Colorectal CancerPhase 2NCT01442649
Efficacy of Chemotherapy, Associated to Either Cetuximab or Bevacizumab, in KRAS Wild-type Metastatic Colorectal Cancer Patients With Progressive Disease After Receiving First-line Treatment With Bevacizumab
A Phase 2 study testing Oxaliplatin, Folinic Acid and 5-fluoro-uracil in people with Colorectal Cancer, run by UNICANCER at 1 site in France.
Trial summary
The main objective is to evaluate progression-free survival (PFS) at 4 months. The secondary objectives are to evaluate the objective response rate (OR) (= complete responses (CR) and partial responses (PR)) according to the RECIST v1.1 criteria, the progression-free survival (PFS), the overall survival (OS), the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Oxaliplatin, Folinic Acid and 5-fluoro-uracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to 31 Dec 2017
- Phase
- Phase 2
- 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 adenocarcinoma of the colon expressing non-mutated (wild-type) KRAS.
- Progressive metastatic disease after first-line treatment with chemotherapy alone: based on 5-FU (iv or per os) with irinotecan or oxaliplatin associated to bevacizumab.
- Prior adjuvant chemotherapy (of the primary tumor) with fluoropyrimidine and oxaliplatin is allowed if the time interval between the end of this chemotherapy and the beginning of the first-line metastatic treatment is ≥ 6 months.
- Measurable disease (at least one measurable metastatic lesion) according to the RECIST V1.1 criteria (the lesion should not be located in a previous field of radiation).
- Previous radiotherapy is authorized if discontinued ≥ 15 days prior to randomization and if the measurable metastatic lesions are outside the radiation area.
- Sites of disease evaluated within 28 days prior to randomization with thoracic-abdominal-pelvic CT scan (or abdominal-pelvic MRI plus Chest Xray)
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- Age ≥18 years
- Patient with ECOG 0 or 1
- Life Expectancy ≥ 3 months
- Hematologic function (polynuclear neutrophiles ≥ 1.5.109/L ; platelets ≥ 100.109/L ; hemoglobin ≥ 9 g/dL
- Hepatic transaminases ≤ 2.5 times upper limit of normal (ULN) (≤ 5 ULN in case of hepatic metastases), alkaline phosphatases ≤ 2.5 ULN (≤ 5 ULN in case of hepatic metastases), total bilirubinemia ≤ 1.5 ULN
- Renal function (creatinemia ≤1.5 ULN; creatine clearance ≥ 50 mL/mn (Cockcroft and Gault) ; urine test strip < 2+. If proteinuria is ≥ +2 at inclusion, the serum urea test must be redone and show proteinuria ≤ 1 g/L within 24 h)
- Completion of the EORTC QLQ-C30 quality of life form
- Negative pregnancy test for women of child-bearing age
- Information given to the patient and signed informed consent
- Public Health insurance coverage
Who cannot join
- Known meningeal or brain metastases
- Pre-treatment with anti-EGFR
- Specific contraindication or known hypersensitivity to one treatment product
- Patient with known allergy or hypersensitivity to monoclonal antibodies (bevacizumab, cetuximab
- Clinically significant affection of the coronaries or myocardial infarction within 6 months prior to inclusion.
- Peripheral neuropathy of grade > 1 (CTCAE scale version 4.0).
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- Known depletion of the dihydropyrimidine dehydrogenase (DPD).
- Acute intestinal obstruction or sub-obstruction, history of inflammatory intestinal disease or extended resection of the small intestine. Presence of a colic prosthesis.
- Uncontrolled Arterial hypertension (systolic pressure > 150 mmHg and/or diastolic pressure > 100 mmHg with and without antihypertensive medication. Patients with high hypertension are eligible if antihypertensive medication lowers their arterial pressure to the level of acceptability specified by the inclusion criteria.
- History of hypertensive crisis or hypertensive encephalopathy
- Other concomitant malignancy or history cancer (except carcinoma in situ of the cervix, or non melanoma skin cancer, with curative intent treatment, when considered in complete remission for at least 5 years before randomization.
- Any treatment including an experimental drug, or participation in another clinical trial within 28 days preceding inclusion.
- Persons deprived of liberty or under guardianship.
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II, Multicentric Randomized Trial, Evaluating the Efficacy of Fluoropyrimidine-based Standard Chemotherapy, Associated to Either Cetuximab or Bevacizumab, in KRAS Wild-type Metastatic Colorectal Cancer Patients With Progressive Disease After Receiving First-line Treatment With Bevacizumab
The main objective is to evaluate progression-free survival (PFS) at 4 months.
The secondary objectives are to evaluate the objective response rate (OR) (= complete responses (CR) and partial responses (PR)) according to the RECIST v1.1 criteria, the progression-free survival (PFS), the overall survival (OS), the overall survival from the date of the first-line chemotherapy used on the metastatic disease, the treatment tolerance (NCI CTC AE V4 criteria, except for peripheral neurological toxicity (Lévi Scale)), the quality of life according to the EORTC QLQ-C30 criteria.
The objectives of the biological study are to evaluate potentially predictive anti-EGFR and anti-VEGF response factors and CEC rates as predictive biomarkers for the efficacy of bevacizumab associated with chemotherapy in mCRC treatment.
- Conditions
- Colorectal Cancer
- Being tested
- Oxaliplatin, Folinic Acid, 5-fluoro-uracil, Irinotecan, Bevacizumab
- Keywords
- Adenocarcinoma, Metastatic, Second-line treatment, Progressive disease after first-line treatment with bevacizumab, Non-mutated (wild-type) KRAS.
- Medical subject headings
- Colorectal Neoplasms, Adenocarcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
85mg/m² over 120 mn on D1 every 2 weeks up to progression or toxicity
Folinic AcidDrug
400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1 (in the same time that oxaliplatin or irinotecan) every 2 weeks up to progression or toxicity
5-fluoro-uracilDrug
400mg/m² in bolus on D1, then 2400mg/m² over 46 h every 2 weeks up to progression or toxicity
IrinotecanDrug
180 mg/m2 over 90 mn IV on D1 every 2 weeks up to progression or toxicity
BevacizumabDrug
5 mg/kg IV over 90 mn on D1 every 2 weeks up to progression or toxicity
CetuximabDrug
500mg/m² on D1 every 2 weeks up to progression or toxicity
| Study group | Role | What they receive |
|---|---|---|
| Arm A : bevacizumab + fluoropyrimidine-based chemotherapy | Experimental | Every 2 weeks :
- mFOLFOX6 : Oxaliplatin 85 mg/m2 over 120 mn IV on D1, Folinic Acide 400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1, 5-fluoro-uracil 400 mg/m² in bolus IV on D1 and 5-fluoro-uracil 2400 mg/m² in infusion IV over 46 h.
OR
- FOLFIRI : Irinotecan 180 mg/m2 en 90 mn IV on day D1, Folinic acid 400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1, 5-fluoro-uracil 400 mg/m² in bolus IV on D1 and 5-fluoro-uracil 2400 mg/m² in infusion IV over 46 h.
AND
Bevacizumab 5 mg/kg IV every 2 weeks. Receives: Drug: Oxaliplatin; Drug: Folinic Acid; Drug: 5-fluoro-uracil; Drug: Irinotecan; Drug: Bevacizumab |
| Arm B : cetuximab + fluoropyrimidine-based chemotherapy | Experimental | Every 2 weeks :
- mFOLFOX6 : Oxaliplatin 85 mg/m2 over 120 mn IV on D1, Folinic Acide 400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1, 5-fluoro-uracil 400 mg/m² in bolus IV on D1 and 5-fluoro-uracil 2400 mg/m² in infusion IV over 46 h.
OR
- FOLFIRI : Irinotecan 180 mg/m2 en 90 mn IV on day D1, Folinic acid 400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1, 5-fluoro-uracil 400 mg/m² in bolus IV on D1 and 5-fluoro-uracil 2400 mg/m² in infusion IV over 46 h.
AND
Cetuximab : 500 mg/m² IV every 2 weeks Receives: Drug: Oxaliplatin; Drug: Folinic Acid; Drug: 5-fluoro-uracil; Drug: Irinotecan; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) at 4 months
Progression-free survival is defined as the time from randomization to progression (RECIST v1.1 criteria) or death. Patients alive without progression will be censored at the last follow-up.
Measured: 4 months
Secondary outcomes (6)
Objective response rate (OR)
The objective response rate is defined as the occurence of a complete response [CR] or a partial responses [PR] according to RECIST V1.1 between date of randomization and date of end of treatment. It will be evaluated by the investigator with RECIST v1.1 criteria every 6 weeks up to disease progression.
Measured: 12 months
Progression-free survival (PFS)
Progression-free survival is defined as the time from randomization to progression (RECIST v1.1 criteria) or death. Patients alive without progression will be censored at the last follow-up.
Measured: 4 months
Overall survival (OS)
Overall survival is defined as the time from randomization to death any cause or last follow-up (censored data).
Measured: until death or progression (24 months)
Overall survival from the date of the first-line chemotherapy used on the metastatic disease
Overall survival from the date of the first-line chemotherapy used on the metastatic disease is defined as the time from the first day of the first-line chemotherapy used on the metastatic disease to death any cause or last follow-up news (censored data).
Measured: until death or progression (24 months)
Treatment tolerance
Tolerance of the treatment will be based on toxicities of evaluated products by clinical and biological measurements (NCIC/CTC (CTCAE V4) criteria, except for peripheral neuropathy toxicity (Lévi scale)).
Measured: Every 2 weeks, during the treatment.
Quality of life
Quality of life will be evaluated with the EORTC QLQ - C30.
Measured: every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startDec 2010
- Primary completionOct 2015
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe 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
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaafar BENNOUNA, Dr, Principal investigator, Centre René GauducheauChristophe BORG, Pr, Principal investigator, CHU Jean Minjoz-BESANCONChristian BOREL, Dr, Principal investigator, Centre Paul Strauss-STRASBOURGJean-Pierre DELORD, Pr, Principal investigator, Institut Claudius Regaud-TOULOUSEChristophe BORG, Pr., Principal investigator, Centre Hospitalier du Mittan-MONTBELIARDJean-François SEITZ, Pr, Principal investigator, CHU Timone-MARSEILLEThierry CONROY, Pr, Principal investigator, Centre Alexis Vautrin-VANDOEUVRE LES NANCYRoger FAROUX, Dr, Principal investigator, CHD Vendée-LA ROCHE SUR YON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442649
- Sponsor's protocol ID
- PRODIGE 18 / ACCORD 22/0906
- Status last verified
- Jan 2022
- First submitted
- 5 Sep 2011
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bennouna J, Hiret S, Bertaut A, Bouche O, Deplanque G, Borel C, Francois E, Conroy T, Ghiringhelli F, des Guetz G, Seitz JF, Artru P, Hebbar M, Stanbury T, Denis MG, Adenis A, Borg C. Continuation of Bevacizumab vs Cetuximab Plus Chemotherapy After First Progression in KRAS Wild-Type Metastatic Colorectal Cancer: The UNICANCER PRODIGE18 Randomized Clinical Trial. JAMA Oncol. 2019 Jan 1;5(1):83-90. doi: 10.1001/jamaoncol.2018.4465.
PubMed 30422156
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multicentric Randomized Trial, Evaluating the Efficacy of Fluoropyrimidine-based Standard Chemotherapy, Associated to Either Cetuximab or Bevacizumab, in KRAS Wild-type Metastatic Colorectal Cancer Patients With Progressive Disease After Receiving First-line Treatment With Bevacizumab
- ClinicalTrials.gov ID
- NCT01442649
- Acronym / sponsor ID
- PRODIGE 18 / ACCORD 22/0906
- Conditions
- Colorectal Cancer
- Keywords
- Adenocarcinoma, Metastatic, Second-line treatment, Progressive disease after first-line treatment with bevacizumab, Non-mutated (wild-type) KRAS.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Dec 2010 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 28 Sep 2011 (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 main objective is to evaluate progression-free survival (PFS) at 4 months.
The secondary objectives are to evaluate the objective response rate (OR) (= complete responses (CR) and partial responses (PR)) according to the RECIST v1.1 criteria, the progression-free survival (PFS), the overall survival (OS), the overall survival from the date of the first-line chemotherapy used on the metastatic disease, the treatment tolerance (NCI CTC AE V4 criteria, except for peripheral neurological toxicity (Lévi Scale)), the quality of life according to the EORTC QLQ-C30 criteria.
The objectives of the biological study are to evaluate potentially predictive anti-EGFR and anti-VEGF response factors and CEC rates as predictive biomarkers for the efficacy of bevacizumab associated with chemotherapy in mCRC treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A : bevacizumab + fluoropyrimidine-based chemotherapy | Experimental | Drug: Oxaliplatin, Drug: Folinic Acid, Drug: 5-fluoro-uracil, Drug: Irinotecan, Drug: BevacizumabEvery 2 weeks : - mFOLFOX6 : Oxaliplatin 85 mg/m2 over 120 mn IV on D1, Folinic Acide 400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1, 5-fluoro-uracil 400 mg/m² in bolus IV on D1 and 5-fluoro-uracil 2400 mg/m² in infusion IV over 46 h. OR - FOLFIRI : Irinotecan 180 mg/m2 en 90 mn IV on day D1, Folinic acid 400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1, 5-fluoro-uracil 400 mg/m² in bolus IV on D1 and 5-fluoro-uracil 2400 mg/m² in infusion IV over 46 h. AND Bevacizumab 5 mg/kg IV every 2 weeks. |
| Arm B : cetuximab + fluoropyrimidine-based chemotherapy | Experimental | Drug: Oxaliplatin, Drug: Folinic Acid, Drug: 5-fluoro-uracil, Drug: Irinotecan, Drug: CetuximabEvery 2 weeks : - mFOLFOX6 : Oxaliplatin 85 mg/m2 over 120 mn IV on D1, Folinic Acide 400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1, 5-fluoro-uracil 400 mg/m² in bolus IV on D1 and 5-fluoro-uracil 2400 mg/m² in infusion IV over 46 h. OR - FOLFIRI : Irinotecan 180 mg/m2 en 90 mn IV on day D1, Folinic acid 400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1, 5-fluoro-uracil 400 mg/m² in bolus IV on D1 and 5-fluoro-uracil 2400 mg/m² in infusion IV over 46 h. AND Cetuximab : 500 mg/m² IV every 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically or cytologically proven adenocarcinoma of the colon expressing non-mutated (wild-type) KRAS.
- Progressive metastatic disease after first-line treatment with chemotherapy alone: based on 5-FU (iv or per os) with irinotecan or oxaliplatin associated to bevacizumab.
- Prior adjuvant chemotherapy (of the primary tumor) with fluoropyrimidine and oxaliplatin is allowed if the time interval between the end of this chemotherapy and the beginning of the first-line metastatic treatment is ≥ 6 months.
- Measurable disease (at least one measurable metastatic lesion) according to the RECIST V1.1 criteria (the lesion should not be located in a previous field of radiation).
- Previous radiotherapy is authorized if discontinued ≥ 15 days prior to randomization and if the measurable metastatic lesions are outside the radiation area.
Key exclusion criteria (14 listed)
- Known meningeal or brain metastases
- Pre-treatment with anti-EGFR
- Specific contraindication or known hypersensitivity to one treatment product
- Patient with known allergy or hypersensitivity to monoclonal antibodies (bevacizumab, cetuximab
- Clinically significant affection of the coronaries or myocardial infarction within 6 months prior to inclusion.
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 |
|---|---|---|
| Oxaliplatin85mg/m² over 120 mn on D1 every 2 weeks up to progression or toxicity | Drug | Arm A : bevacizumab + fluoropyrimidine-based chemotherapy, Arm B : cetuximab + fluoropyrimidine-based chemotherapy |
| Folinic Acid400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1 (in the same time that oxaliplatin or irinotecan) every 2 weeks up to progression or toxicity | Drug | Arm A : bevacizumab + fluoropyrimidine-based chemotherapy, Arm B : cetuximab + fluoropyrimidine-based chemotherapy |
| 5-fluoro-uracil400mg/m² in bolus on D1, then 2400mg/m² over 46 h every 2 weeks up to progression or toxicity | Drug | Arm A : bevacizumab + fluoropyrimidine-based chemotherapy, Arm B : cetuximab + fluoropyrimidine-based chemotherapy |
| Irinotecan180 mg/m2 over 90 mn IV on D1 every 2 weeks up to progression or toxicity | Drug | Arm A : bevacizumab + fluoropyrimidine-based chemotherapy, Arm B : cetuximab + fluoropyrimidine-based chemotherapy |
| Bevacizumab5 mg/kg IV over 90 mn on D1 every 2 weeks up to progression or toxicity | Drug | Arm A : bevacizumab + fluoropyrimidine-based chemotherapy |
| Cetuximab500mg/m² on D1 every 2 weeks up to progression or toxicity | Drug | Arm B : cetuximab + fluoropyrimidine-based chemotherapy |
Primary outcome
Progression-free survival (PFS) at 4 months
Time frame: 4 months
Progression-free survival is defined as the time from randomization to progression (RECIST v1.1 criteria) or death. Patients alive without progression will be censored at the last follow-up.
6 secondary outcomes
Objective response rate (OR)
Time frame: 12 months
Progression-free survival (PFS)
Time frame: 4 months
Overall survival (OS)
Time frame: until death or progression (24 months)
Overall survival from the date of the first-line chemotherapy used on the metastatic disease
Time frame: until death or progression (24 months)
Treatment tolerance
Time frame: Every 2 weeks, during the treatment.
Quality of life
Time frame: every 6 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 11 Jan 2022.
- Derived from this study: PubMed 30422156Bennouna J, Hiret S, Bertaut A, Bouche O, Deplanque G, Borel C, Francois E, Conroy T, Ghiringhelli F, des Guetz G, Seitz JF, Artru P, Hebbar M, Stanbury T, Denis MG, Adenis A, Borg C. Continuation of Bevacizumab vs Cetuximab Plus Chemotherapy After First Progression in KRAS Wild-Type Metastatic Colorectal Cancer: The UNICANCER PRODIGE18 Randomized Clinical Trial. JAMA Oncol. 2019 Jan 1;5(1):83-90. doi: 10.1001/jamaoncol.2018.4465.
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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.
Jaafar BENNOUNA, Dr principal investigator
Centre René Gauducheau
Christophe BORG, Pr principal investigator
CHU Jean Minjoz-BESANCON
Christian BOREL, Dr principal investigator
Centre Paul Strauss-STRASBOURG
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 Oxaliplatin, Folinic Acid and 5-fluoro-uracil in people with Colorectal Cancer, run by UNICANCER 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 16 inclusion and 14 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 11 Jan 2022. 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 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?
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?
Progression-free survival (PFS) at 4 months (time frame: 4 months). 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 NCT01442649, which also lists 1 linked publication.
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 11 Jan 2022; AzTrials last refreshed its copy on 8 Nov 2026.