NeoplasmsPhase 2NCT00448136
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Endocrine Tumors of the Gastrointestinal Tract.
A Phase 2 study testing bevacizumab [Avastin], 5 FU and Streptozotocin in people with Neoplasms, run by Hoffmann-La Roche at 27 sites in France.
Trial summary
This 2 arm study will assess the efficacy and safety of two systemic treatments including Avastin in patients with previously-untreated progressive locally advanced/metastatic well-differentiated digestive endocrine tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- bevacizumab [Avastin], 5 FU and Streptozotocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 27 sitesFrance
- Study dates
- Jul 2007to Nov 2011
- 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
- adult patients, >=18 years of age;
- well-differentiated gastrointestinal tract endocrine tumors, or duodeno-pancreatic endocrine tumors;
- no previous anti-cancer therapy, other than surgery;
- progressive metastatic disease;
- >=1 measurable lesion.
Who cannot join
- abnormal cardiac function, with history of ischemic heart disease in past 6 months and/or abnormal 12 lead ECG;
- patients with known bleeding disorders;
- unstable systemic disease;
- chronic daily treatment with high-dose aspirin, NSAIDs or corticosteroids;
- previous history of malignancy (other than successfully treated basal and squamous cell cancer of the skin, and/or in situ cancer of the cervix).
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
France27 sites
Study site
Angers, 49933
Study site
Bordeaux, 33075
Study site
Boulogne-Billancourt, 92104
Study site
Caen, 14033
Study site
Chambray-lès-Tours, 37171
Study site
Clichy, 92118
Study site
Créteil, 94010
Study site
Dijon, 21079
Study site
Lille, 59020
Study site
Lyon, 69437
Study site
Marseille, 13273
Study site
Marseille, 13285
Study site
Marseille, 13385
Study site
Montpellier, 34298
Study site
Nantes, 44093
Study site
Nice, 06189
Study site
Paris, 75571
Study site
Paris, 75651
Study site
Paris, 75908
Study site
Paris, 75970
Study site
Poitiers, 86021
Study site
Reims, 51092
Study site
Rouen, 76031
Study site
Saint-Brieuc, 22015
Study site
Strasbourg, 67091
Study site
Toulouse, 31059
Study site
Villejuif, 94805
About this study
Official title: An Open Label Study to Evaluate the Effect of Avastin in Association With Chemotherapy on Progression-free Survival in Patients With Progressive Advanced/Metastatic Well-differentiated Digestive Endocrine Tumors of the Gastrointestinal Tract
This 2 arm study will assess the efficacy and safety of two systemic treatments including Avastin in patients with previously-untreated progressive locally advanced/metastatic well-differentiated digestive endocrine tumors. Patients with duodeno-pancreatic tumors (arm 1) will be treated with 5FU/streptozotocin iv (5FU 400mg/m2/d D1 to D5;streptozotocin 500mg/m2/d/iv D1 to D5;D1=D42) every 6 weeks, plus Avastin 7.5mg/kg iv every 3 weeks. Patients with gastrointestinal tract tumors (arm 2) will be treated with Xeloda 1000mg/m2 po bid D1 to D14 plus Avastin 7.5mg/kg iv D1=D21 every 3 weeks. The patients will be treated with chemotherapy for a minimum of 6 months, unless there is tumor progression and/or unacceptable toxicity. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is <100 individuals.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumab [Avastin]Drug
7.5mg/kg iv on day 1 every 3 weeks
5 FUDrug
400mg/m2/day iv on days 1-5 every 6 weeks
StreptozotocinDrug
500mg/m2/day iv on days 1-5 every 6 weeks
XelodaDrug
1000mg/m2 po bid on days 1-14 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: bevacizumab [Avastin]; Drug: 5 FU; Drug: Streptozotocin |
| 2 | Experimental | Not described Receives: Drug: bevacizumab [Avastin]; Drug: Xeloda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) - Percentage of Participants With an Event
PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.
Measured: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
PFS - Time to Event
PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression. Median PFS was estimated using the Kaplan-Meier method.
Measured: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
PFS - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months
PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.
Measured: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Secondary outcomes (13)
Percentage of Participants With a Response by Best Overall Response
Best overall response defined as best response recorded during the study as defined according to RECIST; performed by the investigator and by centralized review. Complete response (CR): complete disappearance of all target lesions and non-target disease. All lesions, both target and non-target, must have decreased to normal (short axis, less than [<]10 millimeters [mm]). No new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter (LD) was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD): not qualifying for CR, PR, or Progressive Disease (PD). PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
Measured: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Duration of Overall Response (OR) - Percentage of Participants With an Event
Determined only for those participants with an overall response (CR or PR) and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
Measured: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Duration of OR - Time to Event
Determined only for those participants with an overall response (CR or PR) and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression. Median duration of OR was estimated using the Kaplan-Meier method.
Measured: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Duration of OR - Percentage of Participants With Sustained Response at 12 and 24 Months
Duration of OR was determined only for those participants with an overall response of CR or PR and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
Measured: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Duration of Overall Disease Control (ODC) - Percentage of Participants With an Event
Determined only for those participants with overall disease control (CR, PR or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
Measured: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Duration of ODC - Time to Event
Determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression. Median time to event was estimated using the Kaplan-Meier method.
Measured: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Duration of ODC - Percentage of Participants Maintaining Disease Control at 12 and 24 Months
Duration of ODC was determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR, or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
Measured: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Overall Survival (OS) - Percentage of Participants With an Event
OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit.
Measured: Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
OS - Time to Event
OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit. Median OS was estimated using the Kaplan-Meier method.
Measured: Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
OS - Percentage of Participants Surviving at 12 and 24 Months
OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit.
Measured: Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
Global Health Status as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
Measured: Screening, every 3 months during treatment
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Changes from baseline were categorized as follows: Very much worsening (less than [<]-20); Moderate worsening (greater than or equal to [≥]-20 to <-10); Little worsening (≥-10 to <-5); No change (≥-5 to less than or equal to [≤]5); Little improvement (>5 to ≤10); Moderate improvement (>10 to ≤20); and Very much improved (>20).
Measured: Screening, every 3 months during treatment
EORTC QLQ-C30 Functional and Symptom Scale Scores
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scale scores a higher level represents a more severe level of symptoms.
Measured: Screening, every 3 months during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2007 (estimated)
- Study startJul 2007
- Primary completionNov 2011
- Study completionNov 2011
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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448136
- Sponsor's protocol ID
- ML20383
- Status last verified
- Jan 2015
- First submitted
- 15 Mar 2007
- Last updated
- 22 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Evaluate the Effect of Avastin in Association With Chemotherapy on Progression-free Survival in Patients With Progressive Advanced/Metastatic Well-differentiated Digestive Endocrine Tumors of the Gastrointestinal Tract
- ClinicalTrials.gov ID
- NCT00448136
- Acronym / sponsor ID
- ML20383
- Conditions
- Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 Mar 2007 (estimated)
- Results
- Posted 22 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 2 arm study will assess the efficacy and safety of two systemic treatments including Avastin in patients with previously-untreated progressive locally advanced/metastatic well-differentiated digestive endocrine tumors. Patients with duodeno-pancreatic tumors (arm 1) will be treated with 5FU/streptozotocin iv (5FU 400mg/m2/d D1 to D5;streptozotocin 500mg/m2/d/iv D1 to D5;D1=D42) every 6 weeks, plus Avastin 7.5mg/kg iv every 3 weeks. Patients with gastrointestinal tract tumors (arm 2) will be treated with Xeloda 1000mg/m2 po bid D1 to D14 plus Avastin 7.5mg/kg iv D1=D21 every 3 weeks. The patients will be treated with chemotherapy for a minimum of 6 months, unless there is tumor progression and/or unacceptable toxicity. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is <100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bevacizumab [Avastin], Drug: 5 FU, Drug: Streptozotocin |
| 2 | Experimental | Drug: bevacizumab [Avastin], Drug: Xeloda |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patients, >=18 years of age;
- well-differentiated gastrointestinal tract endocrine tumors, or duodeno-pancreatic endocrine tumors;
- no previous anti-cancer therapy, other than surgery;
- progressive metastatic disease;
- >=1 measurable lesion.
Key exclusion criteria (5 listed)
- abnormal cardiac function, with history of ischemic heart disease in past 6 months and/or abnormal 12 lead ECG;
- patients with known bleeding disorders;
- unstable systemic disease;
- chronic daily treatment with high-dose aspirin, NSAIDs or corticosteroids;
- previous history of malignancy (other than successfully treated basal and squamous cell cancer of the skin, and/or in situ cancer of the cervix).
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 |
|---|---|---|
| bevacizumab [Avastin]7.5mg/kg iv on day 1 every 3 weeks | Drug | 1, 2 |
| 5 FU400mg/m2/day iv on days 1-5 every 6 weeks | Drug | 1 |
| Streptozotocin500mg/m2/day iv on days 1-5 every 6 weeks | Drug | 1 |
| Xeloda1000mg/m2 po bid on days 1-14 every 3 weeks | Drug | 2 |
Primary outcome
Progression-Free Survival (PFS) - Percentage of Participants With an Event
Time frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.
PFS - Time to Event
Time frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression. Median PFS was estimated using the Kaplan-Meier method.
PFS - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months
Time frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.
13 secondary outcomes
Percentage of Participants With a Response by Best Overall Response
Time frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Duration of Overall Response (OR) - Percentage of Participants With an Event
Time frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Duration of OR - Time to Event
Time frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Duration of OR - Percentage of Participants With Sustained Response at 12 and 24 Months
Time frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Duration of Overall Disease Control (ODC) - Percentage of Participants With an Event
Time frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Duration of ODC - Time to Event
Time frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Duration of ODC - Percentage of Participants Maintaining Disease Control at 12 and 24 Months
Time frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Overall Survival (OS) - Percentage of Participants With an Event
Time frame: Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
OS - Time to Event
Time frame: Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
OS - Percentage of Participants Surviving at 12 and 24 Months
Time frame: Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
Global Health Status as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
Time frame: Screening, every 3 months during treatment
Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
Time frame: Screening, every 3 months during treatment
EORTC QLQ-C30 Functional and Symptom Scale Scores
Time frame: Screening, every 3 months during treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
- 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.
Clinical Trials study director
Hoffmann-La Roche
27 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 bevacizumab [Avastin], 5 FU and Streptozotocin in people with Neoplasms, run by Hoffmann-La Roche at 27 sites in France.
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 5 inclusion and 5 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 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France. 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 22 Jan 2015). 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) - Percentage of Participants With an Event (time frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years). The study lists 3 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 22 Jan 2015.