Head and Neck Squamous Cell CarcinomaPhase 2NCT00957853
Preoperative Treatment With Cetuximab and/or IMC-A12
A Phase 2 study testing Cetuximab, IMC-A12 and Surgical tumor resection in people with Head and Neck Squamous Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to give cetuximab and/or IMC-A12 before surgery for squamous cell carcinoma of the head and neck, in order to learn if these study drugs may cause changes in biomarkers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Cetuximab, IMC-A12 and Surgical tumor resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2011to 15 Aug 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically-confirmed diagnosis of squamous cell carcinoma of the head and neck (excluding carcinomas of the nasopharynx types II and III according to the World Health Organization criteria), for whom surgical resection of the tumor is planned as part of the treatment. Patients with skin squamous cell carcinomas of the head and neck region will also be included in this study.
- There is availability of a baseline, paraffin-embedded, tumor specimen for biomarker evaluation. No anti-neoplastic treatment is allowed between the time from obtaining the baseline tumor specimen and randomization. If a baseline tumor specimen is not available, a biopsy of the tumor will be performed prior to randomization.
- Prior treatment with biological agents targeted to the epidermal growth factor receptor is allowed, provided the time from last exposure to this treatment was >/= 6 months.
- The patient has a fasting serum glucose < 130 mg/dL and HbA1C < 7.0%. Patients with a history of diabetes mellitus are allowed to participate, provided that they are on a stable dietary or therapeutic regimen for this condition.
- The patient has adequate renal function, defined by serum creatinine </= 1.5 x the institutional upper limit of normal (ULN), or creatinine clearance >/=60 mL/min for patients with creatinine levels above the ULN.
- Because the teratogenicity of cetuximab and IMC-A12 is not known, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
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- The patient is age >/= 18 years.
- The patient or the patient's legally authorized representative has the ability to understand and the willingness to sign a written informed consent document.
- ECOG performance status of 0-2.
Who cannot join
- Patients receiving any other agent (investigational or not) with potential anti-neoplastic activity within 3 weeks prior to obtaining the baseline tumor specimen for biomarker evaluation.
- Patients receiving concomitant radiation.
- Prior treatment with an agent targeted at the insulin-like growth factor-1 receptor.
- History of allergic reactions attributed to compounds of chemical and biological composition similar to those of cetuximab or IMC-A12.
- Pregnant patients, or patients who are breast feeding (patients who have a positive pregnancy test within the first 30 days before the first dose of treatment are excluded).
- Patients with uncontrolled illnesses which, in the opinion of the investigator, could be aggravated by the administration of the study drug(s).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: An Exploratory Study to Assess the Modulation of Biomarkers in Patients With Squamous Cell Carcinomas of the Head and Neck Randomized to Receive Preoperative Treatment With Cetuximab and/or IMC-A12, an Anti-insulin-like Growth Factor-1 Receptor Monoclonal Antibody
The goal of this clinical research study is to give cetuximab and/or IMC-A12 before surgery for squamous cell carcinoma of the head and neck, in order to learn if these study drugs may cause changes in biomarkers. Biomarkers are chemical "markers" in the blood and/or tissue that may be related to a reaction to study treatment.
The safety of the study treatments will also be studied.
Read the detailed description
The Study Drugs Cetuximab and IMC-A12 are both designed to block proteins that are thought to cause cancer cells to grow. This may help to slow the growth of tumors.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups. There is an equal chance of being assigned to any group.
- Group 1 will receive cetuximab alone.
- Group 2 will receive IMC-A12 alone.
- Group 3 will receive cetuximab and IMC-A12 in combination.
If you are assigned to group 2 or 3 you will have a hearing test within 90 days before starting treatment with the study drug.
Study Treatment:
Groups 1 and 3:
Cetuximab will be given by vein on Days 1 and 8. The first dose will be given over 2 hours. The second dose will be given over 1 hour.
To lower the risk of allergic reaction, Groups 1 and 3 will also receive diphenhydramine by mouth or by vein before the first dose of cetuximab. If the study doctor decides it is needed, diphenhydramine may also be given before the second dose of cetuximab (and the third, if applicable).
Groups 2 and 3:
IMC-A12 will be given by vein over 1 hour on Days 1 and 8.
All Groups:
You will have surgery on Day 10. If for some reason the surgery is delayed, the study doctor may decide that you will receive a third dose of your assigned study drug(s) on Day 15. In that case, cetuximab will be given over 1 hour and/or IMC-A12 will be given over 1 hour, depending on which group you are in.
You will sign a separate consent form that describes the surgery and its risks in more detail.
Study Tests:
Within 5 days before your second dose of study drug(s), and again within 5 days before your third dose (if applicable), the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will be asked about any side effects you may be experiencing.
- You will have a physical exam, including measurement of vital signs.
- Blood (about 3 teaspoons) will be drawn for routine tests.
On the day before surgery, you will have a CT scan or MRI of the head and neck. If needed, these tests can instead be done before surgery but sometime after the last dose of the study drug(s).
On the day of surgery, blood (about 3 teaspoons) will be drawn for routine tests and your vital signs will be measured. If needed, these tests can instead be done up to 2 days before surgery.
Length of Study Drug Dosing:
After your last dose of the study drug(s), on Day 8 or Day 15, your participation in the study treatment period will be over. You will be taken off the study drug(s) early if the disease gets worse or intolerable side effects occur.
Follow-Up:
If you return to the clinic within 30 days after surgery, the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about any side effects that may have occurred.
Otherwise if you do not have a visit scheduled during that time, the study staff will call you by phone instead. You will be asked how you are doing.
If you are experiencing side effects from the study drug(s) at the time of the follow-up visit or call, you may have additional follow-up if the doctor decides it is needed. The follow-up tests, procedures, and schedule will be the doctor's decision depending on the side effects.
You will have a repeat hearing test within 90 days after surgery if you received at least 1 dose of IMC-A12.
Long-Term Follow-Up:
On a long-time basis after surgery, the study staff may review your medical record to collect information about your health. During this time, you or your family members may be contacted and asked to confirm or provide information about your health. The contact may occur during clinic visits or by phone, mail, or e-mail.
This is an investigational study. Cetuximab is commercially available and FDA approved to treat squamous cell carcinoma that has spread or come back, in patients who did not respond to platinum-based therapy.
Using cetuximab in combination with surgery is investigational.
IMC-A12 is not FDA approved or commercially available. At this time, IMC-A12 is only being used in research.
Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Cetuximab, IMC-A12, Surgical tumor resection
- Keywords
- Head and Neck Cancer, Squamous cell carcinoma of the head and neck, HNSCC, Cetuximab, IMC-A12, Tumor, Biomarkers, Phospho-AKT, Surgical resection
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called C225, Erbitux, IMC-C225
First dose of 400 mg/m^2 by vein on Days 1 and 8 over 2 hours, second dose of 250 mg/m^2 on week 2 and 3 (if applicable) given over 1 hour.
IMC-A12Drug
6 mg/kg/week by vein on Days 1 and 8 over 1 hour on weeks 1 and 2 and 3 (if applicable).
Surgical tumor resectionProcedure or surgery
Surgical tumor resection on Day 10.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Cetuximab | Experimental | Cetuximab: 400 mg/m2 i.v. over 120 minutes on week 1, and 250 mg/m2 on week 2 and 3 i.v. over 60 minutes Receives: Drug: Cetuximab; Procedure: Surgical tumor resection |
| Group 2: IMC-A12 | Experimental | IMC-A12: 6 mg/kg/week i.v. over 1 hour on weeks 1 and 2 and 3. Receives: Drug: IMC-A12; Procedure: Surgical tumor resection |
| Group 3: Cetuximab + IMC-A12 | Experimental | Cetuximab: 400 mg/m2 i.v. over 120 minutes on week 1, and 250 mg/m2 on week 2 and 3 i.v. over 60 minutes.
IMC-A12: 6 mg/kg/week i.v. over 1 hour on weeks 1 and 2 and 3. Receives: Drug: Cetuximab; Drug: IMC-A12; Procedure: Surgical tumor resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AKT Modulation
An IHC scoring system used to quantify phospho-Akt levels based on staining intensity x extension. Staining intensity graded as undetectable (0), weak (1), medium (2), or strong (3). Staining extension graded as percentage of positive cells per high power field at x20 magnification. Final score will therefore range from 0 to 300. Modulation of phospho-Akt (difference in IHC score between the surgical specimen and the baseline biopsy) and other biomarkers compared between any two of the three treatment arms with the use of the Wilcoxon rank sum test. Type I error of alpha=0.05 (two-sided test) used. Correlation between biomarkers and molecular response or toxicity performed in an exploratory fashion.
Measured: Biopsy at baseline and surgery (surgery should be within 10 days of last treatment)
Secondary outcomes (1)
Number of Participants With Objective Response
Objective response to treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: up to 4 months post treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study start17 Oct 2011
- Primary completion15 Aug 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Maura Gillison, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957853
- Sponsor's protocol ID
- 2008-0342
- Other IDs
- NCI-2011-03039
- Status last verified
- Mar 2020
- First submitted
- 12 Aug 2009
- Last updated
- 19 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Assess the Modulation of Biomarkers in Patients With Squamous Cell Carcinomas of the Head and Neck Randomized to Receive Preoperative Treatment With Cetuximab and/or IMC-A12, an Anti-insulin-like Growth Factor-1 Receptor Monoclonal Antibody
- ClinicalTrials.gov ID
- NCT00957853
- Acronym / sponsor ID
- 2008-0342
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Head and Neck Cancer, Squamous cell carcinoma of the head and neck, HNSCC, Cetuximab, IMC-A12, Tumor, Biomarkers, Phospho-AKT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 17 Oct 2011 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Posted 19 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to give cetuximab and/or IMC-A12 before surgery for squamous cell carcinoma of the head and neck, in order to learn if these study drugs may cause changes in biomarkers. Biomarkers are chemical "markers" in the blood and/or tissue that may be related to a reaction to study treatment.
The safety of the study treatments will also be studied.
Detailed description
The Study Drugs Cetuximab and IMC-A12 are both designed to block proteins that are thought to cause cancer cells to grow. This may help to slow the growth of tumors.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups. There is an equal chance of being assigned to any group.
- Group 1 will receive cetuximab alone.
- Group 2 will receive IMC-A12 alone.
- Group 3 will receive cetuximab and IMC-A12 in combination.
If you are assigned to group 2 or 3 you will have a hearing test within 90 days before starting treatment with the study drug.
Study Treatment:
Groups 1 and 3:
Cetuximab will be given by vein on Days 1 and 8. The first dose will be given over 2 hours. The second dose will be given over 1 hour.
To lower the risk of allergic reaction, Groups 1 and 3 will also receive diphenhydramine by mouth or by vein before the first dose of cetuximab. If the study doctor decides it is needed, diphenhydramine may also be given before the second dose of cetuximab (and the third, if applicable).
Groups 2 and 3:
IMC-A12 will be given by vein over 1 hour on Days 1 and 8.
All Groups:
You will have surgery on Day 10. If for some reason the surgery is delayed, the study doctor may decide that you will receive a third dose of your assigned study drug(s) on Day 15. In that case, cetuximab will be given over 1 hour and/or IMC-A12 will be given over 1 hour, depending on which group you are in.
You will sign a separate consent form that describes the surgery and its risks in more detail.
Study Tests:
Within 5 days before your second dose of study drug(s), and again within 5 days before your third dose (if applicable), the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will be asked about any side effects you may be experiencing.
- You will have a physical exam, including measurement of vital signs.
- Blood (about 3 teaspoons) will be drawn for routine tests.
On the day before surgery, you will have a CT scan or MRI of the head and neck. If needed, these tests can instead be done before surgery but sometime after the last dose of the study drug(s).
On the day of surgery, blood (about 3 teaspoons) will be drawn for routine tests and your vital signs will be measured. If needed, these tests can instead be done up to 2 days before surgery.
Length of Study Drug Dosing:
After your last dose of the study drug(s), on Day 8 or Day 15, your participation in the study treatment period will be over. You will be taken off the study drug(s) early if the disease gets worse or intolerable side effects occur.
Follow-Up:
If you return to the clinic within 30 days after surgery, the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about any side effects that may have occurred.
Otherwise if you do not have a visit scheduled during that time, the study staff will call you by phone instead. You will be asked how you are doing.
If you are experiencing side effects from the study drug(s) at the time of the follow-up visit or call, you may have additional follow-up if the doctor decides it is needed. The follow-up tests, procedures, and schedule will be the doctor's decision depending on the side effects.
You will have a repeat hearing test within 90 days after surgery if you received at least 1 dose of IMC-A12.
Long-Term Follow-Up:
On a long-time basis after surgery, the study staff may review your medical record to collect information about your health. During this time, you or your family members may be contacted and asked to confirm or provide information about your health. The contact may occur during clinic visits or by phone, mail, or e-mail.
This is an investigational study. Cetuximab is commercially available and FDA approved to treat squamous cell carcinoma that has spread or come back, in patients who did not respond to platinum-based therapy.
Using cetuximab in combination with surgery is investigational.
IMC-A12 is not FDA approved or commercially available. At this time, IMC-A12 is only being used in research.
Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Cetuximab | Experimental | Drug: Cetuximab, Procedure: Surgical tumor resectionCetuximab: 400 mg/m2 i.v. over 120 minutes on week 1, and 250 mg/m2 on week 2 and 3 i.v. over 60 minutes |
| Group 2: IMC-A12 | Experimental | Drug: IMC-A12, Procedure: Surgical tumor resectionIMC-A12: 6 mg/kg/week i.v. over 1 hour on weeks 1 and 2 and 3. |
| Group 3: Cetuximab + IMC-A12 | Experimental | Drug: Cetuximab, Drug: IMC-A12, Procedure: Surgical tumor resectionCetuximab: 400 mg/m2 i.v. over 120 minutes on week 1, and 250 mg/m2 on week 2 and 3 i.v. over 60 minutes. IMC-A12: 6 mg/kg/week i.v. over 1 hour on weeks 1 and 2 and 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically-confirmed diagnosis of squamous cell carcinoma of the head and neck (excluding carcinomas of the nasopharynx types II and III according to the World Health Organization criteria), for whom surgical resection of the tumor is planned as part of the treatment. Patients with skin squamous cell carcinomas of the head and neck region will also be included in this study.
- There is availability of a baseline, paraffin-embedded, tumor specimen for biomarker evaluation. No anti-neoplastic treatment is allowed between the time from obtaining the baseline tumor specimen and randomization. If a baseline tumor specimen is not available, a biopsy of the tumor will be performed prior to randomization.
- Prior treatment with biological agents targeted to the epidermal growth factor receptor is allowed, provided the time from last exposure to this treatment was >/= 6 months.
- The patient has a fasting serum glucose < 130 mg/dL and HbA1C < 7.0%. Patients with a history of diabetes mellitus are allowed to participate, provided that they are on a stable dietary or therapeutic regimen for this condition.
- The patient has adequate renal function, defined by serum creatinine </= 1.5 x the institutional upper limit of normal (ULN), or creatinine clearance >/=60 mL/min for patients with creatinine levels above the ULN.
Key exclusion criteria (6 listed)
- Patients receiving any other agent (investigational or not) with potential anti-neoplastic activity within 3 weeks prior to obtaining the baseline tumor specimen for biomarker evaluation.
- Patients receiving concomitant radiation.
- Prior treatment with an agent targeted at the insulin-like growth factor-1 receptor.
- History of allergic reactions attributed to compounds of chemical and biological composition similar to those of cetuximab or IMC-A12.
- Pregnant patients, or patients who are breast feeding (patients who have a positive pregnancy test within the first 30 days before the first dose of treatment are excluded).
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 |
|---|---|---|
| CetuximabAlso: C225, Erbitux, IMC-C225First dose of 400 mg/m^2 by vein on Days 1 and 8 over 2 hours, second dose of 250 mg/m^2 on week 2 and 3 (if applicable) given over 1 hour. | Drug | Group 1: Cetuximab, Group 3: Cetuximab + IMC-A12 |
| IMC-A126 mg/kg/week by vein on Days 1 and 8 over 1 hour on weeks 1 and 2 and 3 (if applicable). | Drug | Group 2: IMC-A12, Group 3: Cetuximab + IMC-A12 |
| Surgical tumor resectionSurgical tumor resection on Day 10. | Procedure or surgery | Group 1: Cetuximab, Group 2: IMC-A12, Group 3: Cetuximab + IMC-A12 |
Primary outcome
AKT Modulation
Time frame: Biopsy at baseline and surgery (surgery should be within 10 days of last treatment)
An IHC scoring system used to quantify phospho-Akt levels based on staining intensity x extension. Staining intensity graded as undetectable (0), weak (1), medium (2), or strong (3). Staining extension graded as percentage of positive cells per high power field at x20 magnification. Final score will therefore range from 0 to 300. Modulation of phospho-Akt (difference in IHC score between the surgical specimen and the baseline biopsy) and other biomarkers compared between any two of the three treatment arms with the use of the Wilcoxon rank sum test. Type I error of alpha=0.05 (two-sided test) used. Correlation between biomarkers and molecular response or toxicity performed in an exploratory fashion.
1 secondary outcome
Number of Participants With Objective Response
Time frame: up to 4 months post treatment start
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center 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.
Maura Gillison, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab, IMC-A12 and Surgical tumor resection in people with Head and Neck Squamous Cell Carcinoma, run by M.D. Anderson Cancer Center 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 9 inclusion and 6 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 19 Mar 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AKT Modulation (time frame: Biopsy at baseline and surgery (surgery should be within 10 days of last treatment)). 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 19 Mar 2020.