Non-Small Cell Lung CancerPhase 3NCT00460317
MONET1-MOtesanib NSCLC Efficacy and Tolerability Study
A Phase 3 study testing AMG 706, paclitaxel and carboplatin in people with Non-Small Cell Lung Cancer, run by Amgen.
Trial summary
To determine if treatment with AMG 706 (motesanib diphosphate) in combination with paclitaxel and carboplatin improves overall survival compared to treatment with placebo in combination with paclitaxel and carboplatin in subjects with advanced non-squamous NSCLC and in subjects with adenocarcinoma histology… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- AMG 706, paclitaxel and carboplatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,450 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Aug 2013
- Phase
- Phase 3
- 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 confirmed, unresectable stage 111B with pericardial or pleural effusion or stage IV or recurrent non squamous NSCLC.
- Measurable or non-measurable disease per modified RECIST criteria
- ECOG performance status of 0 or 1
- Life expectancy of greater than or equal to 3 months as documented by the investigator
- ability to take oral medications
- competency to give written informed consent
Show all 19Show fewer
- able to start protocol directed therapy within 7 days from date of randomization
- Hematological function, as follows:
- Absolute neutrophil count (ANC) > = 1.5 x 109/L
- Platelet count > = 100 x 109/L and < = 850 x 109/L
- Hemoglobin > =9 g/dL
- Renal function, as follows:
- Creatinine clearance > 40 mL/min (calculated by Cockcroft Gault formula)
- Urinary protein quantitative value of < = 30 mg in urinalysis or < = 1+ on dipstick unless quantitative protein is < 500 mg in a 24 hour urine sample
- Hepatic function, as follows:
- Aspartate aminotransferase (AST) < =2.5 x upper limit of normal (ULN) OR AST < 5 x ULN if liver metastases are present
- Alanine aminotransferase (ALT) < =2.5 x ULN OR ALT < 5 x ULN if liver metastases are present
- Alkaline phosphatase < = 2.0 x ULN OR alkaline phosphatase < 5 x ULN if liver or bone metastases are present
- Total bilirubin < 1.5 x ULN OR total bilirubin < 3 X ULN if subject has UGT1A1 promoter polymorphism (ie, Gilbert syndrome) confirmed by genotyping or Invader UGT1A1 Molecular Assay prior to randomization Partial thromboplastin (PTT) or activated partial thromboplastin time (aPTT) < = 1 x ULN and international normalized ratio (INR) < = 1.5 x ULN
Who cannot join
- Subjects with adenosquamous histology or an unclear histology subtype (eg, not otherwise specified) containing greater than 10% squamous cells
- untreated or symptomatic central nervous system metastases. Subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastases, and the subject is clinically stable and is off corticosteroids for at least 2 weeks prior to randomization.
- Prior chemotherapy as follows: Any prior chemotherapy for advanced non squamous NSCLC
- Any prior adjuvant chemotherapy for non squamous NSCLC within 52 weeks prior to randomization. Adjuvant chemotherapy completed > 52 weeks prior to randomization is permitted. Any prior chemoradiation for locally advanced stage III disease.
- Prior (within 30 days of randomization) yellow fever vaccination.
- Central (chest) radiation therapy within 28 days prior to randomization, radiation therapy within 14 days prior to randomization for peripheral lesions.
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- History of pulmonary hemorrhage or gross hemoptysis (approximately 3 mL of bright red blood or more) within 6 months prior to randomization.
- Prior targeted therapies, including but not limited to:
- AMG 706, inhibitors of VEGF (eg, SU5416, SU6668, ZD6474, SU11248, PTK787, AZD2171, AEE 788, sorafenib, bevacizumab), or EGFr (eg, panitumumab, cetuximab, gefitinib, erlotinib).
- Known history of allergy or hypersensitivity reaction to paclitaxel or carboplatin.
- Any anticoagulation therapy within 7 days prior to randomization. The use of low-dose warfarin [ < = 2 mg daily] or low molecular weight heparin or heparin flushes for prophylaxis against central venous catheter thrombosis is allowed.
- History of arterial or venous thrombosis within 12 months prior to randomization.
- History of bleeding diathesis or bleeding within 14 days prior to randomization.
- Peripheral neuropathy > grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
- Clinically significant cardiac disease within 12 months of randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent, congestive heart failure, or ongoing arrhythmias requiring medication.
- History of other primary cancer unless: Curatively resected non melanomatous skin cancer. Curatively treated cervical carcinoma in situ. Other primary solid tumor curatively treated with no known active disease present and no curative treatment administered for the last 3 years
- Any kind of disorder that compromises the ability of the subject to comply with the study procedures.
- Open wound, ulcer or fracture.
- Uncontrolled hypertension as defined by resting blood pressure > 150/90 mm Hg. Antihypertensive medications are allowed if the subject is stable on their current dose at the time of randomization.
- Surgery:
- Major surgical procedures within 28 days prior to randomization
- Minor surgical procedures within 14 days prior to randomization
- Failure to recover from prior surgery
- Placement of a central venous access device (including ports and tunneled or non-tunneled catheters) within 7 days prior to randomization
- Planned elective surgery while on study treatment
- Core needle biopsy within 7 days prior to randomization
- Not recovered from all previous therapies (ie, radiation, surgery and medications). Adverse events related to previous therapies must be CTCAE grade < = 1 at screening or returned to the subject's baseline prior to their most recent previous therapy.
- Participation in therapeutic clinical trials or currently receiving other investigational treatment(s) within 30 days prior to randomization.
- Pregnant (eg, positive HCG test-serum or urine) or breast feeding woman.
- Any subject not consenting to use adequate contraceptive precautions (eg, hormonal, barrier or abstinence) during the course of the study and for 6 months after the last treatment.
- Known to be human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C positive.
- Known chronic hepatitis.
- Active infection requiring systemic treatment or any uncontrolled infection < = 14 days prior to randomization.
- History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results.
- Previously randomized to this study.
- Not available for follow-up assessments or unable to comply with study requirements.
About this study
Official title: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial of AMG 706 in Combination With Paclitaxel and Carboplatin for Advanced Non-small Cell Lung Cancer.
To determine if treatment with AMG 706 (motesanib diphosphate) in combination with paclitaxel and carboplatin improves overall survival compared to treatment with placebo in combination with paclitaxel and carboplatin in subjects with advanced non-squamous NSCLC and in subjects with adenocarcinoma histology (adenocarcinoma subpopulation).
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- AMG 706, placebo, paclitaxel, carboplatin
- Keywords
- lung, cancer, chemotherapy, paclitaxel, carboplatin, placebo, angiogenesis, VEGF, multi kinase inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 706Drug
125 mg QD orally every day
placeboDrug
125 mg QD orally every day
paclitaxelDrug
200mg/m2 on day 1 of each 3 week cycle +/- 3 days for a max of 6 cycles
carboplatinDrug
AUC of 600mg/mL x min by Calvert formula on day 1 of each 3 week cycle +/- 3 days for a max of 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Arm B | Placebo comparator | All subjects on this treatment arm will receive a standard paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200mg/m2 and carboplatin at AUC of 6mg/mL x min by Calvert formula) on day 1 of each 3 week cycle + - 3 days for a maximum of 6 cycles and placebo 125mg QD orally Receives: Drug: placebo; Drug: paclitaxel; Drug: carboplatin |
| Arm A | Active comparator | All subjects on this treatment arm will receive a standard paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200mg/m2 and carboplatin at AUC of 6mg/mL x min by Calvert formula) on day 1 of each 3 week cycle + - 3 days for a maximum of 6 cycles and AMG 706 125mg QD orally. Receives: Drug: AMG 706; Drug: paclitaxel; Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival time. Time from randomization to death. Subjects who have not died while on study or are lost to follow up will be censored at their last contact date.
Measured: Not able to be measured
Secondary outcomes (8)
Duration of response (calculated for only those subjects who respond)
Measured: Time from first objective tumour response to objective disease progression or death due to any cause.
Pharmacokinetics of AMG 706 when administered in combination with paclitaxel and carboplatin.
Measured: Throughout the duration the patient is in the study.
Association of AMG 706 treatment-induced PlGF increase with OS in subjects with non-squamous NSCLC and in subjects with adenocarcinoma histology
Measured: Overall survival time in the PlGF analysis set
Evaluation of OS, PFS, AMG 706 treatment-induced PlGF increase association with OS, ORR (only in subjects with measurable disease) and duration of response in subjects with non-squamous, non-adenocarcinoma histology
Measured: OS, ORR and duration of response in the PlGF analysis set
Evaluation of the pharmacokinetics of AMG 706 and metabolites when administered with paclitaxel and carboplatin (in approximately 250 subjects at selected centers)
Measured: Carboplatin PK samples drawn from subjects at Cycle 3 and Cycle 5
Safety and tolerability of AMG 706 in combination with paclitaxel and carboplatin compared to placebo in combination with paclitaxel and carboplatin in subjects with non-squamous NSCLC histology and in subjects with adenocarcinoma histology.
Measured: Throughout the duration the patient is in the study
Progression free survival time: Subjects who have not progressed or died on study will be censored at their last evaluable assessment date.
Measured: Time from randomization to objective disease progression or death due to any cause
Objective tumour response rate (complete and partial response) according to modified RECIST criteria in subjects with measurable disease at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2011
- Study completionAug 2013
Why it stopped: Amgen discontinued the development of AMG706 because 20050201 did not meet its primary objective.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,450 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460317
- Sponsor's protocol ID
- 20050201
- Status last verified
- Aug 2015
- First submitted
- 12 Apr 2007
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Scagliotti GV, Vynnychenko I, Park K, Ichinose Y, Kubota K, Blackhall F, Pirker R, Galiulin R, Ciuleanu TE, Sydorenko O, Dediu M, Papai-Szekely Z, Banaclocha NM, McCoy S, Yao B, Hei YJ, Galimi F, Spigel DR. International, randomized, placebo-controlled, double-blind phase III study of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous non-small-cell lung cancer: MONET1. J Clin Oncol. 2012 Aug 10;30(23):2829-36. doi: 10.1200/JCO.2011.41.4987. Epub 2012 Jul 2.
PubMed 22753922Bass MB, Yao B, Hei YJ, Ye Y, Davis GJ, Davis MT, Kaesdorf BA, Chan SS, Patterson SD. Challenges in developing a validated biomarker for angiogenesis inhibitors: the motesanib experience. PLoS One. 2014 Oct 14;9(10):e108048. doi: 10.1371/journal.pone.0108048. eCollection 2014.
PubMed 25314641Novello S, Scagliotti GV, Sydorenko O, Vynnychenko I, Volovat C, Schneider CP, Blackhall F, McCoy S, Hei YJ, Spigel DR. Motesanib plus carboplatin/paclitaxel in patients with advanced squamous non-small-cell lung cancer: results from the randomized controlled MONET1 study. J Thorac Oncol. 2014 Aug;9(8):1154-61. doi: 10.1097/JTO.0000000000000227.
PubMed 25157768Kubota K, Ichinose Y, Scagliotti G, Spigel D, Kim JH, Shinkai T, Takeda K, Kim SW, Hsia TC, Li RK, Tiangco BJ, Yau S, Lim WT, Yao B, Hei YJ, Park K. Phase III study (MONET1) of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous nonsmall-cell lung cancer (NSCLC): Asian subgroup analysis. Ann Oncol. 2014 Feb;25(2):529-36. doi: 10.1093/annonc/mdt552. Epub 2014 Jan 13.
PubMed 24419239
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial of AMG 706 in Combination With Paclitaxel and Carboplatin for Advanced Non-small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT00460317
- Acronym / sponsor ID
- 20050201
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- lung, cancer, chemotherapy, paclitaxel, carboplatin, placebo, angiogenesis, VEGF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Amgen discontinued the development of AMG706 because 20050201 did not meet its primary objective.
- Enrolment
- 1,450 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Takeda
- Study start
- Jul 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 Apr 2007 (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.
To determine if treatment with AMG 706 (motesanib diphosphate) in combination with paclitaxel and carboplatin improves overall survival compared to treatment with placebo in combination with paclitaxel and carboplatin in subjects with advanced non-squamous NSCLC and in subjects with adenocarcinoma histology (adenocarcinoma subpopulation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm B | Placebo comparator | Drug: placebo, Drug: paclitaxel, Drug: carboplatinAll subjects on this treatment arm will receive a standard paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200mg/m2 and carboplatin at AUC of 6mg/mL x min by Calvert formula) on day 1 of each 3 week cycle + - 3 days for a maximum of 6 cycles and placebo 125mg QD orally |
| Arm A | Active comparator | Drug: AMG 706, Drug: paclitaxel, Drug: carboplatinAll subjects on this treatment arm will receive a standard paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200mg/m2 and carboplatin at AUC of 6mg/mL x min by Calvert formula) on day 1 of each 3 week cycle + - 3 days for a maximum of 6 cycles and AMG 706 125mg QD orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically confirmed, unresectable stage 111B with pericardial or pleural effusion or stage IV or recurrent non squamous NSCLC.
- Measurable or non-measurable disease per modified RECIST criteria
- ECOG performance status of 0 or 1
- Life expectancy of greater than or equal to 3 months as documented by the investigator
- ability to take oral medications
Key exclusion criteria (36 listed)
- Subjects with adenosquamous histology or an unclear histology subtype (eg, not otherwise specified) containing greater than 10% squamous cells
- untreated or symptomatic central nervous system metastases. Subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastases, and the subject is clinically stable and is off corticosteroids for at least 2 weeks prior to randomization.
- Prior chemotherapy as follows: Any prior chemotherapy for advanced non squamous NSCLC
- Any prior adjuvant chemotherapy for non squamous NSCLC within 52 weeks prior to randomization. Adjuvant chemotherapy completed > 52 weeks prior to randomization is permitted. Any prior chemoradiation for locally advanced stage III disease.
- Prior (within 30 days of randomization) yellow fever vaccination.
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 |
|---|---|---|
| AMG 706125 mg QD orally every day | Drug | Arm A |
| placebo125 mg QD orally every day | Drug | Arm B |
| paclitaxel200mg/m2 on day 1 of each 3 week cycle +/- 3 days for a max of 6 cycles | Drug | Arm A, Arm B |
| carboplatinAUC of 600mg/mL x min by Calvert formula on day 1 of each 3 week cycle +/- 3 days for a max of 6 cycles | Drug | Arm A, Arm B |
Primary outcome
Overall survival time. Time from randomization to death. Subjects who have not died while on study or are lost to follow up will be censored at their last contact date.
Time frame: Not able to be measured
8 secondary outcomes
Duration of response (calculated for only those subjects who respond)
Time frame: Time from first objective tumour response to objective disease progression or death due to any cause.
Pharmacokinetics of AMG 706 when administered in combination with paclitaxel and carboplatin.
Time frame: Throughout the duration the patient is in the study.
Association of AMG 706 treatment-induced PlGF increase with OS in subjects with non-squamous NSCLC and in subjects with adenocarcinoma histology
Time frame: Overall survival time in the PlGF analysis set
Evaluation of OS, PFS, AMG 706 treatment-induced PlGF increase association with OS, ORR (only in subjects with measurable disease) and duration of response in subjects with non-squamous, non-adenocarcinoma histology
Time frame: OS, ORR and duration of response in the PlGF analysis set
Evaluation of the pharmacokinetics of AMG 706 and metabolites when administered with paclitaxel and carboplatin (in approximately 250 subjects at selected centers)
Time frame: Carboplatin PK samples drawn from subjects at Cycle 3 and Cycle 5
Safety and tolerability of AMG 706 in combination with paclitaxel and carboplatin compared to placebo in combination with paclitaxel and carboplatin in subjects with non-squamous NSCLC histology and in subjects with adenocarcinoma histology.
Time frame: Throughout the duration the patient is in the study
Progression free survival time: Subjects who have not progressed or died on study will be censored at their last evaluable assessment date.
Time frame: Time from randomization to objective disease progression or death due to any cause
Objective tumour response rate (complete and partial response) according to modified RECIST criteria in subjects with measurable disease at baseline.
Results and safety
The study was stopped early (reason given: Amgen discontinued the development of AMG706 because 20050201 did not meet its primary objective.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Background: PubMed 22753922Scagliotti GV, Vynnychenko I, Park K, Ichinose Y, Kubota K, Blackhall F, Pirker R, Galiulin R, Ciuleanu TE, Sydorenko O, Dediu M, Papai-Szekely Z, Banaclocha NM, McCoy S, Yao B, Hei YJ, Galimi F, Spigel DR. International, randomized, placebo-controlled, double-blind phase III study of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous non-small-cell lung cancer: MONET1. J Clin Oncol. 2012 Aug 10;30(23):2829-36. doi: 10.1200/JCO.2011.41.4987. Epub 2012 Jul 2.
- Background: PubMed 25314641Bass MB, Yao B, Hei YJ, Ye Y, Davis GJ, Davis MT, Kaesdorf BA, Chan SS, Patterson SD. Challenges in developing a validated biomarker for angiogenesis inhibitors: the motesanib experience. PLoS One. 2014 Oct 14;9(10):e108048. doi: 10.1371/journal.pone.0108048. eCollection 2014.
- Background: PubMed 25157768Novello S, Scagliotti GV, Sydorenko O, Vynnychenko I, Volovat C, Schneider CP, Blackhall F, McCoy S, Hei YJ, Spigel DR. Motesanib plus carboplatin/paclitaxel in patients with advanced squamous non-small-cell lung cancer: results from the randomized controlled MONET1 study. J Thorac Oncol. 2014 Aug;9(8):1154-61. doi: 10.1097/JTO.0000000000000227.
- Derived from this study: PubMed 24419239Kubota K, Ichinose Y, Scagliotti G, Spigel D, Kim JH, Shinkai T, Takeda K, Kim SW, Hsia TC, Li RK, Tiangco BJ, Yau S, Lim WT, Yao B, Hei YJ, Park K. Phase III study (MONET1) of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous nonsmall-cell lung cancer (NSCLC): Asian subgroup analysis. Ann Oncol. 2014 Feb;25(2):529-36. doi: 10.1093/annonc/mdt552. Epub 2014 Jan 13.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AMG 706, paclitaxel and carboplatin in people with Non-Small Cell Lung Cancer, run by Amgen.
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 19 inclusion and 36 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: stopped early, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Amgen discontinued the development of AMG706 because 20050201 did not meet its primary objective.). Results are not available in the source record.
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?
Overall survival time. Time from randomization to death. Subjects who have not died while on study or are lost to follow up will be censored at their last contact date. (time frame: Not able to be measured). 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 NCT00460317, which also lists 4 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 7 Sep 2015.