CancerPhase 4NCT02301962
Phase IV Panitumumab Study in Indian Subjects With Metastatic Colorectal Cancer
A Phase 4 study testing Panitumumab in people with Cancer, run by Dr. Reddy's Laboratories Limited at 12 sites in India.
Trial summary
This is an open label, multicenter, non-comparative, phase IV study of panitumumab monotherapy in Indian subjects with previously treated, wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS) and wild-type Neuroblastoma rat sarcoma viral (v-ras) oncogene homolog (NRAS), metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Panitumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 12 sitesIndia
- Study dates
- 28 Jul 2015to 31 Jan 2022
- Phase
- Phase 4
- 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
- Subject or subject's legally acceptable representative has provided informed consent.
- Male or female >=18 years of age.
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum.
- Metastatic disease.
- Wild-type KRAS (without mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61], and exon 4 [codons 117 and 146]) and wild-type NRAS (without mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61], and exon 4 [codons 117 and 146]) tumor status.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Show all 14Show fewer
- Measurable or non-measurable disease per RECIST Version 1.1.
- Must have failed after fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens for metastatic disease. Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen. Metastatic relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease. Laboratory: Adequate baseline organ function defined by (<=7 days prior to first dose of study treatment).
- Hematologic function, as follows: Absolute neutrophil count (ANC) >=1.5 x 10^9/Liter (L), Platelet count >=75 x 10^9/L, Hemoglobin >=8.0 gram/deciliter (g/dL).
- Renal function, as follows: Creatinine <=1.5 x upper limit of normal (ULN).
- Hepatic function, as follows: Aspartate aminotransferase (AST) <=3 x ULN, Alanine aminotransferase (ALT) <=3 x ULN, Total Bilirubin <=1.5 x ULN.
- Metabolic function, as follows: Serum Magnesium within normal limits. Serum Calcium within normal limits. Serum Potassium within normal limits.
- All prior treatment related toxicities common terminology criteria for adverse events (CTCAE) version 4.03 <=Grade 1 at the time of enrollment.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use adequate contraception, during the study and for 2 months following the last dose of study treatment. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use adequate contraception, from time of signing informed consent until 5 months after the last dose of study treatment.
Who cannot join
- History or known presence of central nervous system metastases.
- History of another malignancy except: Malignancy treated with curative intent and with no known active disease present for >=5 years prior to enrolment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease; Adequately treated cervical carcinoma in situ without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to panitumumab or excipients that contraindicates their participation.
- Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (e.g., panitumumab or cetuximab) or treatment with small molecule EGFr inhibitors (e.g., gefitinib, erlotinib, lapatinib).
- Antitumor therapy (e.g., chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy), or investigational agent or therapy <=30 days before first dose of study treatment or not recovered from any acute toxicity.
- Other investigational procedure <=30 days before study entry.
Show all 18Show fewer
- History of interstitial lung disease (ILD) e.g., interstitial pneumonitis, pulmonary fibrosis or evidence of ILD on baseline chest computer tomography.
- Subject previously enrolled to this study.
- History of keratitis, ulcerative keratitis or severe dry eye.
- Major surgery (e.g., requiring general anesthesia) <=30 days before first dose of study treatment. Subjects must have recovered from any surgery related toxicities.
- Minor surgical procedure (e.g., open biopsy) <=7 days before first dose of study treatment, or not yet recovered from prior minor surgery Note: uncomplicated placement of vascular access device, fine needle aspiration, thoracocentesis or paracentesis >=3 days prior to first dose of study treatment is acceptable.
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <=6 months prior to enrolment.
- History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product administration, compliance with the study procedures or may interfere with the interpretation of the results.
- Unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic event <=30 days before first dose of study treatment. If on anticoagulation, subject must be on stable therapeutic dose prior to first dose of study treatment.
- Subject who is pregnant or breast feeding, or planning to become pregnant during treatment and within 2 months after the discontinuation of study treatment.
- Known positive test(s) for human immunodeficiency virus infection (testing is not required in the absence of clinical suspicion).
- Active infection requiring systemic treatment or any uncontrolled infection <=14 days prior to first dose of study treatment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection).
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures or is unwilling or unable to comply with study requirements.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
India12 sites, 11 recruiting
- Recruiting
DRL Investigational Site
Hyderabad, Telangana, 500004
Sachin Joshi, 040-48796000 ext. 6017, sachinsjoshi@drreddys.com
- Recruiting
DRL Investigational Site
Jaipur, Rajasthan, 302 020
Sachin Joshi, 040-48796000 ext. 6017, sachinsjoshi@drreddys.com
- Active, not recruiting
DRL Investigational Site
Kolkata, West Bengal, 700156
- Recruiting
DRL Investigational Site
Ludhiana, Punjab, 141010
Sachin Joshi, 040-48796000 ext. 6017, sachinsjoshi@drreddys.com
- Recruiting
DRL Investigational Site
Madurai, Tamil Nadu, 625107
Sachin Joshi, 040-48796000 ext. 6017, sachinsjoshi@drreddys.com
- Not yet recruiting
DRL Investigational Site
Mumbai, Maharashtra, 400012
Sachin Joshi, 040-48796000, sachinsjoshi@drreddys.com
- Recruiting
DRL Investigational Site
Nagpur, Maharashtra, 440026
Sachin Joshi, 040-48796000 ext. 6017, sachinsjoshi@drreddys.com
- Recruiting
DRL Investigational Site
Nashik, Maharashtra, 422004
Sachin Joshi, 040-48796000 ext. 6017, sachinsjoshi@drreddys.com
- Recruiting
DRL Investigational Site
Nashik, Maharashtra, 422005
Sachin Joshi, 040-48796000 ext. 6017, sachinsjoshi@drreddys.com
- Not yet recruiting
DRL Investigational Site
New Delhi, 110029
Sachin Joshi, 040-48796000 ext. 6017, sachinsjoshi@drreddys.com
- Recruiting
DRL Investigational Site
New Delhi, 110060
Sachin Joshi, 040-48796000 ext. 6017, sachinsjoshi@drreddys.com
- Recruiting
DRL Investigational Site
Vijayawada, Andhra Pradesh, 520002
Sachin Joshi, 040-48796000 ext. 6017, sachinsjoshi@drreddys.com
About this study
Official title: An Open Label, Multicenter, Non-Comparative, Phase IV Study of Panitumumab to Characterize Its Safety, Tolerability and Activity in Indian Subjects With Previously Treated Wild-Type RAS (KRAS and NRAS), Metastatic Colorectal Cancer
This is an open label, multicenter, non-comparative, phase IV study of panitumumab monotherapy in Indian subjects with previously treated, wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS) and wild-type Neuroblastoma rat sarcoma viral (v-ras) oncogene homolog (NRAS), metastatic colorectal cancer. This study is designed to fulfil the requirement of the Indian regulatory authority to characterize the safety and tolerability of panitumumab when administered to Indian subjects with wild-type KRAS and wild-type NRAS metastatic colorectal cancer. Approximately 58 Indian subjects with previously treated wild-type KRAS and wild-type NRAS, metastatic colorectal cancer will be enrolled in order to achieve the target enrollment of 50 evaluable subjects who have received at least one dose of panitumumab. Subjects will receive panitumumab 6 milligram/kilogram (mg/kg) intravenously every 14 days until disease progression, intolerability, withdrawal of consent, or death. All subjects will be followed at 4 weeks and 8 weeks after the last administration of panitumumab, unless the treatment was discontinued due to withdrawal of consent or death of the subject.
Read the detailed description
This is an open label, multicenter, non-comparative, phase IV study of panitumumab monotherapy in Indian subjects with previously treated, wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS) and wild-type Neuroblastoma rat sarcoma viral (v-ras) oncogene homolog (NRAS), metastatic colorectal cancer. This study is designed to fulfil the requirement of the Indian regulatory authority to characterize the safety and tolerability of panitumumab when administered to Indian subjects with wild-type KRAS and wild-type NRAS metastatic colorectal cancer. Approximately 58 Indian subjects with previously treated wild-type KRAS and wild-type NRAS, metastatic colorectal cancer will be enrolled in order to achieve the target enrollment of 50 evaluable subjects who have received at least one dose of panitumumab. Subjects will receive panitumumab 6 milligram/kilogram (mg/kg) intravenously every 14 days until disease progression, intolerability, withdrawal of consent, or death. All subjects will be followed at 4 weeks and 8 weeks after the last administration of panitumumab, unless the treatment was discontinued due to withdrawal of consent or death of the subject.
All adverse events occurring from signing of informed consent form until 8 weeks after last dose of panitumumab will be recorded. All Serious Adverse Events (SAE) considered related to panitumumab by the investigator or the sponsor will be followed until the event resolves, or is considered stable or until the subject is lost to follow-up or withdraws consent.
- Conditions
- Cancer
- Being tested
- Panitumumab
- Keywords
- panitumumab, previously treated, metastatic colorectal cancer, fully human antibody, wild-type KRAS and wild-type NRAS
- Medical subject headings
- Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanitumumabDrug
Panitumumab is available as a concentrate for solution for infusion (sterile concentrate). It is a colorless solution that may contain, translucent to white, visible amorphous, proteinaceous panitumumab particles. Each milliliter (mL) of concentrate contains 20 mg panitumumab. Each vial contains 100 mg of panitumumab in 5 mL.
| Study group | Role | What they receive |
|---|---|---|
| Panitumumab arm | Experimental | Subjects will receive panitumumab 6 mg/kg intravenously as monotherapy every 14 days until disease progression, intolerability, withdrawal of consent, or death. Receives: Drug: Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse event.
Adverse events including medically significant laboratory changes- incidence, severity, causality and outcome will be collected from the signing of informed consent form until 8 weeks following discontinuation of study treatment due to disease progression, intolerability, withdrawal of consent or death.
Measured: 8 months (average duration).
Secondary outcomes (3)
Progression free survival.
Progression free survival is defined as the interval between the treatment start date and the earliest date of disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death due to any cause.
Measured: Every 8 weeks (assessed up to average of 6 months)
Overall Response Rate.
Overall response rate is defined as the percentage of subjects with either a complete response (CR) or partial response (PR) at anytime as per RECIST version 1.1. Where CR is disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter (mm) in the short axis. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
Measured: Every 8 weeks (assessed up to average of 6 months).
Duration of response.
Duration of response is defined as the time from initial response (CR or PR) to date of disease progression per RECIST version 1.1.
Measured: Every 8 weeks (assessed up to average of 6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study start28 Jul 2015
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Dr Lalit Lakhwani, MD, Study director, Dr. Reddys Laboratories Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301962
- Sponsor's protocol ID
- DRL-INDG02-PAN/2018
- Status last verified
- Dec 2019
- First submitted
- 24 Nov 2014
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter, Non-Comparative, Phase IV Study of Panitumumab to Characterize Its Safety, Tolerability and Activity in Indian Subjects With Previously Treated Wild-Type RAS (KRAS and NRAS), Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02301962
- Acronym / sponsor ID
- DRL-INDG02-PAN/2018
- Conditions
- Cancer
- Keywords
- panitumumab, previously treated, metastatic colorectal cancer, fully human antibody, wild-type KRAS and wild-type NRAS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Amgen
- Study start
- 28 Jul 2015 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 26 Nov 2014 (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 is an open label, multicenter, non-comparative, phase IV study of panitumumab monotherapy in Indian subjects with previously treated, wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS) and wild-type Neuroblastoma rat sarcoma viral (v-ras) oncogene homolog (NRAS), metastatic colorectal cancer. This study is designed to fulfil the requirement of the Indian regulatory authority to characterize the safety and tolerability of panitumumab when administered to Indian subjects with wild-type KRAS and wild-type NRAS metastatic colorectal cancer. Approximately 58 Indian subjects with previously treated wild-type KRAS and wild-type NRAS, metastatic colorectal cancer will be enrolled in order to achieve the target enrollment of 50 evaluable subjects who have received at least one dose of panitumumab. Subjects will receive panitumumab 6 milligram/kilogram (mg/kg) intravenously every 14 days until disease progression, intolerability, withdrawal of consent, or death. All subjects will be followed at 4 weeks and 8 weeks after the last administration of panitumumab, unless the treatment was discontinued due to withdrawal of consent or death of the subject.
Detailed description
This is an open label, multicenter, non-comparative, phase IV study of panitumumab monotherapy in Indian subjects with previously treated, wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS) and wild-type Neuroblastoma rat sarcoma viral (v-ras) oncogene homolog (NRAS), metastatic colorectal cancer. This study is designed to fulfil the requirement of the Indian regulatory authority to characterize the safety and tolerability of panitumumab when administered to Indian subjects with wild-type KRAS and wild-type NRAS metastatic colorectal cancer. Approximately 58 Indian subjects with previously treated wild-type KRAS and wild-type NRAS, metastatic colorectal cancer will be enrolled in order to achieve the target enrollment of 50 evaluable subjects who have received at least one dose of panitumumab. Subjects will receive panitumumab 6 milligram/kilogram (mg/kg) intravenously every 14 days until disease progression, intolerability, withdrawal of consent, or death. All subjects will be followed at 4 weeks and 8 weeks after the last administration of panitumumab, unless the treatment was discontinued due to withdrawal of consent or death of the subject.
All adverse events occurring from signing of informed consent form until 8 weeks after last dose of panitumumab will be recorded. All Serious Adverse Events (SAE) considered related to panitumumab by the investigator or the sponsor will be followed until the event resolves, or is considered stable or until the subject is lost to follow-up or withdraws consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Panitumumab arm | Experimental | Drug: PanitumumabSubjects will receive panitumumab 6 mg/kg intravenously as monotherapy every 14 days until disease progression, intolerability, withdrawal of consent, or death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subject or subject's legally acceptable representative has provided informed consent.
- Male or female >=18 years of age.
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum.
- Metastatic disease.
- Wild-type KRAS (without mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61], and exon 4 [codons 117 and 146]) and wild-type NRAS (without mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61], and exon 4 [codons 117 and 146]) tumor status.
Key exclusion criteria (18 listed)
- History or known presence of central nervous system metastases.
- History of another malignancy except: Malignancy treated with curative intent and with no known active disease present for >=5 years prior to enrolment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease; Adequately treated cervical carcinoma in situ without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to panitumumab or excipients that contraindicates their participation.
- Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (e.g., panitumumab or cetuximab) or treatment with small molecule EGFr inhibitors (e.g., gefitinib, erlotinib, lapatinib).
- Antitumor therapy (e.g., chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy), or investigational agent or therapy <=30 days before first dose of study treatment or not recovered from any acute toxicity.
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 |
|---|---|---|
| PanitumumabPanitumumab is available as a concentrate for solution for infusion (sterile concentrate). It is a colorless solution that may contain, translucent to white, visible amorphous, proteinaceous panitumumab particles. Each milliliter (mL) of concentrate contains 20 mg panitumumab. Each vial contains 100 mg of panitumumab in 5 mL. | Drug | Panitumumab arm |
Primary outcome
Number of subjects with adverse event.
Time frame: 8 months (average duration).
Adverse events including medically significant laboratory changes- incidence, severity, causality and outcome will be collected from the signing of informed consent form until 8 weeks following discontinuation of study treatment due to disease progression, intolerability, withdrawal of consent or death.
3 secondary outcomes
Progression free survival.
Time frame: Every 8 weeks (assessed up to average of 6 months)
Overall Response Rate.
Time frame: Every 8 weeks (assessed up to average of 6 months).
Duration of response.
Time frame: Every 8 weeks (assessed up to average of 6 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
Related trials for Cancer
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.
Dr Lalit Lakhwani, MD study director
Dr. Reddys Laboratories Limited
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Panitumumab in people with Cancer, run by Dr. Reddy's Laboratories Limited at 12 sites in India.
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 14 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sachin Joshi, MPharm (040-48796000 ext. 6017, sachinsjoshi@drreddys.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse event. (time frame: 8 months (average duration).). 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 16 Dec 2019.