HNSCCPhase 1TAPISNCT02216617
Evaluation of the Tolerance of Afatinib in Combination With Docetaxel and Cisplatin in LAHNSCC Induction Chemotherapy
A Phase 1 study testing Taxotere, Cisplatin, Afatinib in people with HNSCC, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.
Trial summary
The purpose of the study is to determine the maximum tolerated dose (MTD) of afatinib administrated in combination with docetaxel (Taxotere®) and cisplatin in induction chemotherapy of locally advanced head and neck carcinoma in order to move to a phase II, allowing the comparison with standard induction chemotherapy… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HNSCC
- What is being tested?
- Taxotere, Cisplatin, Afatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 6 Aug 2014to 15 Sep 2015
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤70 years
- Patient in first line treatment of Locally Advanced HNSCC, histologically proven non-metastatic
- At least one measurable lesion (RECIST)
- Eligible patient for standard induction chemotherapy in the opinion of the investigator; PS ECOG < 2
- Adequacy functioning of organs, including:
- Left ventricular function with ejection fraction at rest > 50% or as normal institutional values Haematological function
Show all 14Show fewer
- Absolute neutrophil count (ANC) >1,500/mm3 Special cases: ANC> 1,000/mm3 in the opinion of the investigator and discussion with the sponsor; Platelets ≥ 75,000/mm3; Hemoglobin> 10g/dl
- Liver function:
- •Total bilirubin ≤ 1.5 x ULN; patients with Gilbert's syndrome must have a total bilirubin <4 x ULN; SGOT and SGPT ≤ 3 x ULN or SGOT and SGPT ≤ 5 x ULN in case liver abnormalities; Alkaline phosphatase <2.5 x ULN
- Kidney function:
- •Serum creatinine <110 umol/L or creatinine clearance > 45 ml/min (Cockcroft method)
- General:
- Men and women of childbearing potential must agree to use a reliable contraception throughout treatment and at least 6 months after the end of treatment. Women in peri-menopause should be least 24 months of amenorrhea.
- Ability to take oral medication in the opinion of the investigator; Patient affiliated to a social security system; signed informed consent form.
Who cannot join
- •Previous treatment with chemotherapy, radiation therapy or targeted therapy for head and neck cancer; uncontrolled Respiratory, cardiac, hepatic or renal diseases.
- Significant cardiovascular disease like:
- Cardiovascular Abnormalities considered clinically important as congestive heart failure NYHA stage ≥ III, unstable angina or myocardial infarction within the past 6 months, or arrhythmia low controlled, uncontrolled hypertension by treatment (systolic BP ≥ 160 mmHg and/or diastolic BP≥ 90 mmHg).
- Impairment of left ventricular function with an ejection fraction ≤ 50%; Stroke within 6 months prior to inclusion.
- Severe thromboembolic history within 6 months prior to inclusion.
- Lengthening of the corrected QT interval with QTc> 480 msec according to the formula Bazet; Bradycardia; Electrolyte disturbances
Show all 20Show fewer
- Respiratory disease of type:
- •interstitial lung disease; Pulmonary fibrosis
- Viral disease of type:
- •Active infection or hepatic B virus or hepatitis C known carrier of HIV.
- Recent digestive disorder with diarrhea such as:
- Any history or presence of gastrointestinal disorders with uncontrolled diarrhea as a major symptom that may affect the absorption of drug tested in the opinion of the investigator (eg disease Crohn's disease, diarrhea CTCAE grade ≥ 2)
- Any past or present condition that would compromise the patient's ability to comply with the study or which would interfere with the evaluation of the effectiveness and the safety of the study.
- Other severe disease or condition associated with non-oncological origin likely to be incompatible with the protocol in the judgment of the investigator.
- Patient already included in another clinical trial with an experimental molecule; Persons deprived of liberty or under guardianship or as backup justice.
- Patient requiring prohibited concomitant treatments with study.
- Any cons-indication to treatment with Taxotere or Afatinib or cisplatin.
- Known hypersensitivity to Afatinib or excipients the study drugs; Major surgery within 4 weeks before taking treatment; Use of products in a clinical study during the 4 weeks preceding inclusion.
- Radiation therapy within 4 weeks before inclusion.
- •Presence and / or history (in the past 3 years) cancer except Basal cell skin cancer, cervical carcinoma in situ and prostate cancer in situ; Pregnant or during breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study Evaluating the Combination Afatinib With Docetaxel and Cisplatin (TPA) in Induction Chemotherapy in Locally Advanced Squamous Cell Carcinoma of the Upper Aerodigestive Tract
The purpose of the study is to determine the maximum tolerated dose (MTD) of afatinib administrated in combination with docetaxel (Taxotere®) and cisplatin in induction chemotherapy of locally advanced head and neck carcinoma in order to move to a phase II, allowing the comparison with standard induction chemotherapy TPF.
It is a multicentric, national, opened, not-randomized phase Ib. Three doses of afatinib (20, 30 and 40 Mg per day) will be studied in combination with the fixed standard doses of docetaxel and cisplatin. For each dose level, beginning with smallest (20 Mg per day of afatinib), 3 to 6 patients will be treated at maximum, i.e. 3 cycles of three weeks treatment each one (9 weeks on the whole). The next dose level will be studied only if the previous dose is well tolerated for the period of the first 4 weeks observation of the treatment (1st cycle more first week of the 2nd cycle). Once the MTD is determined, four additional patients will be treated with this dose. A maximum of 22 patients should be included in this study. The total duration of the study is estimated at 18 months. In case of major safety problems, the study may be stopped earlier. In short, the preclinical data, pharmacological and clinical on afatinib indicate that the benefit-risk ratio can be regarded as positive and that the association of afatinib with cisplatin and docetaxel could be effective in patients with head and neck squamous cell carcinoma potentially resulting in an extension of time to progression.
Read the detailed description
Cancers of the upper aerodigestive tract correspond in the Western countries about 5% of cancers. They are treated by surgery, radiotherapy, and chemotherapy. Although progress in radio chemotherapy have reduced mortality and increase the rates of organ preservation in patients with locally advanced head and neck cancers, they have metastatic risk or particularly high local recurrence. The induction chemotherapy is a first-line treatment of cancer in which the patient receives doses of chemotherapy allowing to obtain a significant reduction in tumor size, and thus to avoid the surgery and to treat the tumor then by radiotherapy alone or combine by certain drugs. The standard treatment of induction chemotherapy currently used for the carcinoma of aerodigestive tract is TPF compose of 3 drugs: the docetaxel (or Taxotere®, T), the cisplatin (P) and the 5-fluorouracil (or 5FU, F). Despite of the relative efficacy of this treatment, which provides a survival benefit, it is necessary to find a combination of induction to be more effective and less toxic. That is why this study intended to check if a new combination called TPA in which the fluorouracil (F) is replaced by the afatinib (A), will be more beneficial. The afatinib is a powerful and irreversible inhibitor of the EGFR (human Epidermal Growth Factor Receptor type 1), HER2 and HER 4. The EGFR is associated with a pejorative prognosis and resistance to the treatments through its role in the proliferation (multiplication of tumoral cells), the cell survival and replication and angiogenesis (process of growth of new blood-vessels, vital in the growth of the malignant tumors). Afatinib has proved effective in patients in with local recurrence or metastatic squamous cell carcinoma of the head and neck after first line cisplatin based and tolerance is correct.
The rational of this study is based on the following elements:
- Cisplatin and docetaxel on the one hand and the afatinib on the other hand have proved effectiveness in head and neck cancers. The tolerance of their association is not known.
- In addition, several broad randomized trials have shown that it is possible to improve the effectiveness of induction chemotherapy in locally advanced head and neck carcinoma by the addition of Taxotere® to the cisplatin-5FU.
- Independently, it has been shown in carcinoma of the upper aerodigestive tract with recurrence or metastatic, that an anti-EGFR targeted therapy by cetuximab could improve the effectiveness of chemotherapy with cisplatin-5FU More recently, Taxotere® and Cisplatin + Cetuximab (or Erbitux®) combination for the treatment of head and neck squamous cell carcinoma has been tested in a broad study of phase II showing the good feasibility of this combination and a particularly high rate of tumoral response.
- Finally a comparative study of cetuximab versus afatinib showed an advantage in terms of tumoral response in support of afatinib.
From all these observations, the investigators can hypothesize that the addition of afatinib to the docetaxel and the cisplatin could be an induction treatment for locally advanced carcinoma both innovating and promising. Indeed, this regimen appears optimized in terms of efficiency, incorporating both the combination of the most active cytotoxic agents, Taxotere® and the cisplatin, but also potentially more effective than Erbitux®.
The purpose of the study is to determine the Maximum Tolerated Dose (MTD) of afatinib administrated in combination with docetaxel (Taxotere®) and cisplatin in induction chemotherapy of locally advanced head and neck carcinoma in order to move to a phase II, allowing the comparison with standard induction chemotherapy TPF.
It is a multicentric, national, opened, not-randomized phase Ib. Three doses of the afatinib (20, 30 and 40 Mg per day) will be studied in combination with the fixed standard doses of the docetaxel and the cisplatin. For each dose level, beginning with smallest (20 Mg per day of afatinib), 3 to 6 patients will be treated at maximum, i.e. 3 cycles of three weeks treatment each one (9 weeks on the whole). The next dose level will be studied only if the previous dose is well tolerated for the period of the first 4 weeks observation of the treatment (1st cycle and first week of the 2nd cycle). Once the MTD is determine, four additional patients will be treated with this dose. A maximum of 22 patients should be included in this study. The total duration of the study is estimated at 18 months. In case of major safety problems, the study may be stopped earlier. In short, the preclinical data, pharmacological and clinical on afatinib indicate that the benefit-risk ratio can be regarded as positive and that the association of afatinib with cisplatin and docetaxel could be effective in patients with head and neck squamous cell carcinoma potentially resulting in an extension of time to progression.
- Conditions
- HNSCC
- Being tested
- Taxotere, Cisplatin, Afatinib
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taxotere, Cisplatin, AfatinibDrug
| Study group | Role | What they receive |
|---|---|---|
| Induction chemotherapy TPA | Experimental | 3 Cycles of induction chemotherapy TPA : (Taxotere, Cisplatin, Afatinib)
1 cycle = 3 weeks, three cycles of treatment in total (or 9 weeks)
Docetaxel 75 mg / m2 at D1 Cisplatin 75 mg / m 2 at D1 Afatinib: x mg / day D2 to D21 by level: (Level 1: 20 mg / day; Level 2: 30 mg / day; Level 3: 40 mg / day) Receives: Drug: Taxotere, Cisplatin, Afatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
The main objective is to determine the Maximum Tolerated Dose (MTD) of afatinib in combination with docetaxel and cisplatin chemotherapy TPA induction in locally advanced head and neck carcinomas in order to move a phase II for comparison with induction chemotherapy "of reference "TPF (Taxotere, cisplatin and 5-fluorouracil).
Measured: During the first 4 weeks of treatment for each patient of the bearing.
Secondary outcomes (2)
Tolerance
Tolerance: Toxicity will be evaluated by NCI CTCAE V4.03. scale
Measured: 12 weeks
Efficacy
Efficacy: Objective tumor response will be evaluated through RECIST V1.1
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study start6 Aug 2014
- Primary completionJul 2015
- Study completion15 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et Cou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier CUPISSOL, MD, Study chair, GORTEC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216617
- Sponsor's protocol ID
- GORTEC 2013-01
- Other IDs
- 2013-002876-42
- Acronym
- TAPIS
- Status last verified
- Oct 2017
- First submitted
- 7 Aug 2014
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Evaluating the Combination Afatinib With Docetaxel and Cisplatin (TPA) in Induction Chemotherapy in Locally Advanced Squamous Cell Carcinoma of the Upper Aerodigestive Tract
- ClinicalTrials.gov ID
- NCT02216617
- Acronym / sponsor ID
- TAPIS / GORTEC 2013-01
- Conditions
- HNSCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et CouUniversity, hospital or other
- Study start
- 6 Aug 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- 15 Sep 2015 (actual)
- First posted
- 15 Aug 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.
The purpose of the study is to determine the maximum tolerated dose (MTD) of afatinib administrated in combination with docetaxel (Taxotere®) and cisplatin in induction chemotherapy of locally advanced head and neck carcinoma in order to move to a phase II, allowing the comparison with standard induction chemotherapy TPF.
It is a multicentric, national, opened, not-randomized phase Ib. Three doses of afatinib (20, 30 and 40 Mg per day) will be studied in combination with the fixed standard doses of docetaxel and cisplatin. For each dose level, beginning with smallest (20 Mg per day of afatinib), 3 to 6 patients will be treated at maximum, i.e. 3 cycles of three weeks treatment each one (9 weeks on the whole). The next dose level will be studied only if the previous dose is well tolerated for the period of the first 4 weeks observation of the treatment (1st cycle more first week of the 2nd cycle). Once the MTD is determined, four additional patients will be treated with this dose. A maximum of 22 patients should be included in this study. The total duration of the study is estimated at 18 months. In case of major safety problems, the study may be stopped earlier. In short, the preclinical data, pharmacological and clinical on afatinib indicate that the benefit-risk ratio can be regarded as positive and that the association of afatinib with cisplatin and docetaxel could be effective in patients with head and neck squamous cell carcinoma potentially resulting in an extension of time to progression.
Detailed description
Cancers of the upper aerodigestive tract correspond in the Western countries about 5% of cancers. They are treated by surgery, radiotherapy, and chemotherapy. Although progress in radio chemotherapy have reduced mortality and increase the rates of organ preservation in patients with locally advanced head and neck cancers, they have metastatic risk or particularly high local recurrence. The induction chemotherapy is a first-line treatment of cancer in which the patient receives doses of chemotherapy allowing to obtain a significant reduction in tumor size, and thus to avoid the surgery and to treat the tumor then by radiotherapy alone or combine by certain drugs. The standard treatment of induction chemotherapy currently used for the carcinoma of aerodigestive tract is TPF compose of 3 drugs: the docetaxel (or Taxotere®, T), the cisplatin (P) and the 5-fluorouracil (or 5FU, F). Despite of the relative efficacy of this treatment, which provides a survival benefit, it is necessary to find a combination of induction to be more effective and less toxic. That is why this study intended to check if a new combination called TPA in which the fluorouracil (F) is replaced by the afatinib (A), will be more beneficial. The afatinib is a powerful and irreversible inhibitor of the EGFR (human Epidermal Growth Factor Receptor type 1), HER2 and HER 4. The EGFR is associated with a pejorative prognosis and resistance to the treatments through its role in the proliferation (multiplication of tumoral cells), the cell survival and replication and angiogenesis (process of growth of new blood-vessels, vital in the growth of the malignant tumors). Afatinib has proved effective in patients in with local recurrence or metastatic squamous cell carcinoma of the head and neck after first line cisplatin based and tolerance is correct.
The rational of this study is based on the following elements:
- Cisplatin and docetaxel on the one hand and the afatinib on the other hand have proved effectiveness in head and neck cancers. The tolerance of their association is not known.
- In addition, several broad randomized trials have shown that it is possible to improve the effectiveness of induction chemotherapy in locally advanced head and neck carcinoma by the addition of Taxotere® to the cisplatin-5FU.
- Independently, it has been shown in carcinoma of the upper aerodigestive tract with recurrence or metastatic, that an anti-EGFR targeted therapy by cetuximab could improve the effectiveness of chemotherapy with cisplatin-5FU More recently, Taxotere® and Cisplatin + Cetuximab (or Erbitux®) combination for the treatment of head and neck squamous cell carcinoma has been tested in a broad study of phase II showing the good feasibility of this combination and a particularly high rate of tumoral response.
- Finally a comparative study of cetuximab versus afatinib showed an advantage in terms of tumoral response in support of afatinib.
From all these observations, the investigators can hypothesize that the addition of afatinib to the docetaxel and the cisplatin could be an induction treatment for locally advanced carcinoma both innovating and promising. Indeed, this regimen appears optimized in terms of efficiency, incorporating both the combination of the most active cytotoxic agents, Taxotere® and the cisplatin, but also potentially more effective than Erbitux®.
The purpose of the study is to determine the Maximum Tolerated Dose (MTD) of afatinib administrated in combination with docetaxel (Taxotere®) and cisplatin in induction chemotherapy of locally advanced head and neck carcinoma in order to move to a phase II, allowing the comparison with standard induction chemotherapy TPF.
It is a multicentric, national, opened, not-randomized phase Ib. Three doses of the afatinib (20, 30 and 40 Mg per day) will be studied in combination with the fixed standard doses of the docetaxel and the cisplatin. For each dose level, beginning with smallest (20 Mg per day of afatinib), 3 to 6 patients will be treated at maximum, i.e. 3 cycles of three weeks treatment each one (9 weeks on the whole). The next dose level will be studied only if the previous dose is well tolerated for the period of the first 4 weeks observation of the treatment (1st cycle and first week of the 2nd cycle). Once the MTD is determine, four additional patients will be treated with this dose. A maximum of 22 patients should be included in this study. The total duration of the study is estimated at 18 months. In case of major safety problems, the study may be stopped earlier. In short, the preclinical data, pharmacological and clinical on afatinib indicate that the benefit-risk ratio can be regarded as positive and that the association of afatinib with cisplatin and docetaxel could be effective in patients with head and neck squamous cell carcinoma potentially resulting in an extension of time to progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction chemotherapy TPA | Experimental | Drug: Taxotere, Cisplatin, Afatinib3 Cycles of induction chemotherapy TPA : (Taxotere, Cisplatin, Afatinib) 1 cycle = 3 weeks, three cycles of treatment in total (or 9 weeks) Docetaxel 75 mg / m2 at D1 Cisplatin 75 mg / m 2 at D1 Afatinib: x mg / day D2 to D21 by level: (Level 1: 20 mg / day; Level 2: 30 mg / day; Level 3: 40 mg / day) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥18 years and ≤70 years
- Patient in first line treatment of Locally Advanced HNSCC, histologically proven non-metastatic
- At least one measurable lesion (RECIST)
- Eligible patient for standard induction chemotherapy in the opinion of the investigator; PS ECOG < 2
- Left ventricular function with ejection fraction at rest > 50% or as normal institutional values Haematological function
Key exclusion criteria (20 listed)
- •Previous treatment with chemotherapy, radiation therapy or targeted therapy for head and neck cancer; uncontrolled Respiratory, cardiac, hepatic or renal diseases.
- Cardiovascular Abnormalities considered clinically important as congestive heart failure NYHA stage ≥ III, unstable angina or myocardial infarction within the past 6 months, or arrhythmia low controlled, uncontrolled hypertension by treatment (systolic BP ≥ 160 mmHg and/or diastolic BP≥ 90 mmHg).
- Impairment of left ventricular function with an ejection fraction ≤ 50%; Stroke within 6 months prior to inclusion.
- Severe thromboembolic history within 6 months prior to inclusion.
- Lengthening of the corrected QT interval with QTc> 480 msec according to the formula Bazet; Bradycardia; Electrolyte disturbances
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 |
|---|---|---|
| Taxotere, Cisplatin, Afatinib | Drug | Induction chemotherapy TPA |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: During the first 4 weeks of treatment for each patient of the bearing.
The main objective is to determine the Maximum Tolerated Dose (MTD) of afatinib in combination with docetaxel and cisplatin chemotherapy TPA induction in locally advanced head and neck carcinomas in order to move a phase II for comparison with induction chemotherapy "of reference "TPF (Taxotere, cisplatin and 5-fluorouracil).
2 secondary outcomes
Tolerance
Time frame: 12 weeks
Efficacy
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Related InfoLink 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.
Didier CUPISSOL, MD study chair
GORTEC
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 Taxotere, Cisplatin, Afatinib in people with HNSCC, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site 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 14 inclusion and 20 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 27 Oct 2017. 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 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Tolerated Dose (MTD) (time frame: During the first 4 weeks of treatment for each patient of the bearing.). 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 27 Oct 2017.