TumorsPhase 1NCT00358397
One Time Injection of Bacteria to Treat Solid Tumors That Have Not Responded to Standard Therapy
A Phase 1 study testing Clostridium novyi-NT spores in people with Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This study will include a one time intravenous (IV) infusion of Clostridium novyi-NT (C. novyi-NT) spores to treat solid tumors which have not responded to standard therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors
- What is being tested?
- Clostridium novyi-NT spores
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Sep 2008
- Phase
- Phase 1
- 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 proven solid tumor malignancy as proven by referral CT scan of the chest, abdomen and pelvis.
- Patients must be refractory to standard chemotherapy or for whom no standard treatment exists. At least four weeks must have elapsed since completion of any prior chemotherapy.
- Patients must have measurable disease; defined as at least one lesion whose longest diameter can be accurately measured as >2 cm.
- ECOG performance status of 0 or 1.
- Prior locoregional therapy, including cryotherapy, radiofrequency ablation, or regional chemotherapy is allowed if at least 6 weeks have elapsed.
- Prior radiation therapy is allowed. At least 6 weeks must have elapsed since the completion of radiation therapy and the patient must have recovered from side effects.
Show all 27Show fewer
- Prior systemic radionuclide therapy is allowed. At least 4 weeks must have elapsed since completion of the therapy.
- Prior surgery is allowed. At least 6 weeks must have elapsed since the completion of major surgery and the patient must be fully recovered from this surgery and any attendant postsurgical complications.
- Patients must be 18 years of age or older
- Patients of childbearing potential must use adequate birth control measures (e.g., abstinence, barrier method with spermicide; or use by partner of oral contraceptives, intrauterine device, implantable or injectable contraceptives [i.e., Norplant or Depo-Provera] or surgical sterilization) for the duration of the study and should continue such precautions for 12 months after receiving treatment.
- Screening physical exam must be obtained less than 7 days prior to treatment and the results must meet the following criteria:
- Temperature range: < 38.0 and greater and >36.0
- Respiratory rate: 10-20 breaths per minute
- Heart rate: 50 - 85 beats per minute
- Blood pressure: Systolic blood pressure greater than 90 mm Hg and less than 155 mm Hg
- % oxygen saturation by pulse oximetry: >93%
- Screening laboratory tests will be obtained less than 7 days prior to treatment and the results must meet the following criteria:
- WBC > 3500/ mm3 and /or ANC > 1500/ mm3, and Platelet count 100,000/ mm3.
- Serum creatinine < 1.5X upper limit of normal (ULN).
- AST or ALT < 2.5X ULN, Alkaline phosphatase < 2.5X ULN, and Bilirubin < 1.5X ULN.
- INR < 1.3
- Hemoglobin > 10.0 g/dL
- Negative serum pregnancy test for females of childbearing potential.
- The patient must be capable of giving informed consent and the consent must be obtained prior to any other screening procedures that are not considered standard procedures in this patient population.
- A baseline transthoracic echocardiogram demonstrating a left ventricular ejection fraction (LVEF) greater than 50% and no significant valvular disease (Subjects with trace or mild valvular stenosis or regurgitation will be permitted to enroll in the study).
- Patient is able to stay within 45 minutes driving time of Johns Hopkins Hospital for 28 days following spore injection and the 7 day in-patient hospitalization period.
- Patient is able to stay within 45 minutes driving time of Johns Hopkins Hospital for at least 35 days after recovery from all adverse events.
Who cannot join
- Weight > 135 kg
- Chronic renal failure requiring hemodialysis or peritoneal dialysis
- Patients with renal cysts.
- Tumor lesion that is not accessible to percutaneous drainage.
- Any single contiguous lesion greater than > 12.5 cm (largest diameter).
- The sum of the largest cross-sectional diameters from any number of non-contiguous lesions > 2 cm cannot be > 25 cm.
Show all 41Show fewer
- Use of any investigational drug within 30 days prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
- Any documented evidence of primary brain malignancy or brain metastases
- Patients with any clinically significant ascites or portosystemic hypertension, chronic jaundice or cirrhosis.
- Patients with indwelling intrahepatic arterial pumps
- Patients with prosthetic joints, prosthetic valves, pacemakers or any other implanted foreign materials. (non-CNS surgical clips or staples are excluded)
- Patients with any clinically significant pleural effusions
- Patients with any evidence of hemodynamic compromise from a pericardial effusion, circumferential pericardial effusion, or any effusion greater than 1.0 cm at any location around the heart.
- Documented cirrhosis of the liver by clinical scenarios encompassing radiographic,clinical and laboratory results
- Ongoing treatment with any immunosuppressive agent(s)
- Any evidence of serious infections (such as pneumonia or pyelonephritis) or history of chronic or recurrent infectious disease in the previous 3 months.
- Less serious infections (such as acute upper respiratory tract infection(colds)or simple urinary tract infection) can be included upon the discretion of the investigator.
- Patients with opportunistic infections, including but not limited to evidence of active cytomegalovirus, Tuberculosis, active Pneumocystis carinii, Aspergillosis,histoplasmosis, or atypical mycobacterium infection, within the previous 6 months.
- Documented HIV infection.
- Active or chronic Hepatitis B or Hepatitis C.
- Presence of a transplanted solid organ (with the exception of a corneal transplant > 3 months prior to screening).
- History of an autoimmune disorder (eg, systemic lupus, pemphigus vulgaris,myasthenia gravis) ), requiring medication.
- History of Diabetes Mellitus (type I or II)
- History of rheumatic fever, endocarditis, or greater than mild valvular disease.
- Patients who depend upon COX II inhibitors or NSAIDS
- History of ongoing and active arterial vasculopathy (i.e. coronary artery disease, vasculitis, diabetic vasculopathy [i.e. retinopathy, nephropathy, etc.]) or evidence of end organ damage (visual loss, azotemia, and cutaneous ulcerations).
- History of an ischemic insult in the previous 12 months (myocardial infarction, cerebra vascular accident, ischemic tissue from injury or peripheral vascular disease)
- History of venous or lymphatic stasis resulting in venous stasis ulcers or greater than 2+ edema or lymphedema.
- History of a significant medical illness deemed by the principal investigator or sub-investigators as unsuitable for the trial - for example:
- Symptomatic congestive heart failure
- Psychiatric Illness/Social Situation that may make study dangerous
- Unstable angina pectoris
- History of a splenectomy
- Patients with a documented Penicillin or Metronidazole allergy
- Patients with a documented allergy to radiology contrast dye.
- Patient with active diverticulitis
- Patient with active dental abscesses
- Patients with inflammatory bowel disease (IBD)
- Women who are pregnant, lactating or breast feeding
- Patients with angiosarcoma
- Patients with history of a positive PPD, past TB infection or past atypical mycobacterium infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Medical Institutes
Baltimore, Maryland, 21231
About this study
Official title: Phase I Safety Study of Clostridium Novyi-NT Spores in Patients With Treatment-Refractory Solid Tumor Malignancies
This study will include a one time intravenous (IV) infusion of Clostridium novyi-NT (C. novyi-NT) spores to treat solid tumors which have not responded to standard therapy.
Read the detailed description
Investigators at the SKCCC have developed a bacterial strain (C. novyi-NT) that can infect tumors and destroy them, but does not grow in normal tissues. In animal experiments, a single intravenous injection of these bacteria can cause dramatic regression of many tumors, and the tumors do not recur in approximately (~) 30% of the animals.
This is a phase I dose escalation study using a single dose of Clostridium novyi-NT spores in patients with treatment-refractory solid tumor malignancies. The overall objective of this study is to determine the safety and document any preliminary evidence of anti-tumor activity in this patient population.
- Conditions
- Tumors
- Being tested
- Clostridium novyi-NT spores
- Keywords
- Solid Tumor, Clostridial, Spore-forming bacteria, hypoxia, anaerobes, Clostridium novyi, Bacteria, Bacteriolytic, Tumor lysis, Necrosis, Colon Cancer, Lung Cancer, Sarcoma, Bladder Cancer, Rectal Cancer, Gastric Cancer, Pancreatic Cancer, Experimental Therapy, Solid Tumors
- Medical subject headings
- Neoplasms, Hypoxia, Necrosis, Colonic Neoplasms, Lung Neoplasms, Sarcoma, Urinary Bladder Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clostridium novyi-NT sporesDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Not described Receives: Drug: Clostridium novyi-NT spores |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety profile, dose limiting toxicities (DLT), and maximum tolerated dose (MTD) of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when given as a single intravenous injection
Measured: 2 years
Secondary outcomes (3)
To document preliminary evidence of anti-tumor activity of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when given as a single intravenous injection
Measured: 2 years
To analyze the pharmacokinetics of C. novyi-NT after administration to humans with treatment-refractory solid tumor malignancies when given as a single intravenous injection
Measured: 2 years
To measure the host immune and inflammatory response to C. novyi-NT in humans with treatment-refractory solid tumor malignancies when given as a single intravenous injection
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Design Problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for TumorsStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis A Diaz, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358397
- Sponsor's protocol ID
- J0590
- Status last verified
- Oct 2016
- First submitted
- 27 Jul 2006
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Diaz LA Jr, Cheong I, Foss CA, Zhang X, Peters BA, Agrawal N, Bettegowda C, Karim B, Liu G, Khan K, Huang X, Kohli M, Dang LH, Hwang P, Vogelstein A, Garrett-Mayer E, Kobrin B, Pomper M, Zhou S, Kinzler KW, Vogelstein B, Huso DL. Pharmacologic and toxicologic evaluation of C. novyi-NT spores. Toxicol Sci. 2005 Dec;88(2):562-75. doi: 10.1093/toxsci/kfi316. Epub 2005 Sep 14.
PubMed 16162850Folkman J. A novel anti-vascular therapy for cancer. Cancer Biol Ther. 2004 Mar;3(3):338-9. doi: 10.4161/cbt.3.3.708. Epub 2004 Mar 29. No abstract available.
PubMed 14726666Dang LH, Bettegowda C, Agrawal N, Cheong I, Huso D, Frost P, Loganzo F, Greenberger L, Barkoczy J, Pettit GR, Smith AB 3rd, Gurulingappa H, Khan S, Parmigiani G, Kinzler KW, Zhou S, Vogelstein B. Targeting vascular and avascular compartments of tumors with C. novyi-NT and anti-microtubule agents. Cancer Biol Ther. 2004 Mar;3(3):326-37. doi: 10.4161/cbt.3.3.704. Epub 2004 Mar 12.
PubMed 14739784Bettegowda C, Dang LH, Abrams R, Huso DL, Dillehay L, Cheong I, Agrawal N, Borzillary S, McCaffery JM, Watson EL, Lin KS, Bunz F, Baidoo K, Pomper MG, Kinzler KW, Vogelstein B, Zhou S. Overcoming the hypoxic barrier to radiation therapy with anaerobic bacteria. Proc Natl Acad Sci U S A. 2003 Dec 9;100(25):15083-8. doi: 10.1073/pnas.2036598100. Epub 2003 Dec 1.
PubMed 14657371Dang LH, Bettegowda C, Huso DL, Kinzler KW, Vogelstein B. Combination bacteriolytic therapy for the treatment of experimental tumors. Proc Natl Acad Sci U S A. 2001 Dec 18;98(26):15155-60. doi: 10.1073/pnas.251543698. Epub 2001 Nov 27.
PubMed 11724950Agrawal N, Bettegowda C, Cheong I, Geschwind JF, Drake CG, Hipkiss EL, Tatsumi M, Dang LH, Diaz LA Jr, Pomper M, Abusedera M, Wahl RL, Kinzler KW, Zhou S, Huso DL, Vogelstein B. Bacteriolytic therapy can generate a potent immune response against experimental tumors. Proc Natl Acad Sci U S A. 2004 Oct 19;101(42):15172-7. doi: 10.1073/pnas.0406242101. Epub 2004 Oct 7.
PubMed 15471990Jain RK, Forbes NS. Can engineered bacteria help control cancer? Proc Natl Acad Sci U S A. 2001 Dec 18;98(26):14748-50. doi: 10.1073/pnas.261606598. No abstract available.
PubMed 11752416
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety Study of Clostridium Novyi-NT Spores in Patients With Treatment-Refractory Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT00358397
- Acronym / sponsor ID
- J0590
- Conditions
- Tumors
- Keywords
- Solid Tumor, Clostridial, Spore-forming bacteria, hypoxia, anaerobes, Clostridium novyi, Bacteria, Bacteriolytic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Design Problem
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 31 Jul 2006 (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 study will include a one time intravenous (IV) infusion of Clostridium novyi-NT (C. novyi-NT) spores to treat solid tumors which have not responded to standard therapy.
Detailed description
Investigators at the SKCCC have developed a bacterial strain (C. novyi-NT) that can infect tumors and destroy them, but does not grow in normal tissues. In animal experiments, a single intravenous injection of these bacteria can cause dramatic regression of many tumors, and the tumors do not recur in approximately (~) 30% of the animals.
This is a phase I dose escalation study using a single dose of Clostridium novyi-NT spores in patients with treatment-refractory solid tumor malignancies. The overall objective of this study is to determine the safety and document any preliminary evidence of anti-tumor activity in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Clostridium novyi-NT spores |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Histologically or cytologically proven solid tumor malignancy as proven by referral CT scan of the chest, abdomen and pelvis.
- Patients must be refractory to standard chemotherapy or for whom no standard treatment exists. At least four weeks must have elapsed since completion of any prior chemotherapy.
- Patients must have measurable disease; defined as at least one lesion whose longest diameter can be accurately measured as >2 cm.
- ECOG performance status of 0 or 1.
- Prior locoregional therapy, including cryotherapy, radiofrequency ablation, or regional chemotherapy is allowed if at least 6 weeks have elapsed.
Key exclusion criteria (41 listed)
- Weight > 135 kg
- Chronic renal failure requiring hemodialysis or peritoneal dialysis
- Patients with renal cysts.
- Tumor lesion that is not accessible to percutaneous drainage.
- Any single contiguous lesion greater than > 12.5 cm (largest diameter).
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 |
|---|---|---|
| Clostridium novyi-NT spores | Drug | Treatment arm |
Primary outcome
To determine the safety profile, dose limiting toxicities (DLT), and maximum tolerated dose (MTD) of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when given as a single intravenous injection
Time frame: 2 years
3 secondary outcomes
To document preliminary evidence of anti-tumor activity of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when given as a single intravenous injection
Time frame: 2 years
To analyze the pharmacokinetics of C. novyi-NT after administration to humans with treatment-refractory solid tumor malignancies when given as a single intravenous injection
Time frame: 2 years
To measure the host immune and inflammatory response to C. novyi-NT in humans with treatment-refractory solid tumor malignancies when given as a single intravenous injection
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Design Problem). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- Background: PubMed 16162850Diaz LA Jr, Cheong I, Foss CA, Zhang X, Peters BA, Agrawal N, Bettegowda C, Karim B, Liu G, Khan K, Huang X, Kohli M, Dang LH, Hwang P, Vogelstein A, Garrett-Mayer E, Kobrin B, Pomper M, Zhou S, Kinzler KW, Vogelstein B, Huso DL. Pharmacologic and toxicologic evaluation of C. novyi-NT spores. Toxicol Sci. 2005 Dec;88(2):562-75. doi: 10.1093/toxsci/kfi316. Epub 2005 Sep 14.
- Background: PubMed 14726666Folkman J. A novel anti-vascular therapy for cancer. Cancer Biol Ther. 2004 Mar;3(3):338-9. doi: 10.4161/cbt.3.3.708. Epub 2004 Mar 29. No abstract available.
- Background: PubMed 14739784Dang LH, Bettegowda C, Agrawal N, Cheong I, Huso D, Frost P, Loganzo F, Greenberger L, Barkoczy J, Pettit GR, Smith AB 3rd, Gurulingappa H, Khan S, Parmigiani G, Kinzler KW, Zhou S, Vogelstein B. Targeting vascular and avascular compartments of tumors with C. novyi-NT and anti-microtubule agents. Cancer Biol Ther. 2004 Mar;3(3):326-37. doi: 10.4161/cbt.3.3.704. Epub 2004 Mar 12.
- Background: PubMed 14657371Bettegowda C, Dang LH, Abrams R, Huso DL, Dillehay L, Cheong I, Agrawal N, Borzillary S, McCaffery JM, Watson EL, Lin KS, Bunz F, Baidoo K, Pomper MG, Kinzler KW, Vogelstein B, Zhou S. Overcoming the hypoxic barrier to radiation therapy with anaerobic bacteria. Proc Natl Acad Sci U S A. 2003 Dec 9;100(25):15083-8. doi: 10.1073/pnas.2036598100. Epub 2003 Dec 1.
- Background: PubMed 11724950Dang LH, Bettegowda C, Huso DL, Kinzler KW, Vogelstein B. Combination bacteriolytic therapy for the treatment of experimental tumors. Proc Natl Acad Sci U S A. 2001 Dec 18;98(26):15155-60. doi: 10.1073/pnas.251543698. Epub 2001 Nov 27.
- Background: PubMed 15471990Agrawal N, Bettegowda C, Cheong I, Geschwind JF, Drake CG, Hipkiss EL, Tatsumi M, Dang LH, Diaz LA Jr, Pomper M, Abusedera M, Wahl RL, Kinzler KW, Zhou S, Huso DL, Vogelstein B. Bacteriolytic therapy can generate a potent immune response against experimental tumors. Proc Natl Acad Sci U S A. 2004 Oct 19;101(42):15172-7. doi: 10.1073/pnas.0406242101. Epub 2004 Oct 7.
- Background: PubMed 11752416Jain RK, Forbes NS. Can engineered bacteria help control cancer? Proc Natl Acad Sci U S A. 2001 Dec 18;98(26):14748-50. doi: 10.1073/pnas.261606598. No abstract available.
Related trials for Tumors
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Luis A Diaz, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clostridium novyi-NT spores in people with Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site 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 27 inclusion and 41 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 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Design Problem). 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?
To determine the safety profile, dose limiting toxicities (DLT), and maximum tolerated dose (MTD) of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when given as a single intravenous injection (time frame: 2 years). 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 NCT00358397, which also lists 7 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 14 Oct 2016.