (RO4929097 is given for up to 12 courses).
ARM II: Patients receive FOLFOX6 regimen and bevacizumab as in arm I.
Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients may undergo blood sample collection at baseline and periodically during study for pharmacokinetic, pharmacodynamic, and correlative studies.
After completion of study therapy, patients are followed up for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (RO4929097, combination chemotherapy, bevacizumab) | Experimental | Drug: FOLFOX regimen, Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097, Biological: bevacizumab, Drug: oxaliplatin, Drug: leucovorin calcium, Drug: fluorouracilPatients receive FOLFOX6 regimen comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46 hours, and bevacizumab IV over 30-90 minutes on days 1-2. Patients also receive oral gamma-secretase inhibitor RO4929097 on days 1-3 and 8-10. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. |
| Arm II (combination chemotherapy, bevacizumab) | Experimental | Drug: FOLFOX regimen, Biological: bevacizumab, Drug: oxaliplatin, Drug: leucovorin calcium, Drug: fluorouracilPatients receive FOLFOX6 regimen and bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (57 listed)
- Histologically or cytologically confirmed adenocarcinoma of the colon or adenocarcinoma of the rectum
- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20mm by conventional techniques or as ≥ 10 mm by spiral CT scan
- No known brain metastases
- ECOG performance status 0-1
- ANC ≥ 1,500/mm³
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| FOLFOX regimenGiven IV | Drug | Arm I (RO4929097, combination chemotherapy, bevacizumab), Arm II (combination chemotherapy, bevacizumab) |
| gamma-secretase/Notch signalling pathway inhibitor RO4929097Given orally | Drug | Arm I (RO4929097, combination chemotherapy, bevacizumab) |
| bevacizumabGiven IV | Biological | Arm I (RO4929097, combination chemotherapy, bevacizumab), Arm II (combination chemotherapy, bevacizumab) |
| oxaliplatinGiven IV | Drug | Arm I (RO4929097, combination chemotherapy, bevacizumab), Arm II (combination chemotherapy, bevacizumab) |
| leucovorin calciumGiven IV | Drug | Arm I (RO4929097, combination chemotherapy, bevacizumab), Arm II (combination chemotherapy, bevacizumab) |
| fluorouracilGiven IV | Drug | Arm I (RO4929097, combination chemotherapy, bevacizumab), Arm II (combination chemotherapy, bevacizumab) |
Primary outcome
Progression-free survival of patients treated with FOLFOX6 plus bevacizumab with or without gamma-secretase inhibitor RO4929097
Time frame: From start of treatment to time of progression, assessed up to 12 months
Progression is defined as changes in RECIST 1.1-defined imaging, progression in non-target lesions as defined by RECIST 1.1, unequivocal clinical deterioration, or death from any cause.
3 secondary outcomes
Objective response rate (complete or partial response) as measured by RECIST
Time frame: Assessed up to 12 months
Incidence of dose-limiting and non-dose-limiting toxicities
Time frame: Assessed up to 12 months
Pharmacokinetics and pharmacodynamics of gamma-secretase inhibitor RO4929097
Time frame: Baseline, and day 1 of courses 1 and 2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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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.
Neil Segal principal investigator
Memorial Sloan Kettering Cancer Center
3 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 FOLFOX regimen, gamma-secretase/Notch signalling pathway inhibitor RO4929097 and bevacizumab in people with Adenocarcinoma of the Colon and Adenocarcinoma of the Rectum, run by National Cancer Institute (NCI) at 3 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 57 inclusion and 0 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: withdrawn, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Progression-free survival of patients treated with FOLFOX6 plus bevacizumab with or without gamma-secretase inhibitor RO4929097 (time frame: From start of treatment to time of progression, assessed up to 12 months). 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 4 Apr 2017.