Gastric CancerPhase 3EXPANDNCT00678535
Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer
A Phase 3 study testing Cetuximab, Capecitabine and Cisplatin in people with Gastric Cancer, run by Merck KGaA, Darmstadt, Germany at 130 sites in 25 countries.
Trial summary
The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) [XP] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Cetuximab, Capecitabine and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 904 participants
- Where
- 130 sitesin 25 countries
- Study dates
- Jun 2008to Feb 2013
- Phase
- Phase 3
- 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
- Written informed consent before any study-related activities are carried out
- Age greater than or equal to (>=) 18 years
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Adenocarcinoma of the gastroesophageal junction [AEG] Types I-III according to Siewert classification)
- Archived tumor material sample for at least subsequent standardized Epidermal Growth Factor Receptor (EGFR) expression assessment
- Unresectable advanced (M0) or unresectable metastatic (M1) disease
- At least one radiographically documented measurable lesion in a previously non-irradiated area according to response evaluation criteria in solid tumors (RECIST). The primary tumor site is to be considered as a non-measurable lesion only
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- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Estimated life expectancy greater than (>) 12 weeks
- Medically accepted contraception (if the risk of conception exists)
- Glomerular filtration rate (GFR) >= 60 milliliter per minute (mL/min) The GFR is based on the Cockcroft-Gault formula for creatinine clearance
- Aspartate-aminotransferase (ASAT) less than or equal to (=<) 2.5 * upper limit of normal (ULN) and alanine-aminotransferase (ALAT) =< 2.5 *ULN
- Bilirubin =< 3 * ULN
- Absolute neutrophil count (ANC) >= 1.5 * 10^9 per liter
- Platelets >= 100 * 10^9 per liter
- Hemoglobin >=10 gram per deciliter (g/dL) (without transfusions)
- Sodium and potassium within normal limits or =< 10 percent above or below (supplementation permitted)
Who cannot join
- Prior chemotherapy, however, previous (neo-)adjuvant (radio-) chemotherapy allowed if finished > 1 year prior to start of study treatment and no more than 300 mg/m^2 cisplatin has been administered
- Prior treatment with an antibody or molecule targeting EGFR and/or Vascular Endothelial Growth Factor Receptor (VEGFR) related signaling pathways
- Brain metastasis and/or leptomeningeal disease (known or suspected)
- Radiotherapy (except localized radiotherapy for pain relief), major surgery or any investigational drug within 30 days before the start of study treatment
- Concurrent chronic systemic immune or hormone therapy not indicated in this study protocol (except for physiologic replacement)
- Clinically relevant coronary artery disease (New York Heart Association [NYHA] functional angina classification III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the 12 months before study Screening, or high risk of uncontrolled arrhythmia
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- Active Hepatitis B or C
- Chronic diarrhea or short bowel syndrome
- Presence of any contra-indication to treatment with cetuximab, capecitabine and cisplatin including:
- Known hypersensitivity to capecitabine, fluorouracil, cisplatin, cetuximab or to any of the excipients of these drugs
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Current treatment with sorivudine or chemically related analogues, such as brivudine
- Symptomatic peripheral neuropathy National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >= 2 and/or ototoxicity NCI CTCAE Grade >= 2, except if due to trauma or mechanical impairment due to tumor mass
- Pregnancy or lactation period
- Concurrent treatment with a non-permitted drug
- Treatment in another clinical study within 30 days prior to study screening
- Previous malignancy other than gastric cancer within 5 years prior to study screening, except for basal cell cancer of the skin or pre-invasive cancer of the cervix
- Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
- Legal incapacity or limited legal capacity
- Significant disease which, in the Investigator's opinion, would exclude the subject from the study
Trial locations and contacts
130 sites in 25 countries.
130 sites in 25 countries
Germany24 sites
Research Site
Berlin
Research site
Bielefeld
Research site
Braunschweig
Research site
Cologne
Research Site
Dresden
Research Site
Essen
Research site
Esslingen am Neckar
Research site
Frankfurt
Research Site
Giessen
Research Site
Hamburg
Research Site
Heidelberg
Research site
Ludwigshafen
Research Site
Mainz
Research Site
München
Research site
Offenbach
Research Site
Regensburg
Research Site
Schwäbisch Hall
Research site
Schweinfurt
Research site
Stuttgart
Research Site
Timisoara
Research Site
Troisdorf
Research site
Ulm
Research site
Weiden
Research Site
Weilheim
Japan11 sites
Research site
Chiba
Research site
Ehime
Research site
Hokkaido
Research site
Kōtoku
Research site
Nagoya
Research site
Osaka
Research site
Saitama
Research site
Shizuoka
Research site
Tochigi
Research site
Tokyo
Research site
Yokohama
Brazil7 sites
Research site
Campinas
Research site
Ijuí
Research site
Jaú
Research site
Porto Alegre
Research site
Salvador
Research site
Santo André
Research site
Sâo Paulo
Spain7 sites
Research Site
Alicante
Research site
El Palmar-Murcia
Research site
Lugo
Research site
Pamplona
Research Site
Santander
Research site
Seville
Research Site
Valencia
Taiwan7 sites
Research site
Changhua
Research site
Kaohsiung City
Research site
Kaohsiung County
Research site
Taichung
Research Site
Tainan
Research Site
Taipei
Research site
Taoyuan
China6 sites
Research site
Beijing
Research site
Guangzhou
Research site
Hefei
Research site
Nanjing
Research site
Shanghai
Research site
Shenyang
France6 sites
Research site
Besançon
Research site
Clermont-Ferrand
Research site
La Roche-sur-Yon
Research site
Marseille
Research site
Paris
Research site
Rennes
Italy6 sites
Research site
Ancona
Research site
Bologna
Research site
Milan
Research site
Naples
Research site
Roma
Research site
Rozzano (Milano)
Austria5 sites
Research site
Graz
Research site
Kufstein
Research site
Steyr
Research Site
Vienna
Research Site
Zams
Israel5 sites
Research site
Haifa
Research site
Jerusalem
Research site
Petach Tiqva
Research site
Ramat Gan
Research site
Tel Aviv
Romania5 sites
Research site
Baia Mare
Research Site
Bucharest
Research Site
Cluj-Napoca
Research Site
Iași
Research site
Timișoara
South Korea5 sites
Research site
Anyang
Research site
Daegu
Research site
Inchon-si
Research site
Seongnam
Research Site
Seoul
Bulgaria4 sites
Research site
Pleven
Research site
Plovdiv
Research site
Rousse
Research site
Sofia
Chile4 sites
Research site
Reñaca
Research site
Santiago
Research site
Temuco
Research site
Valparaíso
Hungary4 sites
Research site
Budapest
Research site
Győr
Research Site
Kaposvár
Research Site
Tatabánya
Poland4 sites
Research site
Gdansk
Research site
Lublin
Research site
Opole
Research site
Wroclaw
Russia4 sites
Research site
Kazan'
Research site
Moscow
Research site
Obninsk
Research site
Saint Petersburg
Australia3 sites
Research site
Coburg VIC
Research site
Frankston, VIC
Research site
Perth
Belgium3 sites
Research Site
Bonheiden
Research Site
Brussels
Research site
Verviers
Czechia3 sites
Research Site
Brno
Research Site
Hradec Králové
Research site
Prague
About this study
Official title: Open-label, Randomized, Controlled, Multicenter Phase III Study Investigating Cetuximab in Combination With Capecitabine (Xeloda, X) and Cisplatin (P) Versus XP Alone as First-line Treatment for Subjects With Advanced Gastric Adenocarcinoma Including Adenocarcinoma of the Gastroesophageal Junction
The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) [XP] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS).
Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.
- Conditions
- Gastric Cancer
- Being tested
- Cetuximab, Capecitabine, Cisplatin
- Keywords
- 1st line treatment for Gastric Cancer, Cetuximab, Capecitabine, Xeloda, Cisplatin, Progression-free survival
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
Single first dose of cetuximab 400 milligram per square meter (mg/m^2) will be administered intravenously over 120 minutes followed by weekly intravenous infusion of cetuximab 250 mg/m^2 over 60 minutes in each 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.
CapecitabineDrug
Also called Xeloda
Capecitabine 1000 mg/m^2 will be administered orally twice daily from evening of Day 1 to morning of Day 15 for every 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.
CisplatinDrug
Cisplatin 80 mg/m^2 will be administered intravenously with infusion over 1 to 4 hours on Day 1 of each 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab plus Capecitabine plus Cisplatin | Experimental | Not described Receives: Drug: Cetuximab; Drug: Capecitabine; Drug: Cisplatin |
| Capecitabine plus Cisplatin | Active comparator | Not described Receives: Drug: Capecitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments
The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event are censored on the date of last tumor assessment.
Measured: Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)
Secondary outcomes (5)
Overall Survival (OS)
The OS time is defined as the time from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Measured: Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)
Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments
The BOR rate is defined as the percentage of participants having achieved complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) from the IRC.
Measured: Every 6 weeks until progression, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Mean global health status and social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.
Measured: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)
Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire
EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 single items are combined to obtain a single index score that is health utility index (HUI) score reflecting subject's preferences for different health states. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QoL.
Measured: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)
Safety - Number of Participants With Adverse Events (AEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
Measured: Time from first dose up to Day 30 after last dose of study treatment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2012
- Study completionFeb 2013
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 Gastric 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 904 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Florian Lordick, MD, PhD, Principal investigator, University Clinic Leipzig, University Cancer Center Leipzig (UCCL), Leipzig Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678535
- Sponsor's protocol ID
- EMR 200048-052
- Other IDs
- 2007-004219-75
- Acronym
- EXPAND
- Status last verified
- Jul 2014
- First submitted
- 13 May 2008
- Last updated
- 21 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, Controlled, Multicenter Phase III Study Investigating Cetuximab in Combination With Capecitabine (Xeloda, X) and Cisplatin (P) Versus XP Alone as First-line Treatment for Subjects With Advanced Gastric Adenocarcinoma Including Adenocarcinoma of the Gastroesophageal Junction
- ClinicalTrials.gov ID
- NCT00678535
- Acronym / sponsor ID
- EXPAND / EMR 200048-052
- Conditions
- Gastric Cancer
- Keywords
- 1st line treatment for Gastric Cancer, Cetuximab, Capecitabine, Xeloda, Cisplatin, Progression-free survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 904 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Posted 16 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) [XP] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS).
Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cetuximab plus Capecitabine plus Cisplatin | Experimental | Drug: Cetuximab, Drug: Capecitabine, Drug: Cisplatin |
| Capecitabine plus Cisplatin | Active comparator | Drug: Capecitabine, Drug: Cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Written informed consent before any study-related activities are carried out
- Age greater than or equal to (>=) 18 years
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Adenocarcinoma of the gastroesophageal junction [AEG] Types I-III according to Siewert classification)
- Archived tumor material sample for at least subsequent standardized Epidermal Growth Factor Receptor (EGFR) expression assessment
- Unresectable advanced (M0) or unresectable metastatic (M1) disease
Key exclusion criteria (21 listed)
- Prior chemotherapy, however, previous (neo-)adjuvant (radio-) chemotherapy allowed if finished > 1 year prior to start of study treatment and no more than 300 mg/m^2 cisplatin has been administered
- Prior treatment with an antibody or molecule targeting EGFR and/or Vascular Endothelial Growth Factor Receptor (VEGFR) related signaling pathways
- Brain metastasis and/or leptomeningeal disease (known or suspected)
- Radiotherapy (except localized radiotherapy for pain relief), major surgery or any investigational drug within 30 days before the start of study treatment
- Concurrent chronic systemic immune or hormone therapy not indicated in this study protocol (except for physiologic replacement)
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 |
|---|---|---|
| CetuximabAlso: ErbituxSingle first dose of cetuximab 400 milligram per square meter (mg/m^2) will be administered intravenously over 120 minutes followed by weekly intravenous infusion of cetuximab 250 mg/m^2 over 60 minutes in each 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent. | Drug | Cetuximab plus Capecitabine plus Cisplatin |
| CapecitabineAlso: XelodaCapecitabine 1000 mg/m^2 will be administered orally twice daily from evening of Day 1 to morning of Day 15 for every 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent. | Drug | Capecitabine plus Cisplatin, Cetuximab plus Capecitabine plus Cisplatin |
| CisplatinCisplatin 80 mg/m^2 will be administered intravenously with infusion over 1 to 4 hours on Day 1 of each 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent. | Drug | Capecitabine plus Cisplatin, Cetuximab plus Capecitabine plus Cisplatin |
Primary outcome
Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments
Time frame: Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)
The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event are censored on the date of last tumor assessment.
5 secondary outcomes
Overall Survival (OS)
Time frame: Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)
Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments
Time frame: Every 6 weeks until progression, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)
Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)
Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire
Time frame: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)
Safety - Number of Participants With Adverse Events (AEs)
Time frame: Time from first dose up to Day 30 after last dose of study treatment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Florian Lordick, MD, PhD principal investigator
University Clinic Leipzig, University Cancer Center Leipzig (UCCL), Leipzig Germany
130 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cetuximab, Capecitabine and Cisplatin in people with Gastric Cancer, run by Merck KGaA, Darmstadt, Germany at 130 sites in 25 countries.
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 16 inclusion and 21 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 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 130 sites in Germany, Japan, Brazil, Spain, Taiwan and 20 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 16 May 2013). 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?
Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments (time frame: Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)). 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 21 Jul 2014.