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AzTrials

Colorectal CarcinomaPhase 2COLOSOTONCT07124884

5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doublet/Triplet Chemotherapy With Advanced Unresectab

A Phase 2 study testing Administration of experimental treatment association (sotorasib, panitumumab 5FU) in people with Colorectal Carcinoma and KRAS G12C Mutation, run by Federation Francophone de Cancerologie Digestive at 80 sites in 4 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

5-fluorouracil (5-FU) is a standard of care in frail/elderly patients with an unresectable colorectal adenocarcinoma (CRC) in first-line setting. Panitumumab plus Sotorasib are promising in advanced line in KRAS G12C mutated CRC. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Administration of experimental treatment association (sotorasib, panitumumab 5FU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
80 sitesin 4 countries
Study dates
31 Aug 2025to 30 Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Age ≥ 18 years.
  • Histologically proven advanced-stage unresectable locally advanced or metastatic colorectal adenocarcinoma.
  • Proven KRAS G12C mutation as locally assessed by means of an IVDR-compliant test
  • Agreement to participate to biological studies (blood samples for ctDNA and send tumour block).
  • Patient with one these criteria:
  • Patient with WHO PS=2 Patient between 70 and 75 years old with WHO PS 1 Patient ≥ 75 years old
Show all 14Show fewer
  • Measurable lesion according to the Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1).
  • No prior treatment for the metastatic disease. Prior adjuvant chemotherapy is allowed if there is more than 6 months between the end of adjuvant treatment and relapse.
  • Adequate organ function: Hemoglobin > 9 g/dl, Absolute neutrophil count > 1500 /mm3, Platelets > 80 000/mm3, Creatinine clearance rate ≥50 mL/min as calculated using MDRD formula, ALT/AST ≤5×ULN and total bilirubin ≤1.5×ULN.
  • Ability to understand and sign written informed consent to participate in the study.
  • Provides written informed consent for the study.
  • Life expectancy >6 months.
  • Women of childbearing potential must agree to use contraception during the trial treatment and for at least 6 months after discontinuation of the experimental treatments. Men who have sexual relationship with women of childbearing potential must agree to use contraception during treatment and for at least 3 months after discontinuation of the experimental treatments.
  • Patient affiliated to a social security scheme for France, or equivalent for other countries.

Who cannot join

  • Patient with one of these criteria: Patient fit for doublet/triplet regimen Patient with WHO PS 3 or 4 Patient < 75 years old with WHO PS 0 Patient < 70 years old with WHO PS 0 or 1
  • Uncontrolled intercurrent illness including liver (liver cirrhosis Child Pugh B or C) and lung (one second forced expiratory volume <50%) severe insufficiency.
  • Patients with high microsatellite instability (MSI-H) or a tumour with mismatched repair (dMMR).
  • Clinically significant cardiac abnormalities including prior history of any of the following: severe cardiomyopathy, congestive heart failure of New York Heart Association grade ≥3, history of clinically significant (i.e., active) atherosclerotic cardiovascular disease (myocardial infarction, unstable angina, cerebrovascular accident within 6 months prior to the first dose of study treatments).
  • Patients with Dihydropyrimidine Dehydrogenase (DPD) enzyme deficiencies (uracilemia ≥ 16 ng/mL).
  • Immunotherapy within 3 months before the beginning of the treatment study.
Show all 22Show fewer
  • Patient under treatment by strong CYP3A4 inducers.
  • Patients treated by brivudine within 4 weeks before the first dose of study treatment, or concomitant treatment with brivudine.
  • Patient with potentially serious infection.
  • Administration of live or live attenuated vaccine within 30 days prior to the first dose of study treatment start.
  • Poor nutritional state (albuminemia < 25 g/L or weight loss > 10% during the last month).
  • Hereditary problems of galactose intolerance, total lactase deficiency or glucose galactose malabsorption.
  • Other malignancy within 2 years prior to study enrolment, except for localized cancer in situ, basal or squamous cell skin cancer adequately treated.
  • Less than 4 weeks from major surgeries and not recovered adequately from the procedure and/or any complications from the surgery.
  • Patients with persistent toxicities related to prior treatment of grade greater than 1.Is c urrently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks or 5 half-lives (whichever longer) before study entry.
  • Hypersensitivity to one of the active substances or to one of the excipients of the trial treatments.
  • Patient with interstitial lung disease or pulmonary fibrosis.
  • Patients with history of interstitial pneumonitis or pulmonary fibrosis.
  • Has a known psychiatric or substance abuse disorder that would interfere with the patient's ability to cooperate with the requirements of the study.
  • Patient who is under judicial protection and patient who is legally institutionalized or under guardianship or not able to give consent.
  • Pregnant or breastfeeding woman.
  • Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons.

Trial locations and contacts

80 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

80 sites in 4 countries

France50 sites

  • ICO site Paul Papin

    Angers

    Victor SIMMET, 02.41.35.27.39, victor.simmet@ico.unicancer.fr

  • Centre Hospitalier Annecy Genevois

    Annecy

    Emmanuel MAILLARD, 04 50 63 66 05, emaillard@ch-annecygenevois.fr

  • Hôpital Privé

    Antony

    Anne THIROT-BIDAULT, 01 46 74 41 73, a.t.bidault@gmail.com

  • Centre Hospitalier

    Aurillac

    Daniela BURLACU, 04 71 46 47 41, d.burlacu@ch-aurillac.fr

  • Centre Hospitalier

    Bayeux

    Annie PEYTIER, 02 31 51 54 17, a.peytier@ch-ab.fr

  • Ch Cote Basque

    Bayonne

    Franck AUDEMAR, 0559443722, faudemar@ch-cotebasque.fr

  • Ch Simone Veille

    Beauvais

    Hanifa AMMARGUELLAT, 03 44 11 22 16, h.ammarguellat@ch-beauvais.fr

  • Chu Jean Minjoz

    Besançon

    Angélique VIENOT, 03 81 66 83 41, angelique.vienot@gmail.com

  • Centre Hospitalier Béthune Beuvry

    Béthune

    Hélène VAN DAMME, 03 21 64 43 19, helene.vandamme@ch-bethune.fr

  • Polyclinique Courlancy

    Bezannes

    William MINA, 0326840284, wmina@centre-icone.fr

  • Bordeaux Nord Aquitaine

    Bordeaux

    Cédric LECAIL, 0556690681, lecail@hotmail.com

  • TIVOLI

    Bordeaux

    Valérie COCHIN, 05 56 69 06 71, v.cochin@tivoli-oncologie.fr

  • Chu Morvan

    Brest

    Pierre Guillaume POUREAU, 02 30 33 80 40, pgpoureau@gmail.com

  • CHU Côte de Nacre

    Caen

    François JUILLARD, 0231063106, fjuillard7@gmail.com

  • Centre Hospitalier

    Cholet

    Thomas DAVIEU, 0241498491, thomas.davieau@ch-cholet.fr

  • Hôpitaux civils

    Colmar

    Rémi DARRIUS, 03-89-12-46-19, remi.darrius@gmail.com

  • Polyclinique Saint-Côme

    Compiègne

    Kaïs ALDABBAGH, 03 44 92 43 53, kais.aldabbagh@stcome.com

  • Chu Francois Mitterand

    Dijon

    Côme LEPAGE, 03 80 29 37 50, come.lepage@u-bourgogne.fr

  • Gf Leclerc

    Dijon

    Leila BENGRINE LEFEVRE, 03 80 73 75 06, lbengrine@cgfl.fr

  • Institut de cancérologie de Bourgogne GRReCC

    Dijon

    Antoine DROUILLARD, 03 80 67 30 10, adrouillard@icb-cancer.fr

  • Groupe Hospitalier Mutualiste

    Grenoble

    Hélène FLESCH, 04 76 70 73 33, helene.flesch@avec.fr

  • Chd Vendee

    La Roche-sur-Yon

    Margot LALY, 02 51 44 61 68, margot.laly@ght85.fr

  • Hôpital Franco Britannique

    Levallois-Perret

    Benoist CHIBAUDEL, 01 47 59 19 24, benoist.chibaudel@ihfb.org

  • Hôpital Privé Le Bois

    Lille

    Côme DE METZ, 02 20 00 97 57, come_de_metz@hotmail.fr

  • CHU Dupuytren

    Limoges

    Clémentine PEYRAMAURE, 05 55 05 61 00, clementine.peyramaure@chu-limoges.fr

  • Groupe Hospitalier Bretagne Sud

    Lorient

    Caroline COUFFON, 02 97 06 74 55, c.couffon@ghbs.bzh

  • Hôpital Jean Mermoz

    Lyon

    Jérôme DESRAME, 04 37 53 87 26, jerome.desrame@orange.fr

  • Chu La Timone

    Marseille

    Laetitia DAHAN, 0491386023, laetitia.dahan@ap-hm.fr

  • Hôpital Européen

    Marseille

    Nicolas BARRIERE, 04 13 42 77 13, n_barriere@yahoo.fr

  • CHRU

    Nancy

    Marie MULLER, 03 83 59 84 13, m.muller7@chru-nancy.fr

  • Gh Nord Essone

    Orsay

    Manal AWAD, 01 64 54 29 41, m.awad@gh-nord-essonne.fr

  • Chu Cochin

    Paris

    Romain CORIAT, 01 58 41 29 61, romain.coriat@aphp.fr

  • HEGP

    Paris

    Julien TAIEB, 01 56 09 35 51, julien.taieb@aphp.fr

  • Montsouris

    Paris

    Emilie SOULARUE, 01 45 21 37 20, emilie.soularue@imm.fr

  • Saint-Louis

    Paris

    Thomas APARICIO, 01 42 49 95 97, thomas.aparicio@aphp.fr

  • Centre Hospitalier

    Pau

    Juliette THAURY, 05 59 92 49 83, juliette.thaury@ch-pau.fr

  • CHU Haut Leveque

    Pessac

    Denis SMITH, 05 57 65 64 39, denis.smith@chu-bordeaux.fr

  • Centre Cario

    Plérin

    Jérôme MARTIN-BABAU, 02 96 75 22 16, j.martin@cario-sante.fr

  • Chu La Miletrie

    Poitiers

    David TOUGERON, 05 49 44 37 51, david.tougeron@chu-poitiers.fr

    David TOUGERON

  • CH Quimper Concarneau

    Quimper

    Karine BIDEAU, 0290944117, karinebideau@orange.fr

  • Cac Jean Godinot

    Reims

    Damien BOTSEN, 03 26 78 71 70, dbotsen@chu-reims.fr

  • Chu Robert Debré

    Reims

    Olivier BOUCHÉ, 03 26 78 31 13, obouche@chu-reims.fr

  • Centre Hospitalier

    Saint-Denis

    Gaëtan DES GUETZ, 0555055555, gaetan.desguetz@ch-stdenis.fr

  • Hôpital Privé

    Saint-Grégoire

    Edith CARTON, 02 90 09 44 66, edith.carton@icrb.fr

  • Hia Begin

    Saint-Mandé

    Julie LAVOLE, 01.43.98.47.22, julie.lavole@intradef.gouv.fr

  • Groupe Hospitalier Rance Emeraude

    St-Malo

    Anne-Sophie MOUSSADDAQ, 06 15 64 89 56, anne72m@gmail.com

  • Clinique Sainte-Anne

    Strasbourg

    Louis-Marie DOURTHE, 0388453750, lm.dourthe@solcrr.org

  • ICANS

    Strasbourg

    Meher BEN ABDELGHANI, 03 88 25 24 85, m.ben-abdelghani@icans.eu

  • CHRU Trousseau

    Tours

    Romain CHAUTARD, 02 47 47 75 78, romain.chautard@gmail.com

  • Hôpital Nord Ouest

    Villefranche-sur-Saône

    Jonathan OLESINSKI, 04 74 09 67 94, jolesinski@hno.fr

Other trials in France

Italy17 sites

  • Centro Di Riferimento Oncologico Di Aviano

    Aviano

    Luisa FOLTRAN

  • Azienda Ospedaliero Universitaria Policlinico Rodolico San Marco Di Catania

    Catania

    Giuseppe NOVELLO

  • Azienda Ospedaliero Universitaria Careggi

    Florence

    Lorenzo ANTONUZZO

  • Azienda Unita Sanitaria Locale 6 Livorno

    Livorno

    Giacomo ALLEGRINI

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori

    Meldola

    Alessandro PASSARDI

  • Fondazione IRCCS Istituto Nazionale Dei Tumori

    Milan

    Filippo PIETRANTONIO

  • Azienda Ospedaliero-Universitatia Di Cagliari

    Monserrato

    Mario SCARTOZZI

  • Istituto Oncologico Veneto

    Padova

    Francesca BERGAMO

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa

    Roberto MORETTO

  • Azienda USL Toscana Centro

    Prato

    Samantha DI DONATO

  • Azienda Unita Sanitaria Locale Della Romagna

    Ravenna

    Stefano TAMBERI

  • Azienda Ospedaliera Policlinico Universitario Tor Vergata

    Roma

    Vincenzo FORMICA

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma

    Lisa SALVATORE

  • Casa Sollievo Della Sofferenza

    San Giovanni Rotondo

    Tiziana PIA LATIANO

  • Azienda Ospedaliero-Universitaria Città della salute e della scienza di Torino Presidio Molinette

    Torino

    Massimo DI MAIO

  • Pia Fondazione Di Culto E Religione Card Panico

    Tricase

    Emiliano TAMBURINI

  • Azienda Sanitaria Universitaria Friuli Centrale

    Udine

    Valentina FANOTTO

Other trials in Italy

Spain9 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona

    Marta RODRIGUEZ CASTELLS, +34932744350, martarodriguez@vhio.net

  • Hospital Universitario Reina Sofia

    Córdoba

    Gema Guadalupe Pulido, +34957010380, gemapulido.gp@gmail.com

  • Instituto Catalan de Oncologia. Hospital Duran i Reynals

    L'Hospitalet de Llobregat

    Cristina Santos Farre, +34932607136, csantos@iconcologia.net

  • Hospital Universitario Gregorio Maranon

    Madrid

    Pilar Garcia Alfonso, +34914269070, pgarcaalfonso@gmail.com

  • Hospital Universitario Central de Asturias

    Oviedo

    Paula JIMENEZ-FONSECA, +34913788275, ttd@ttdgroup.org

  • Hospital Universitario de Navarra

    Pamplona

    Ruth Vera Garcia, +34848422222, ruth.vera.garcia@navarra.es

  • Hospital Clinico Universitario de Salamanca

    Salamanca

    Maria del Rosario Vidal Tocino

  • Hospital Universitario Clinico San Carlos

    San Carlos

    Javier Sastre Valera

  • Consorcio Hospital General Universitario de Valencia

    Valencia

    Maria José Safont Aguilera, +34963187527, mjsafont@yahoo.es

Other trials in Spain

Germany4 sites

  • Saint Joseph Hospital Bochum

    Bochum

    Anke REINACHER -SCHICK, +49 (0)234/509-3591, onkologie@klinikum-bochum.de

  • Krankenhaus Nordwest-CH Frankfurt Am Main

    Frankfurt

    Oliver GOTZE Thorsten, +49 (069) 76 01-44 20

  • Universitätsmedizin Göttingen CHU

    Göttingen

    Ute Margarethe KONIG

  • Hämatologisch Onkologische Praxis Eppendorf

    Hamburg

    Alexander STEIN, +49 40 36 03522-0, stein@hope-hamburg.de

Other trials in Germany

About this study

Official title: COLOSOTO: Single-arm Phase II Study Evaluating 5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doublet/Triplet Chemotherapy With Advanced Unresectab

5-fluorouracil (5-FU) is a standard of care in frail/elderly patients with an unresectable colorectal adenocarcinoma (CRC) in first-line setting. Panitumumab plus Sotorasib are promising in advanced line in KRAS G12C mutated CRC. In this study, We assess the safety and efficacy of 5FU combination with Panitumumab and Sotorasib as first-line treatment in frail/elderly patients with unresectable KRAS G12C mutated CRC

Read the detailed description

COLOSOTO is a multicenter, open-label, prospective single-arm phase II trial, sponsored and cordinated by the Fédération Francophone de Cancérologie Digestive (FFCD) in collaboration with the ENGIC group (European Network in GastroIntestinal Cancer), evaluating 5-FU plus Panitumumab and Sotorasib as first line treatment in patients with MSS/pMMR KRAS G12C mutated unresectable CRC. Inclusion will begin in September 2025, for 36 months. Overall, patients from 40 European sites will be included (in France, Germany, Italy and Spain).

The main inclusion and exclusion criteria are summarized in Table 1. Main inclusion criteria are patients ≥18 years old, with unresectable MSS/pMMR KRASG12C metastatic CRC histologically proven, with altered WHO Performance Status...

Eligible patients will receive LV5FU2 (a 400mg/m2 intravenous (IV) bolus of 5-FU at day 1 (D1) with 400mg/m2 of folinic acid, followed by a continuous 5-FU infusion of 2400mg/m2 over 46 hours) plus Panitumumab (6mg/kg IV at D1) and Sotorasib (960mg PO once daily, every day) in 2-week-cycles (Q2W) until progression or intolerance (cf Figure 1).

Adverse events requiring dose adjustment or treatment discontinuation will all be assessed using the NCI-CTCAE v5.0 scale and manage in accordance with the standard guidelines and the "Summaries of Product Characteristics".

The primary objective is to evaluate the progression-free survival (PFS) of 5FU plus Panitumumab and Sotorasib at 8 months in first-line treatment of patients non-eligible for a doublet/triplet chemotherapy with advanced unresectable KRAS G12C mutated CRC. The progression will be defined as the radiological progression according to RECIST v1.1 criteria assessed by the investigator. A centralized review of CT-scans will be performed to confirm RECIST 1.1 criteria.

Secondary objectives include median progression-free survival (mPFS), disease control rate (DCR), time to progression (TTP), overall survival (OS), best objective response rate (ORR), duration of response (DoR), safety profile, Quality of life (QoL) (with EORTC QLQC30 and FACIT-GP5 questionnaires), and Geriatric assessment (based on G8 score and " Geriatric COre Data sEt " (G-CODE)).

Toxicity will all be evaluated according to the National cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.0) scale. A safety analysis will be done when 10 patients have been treated for at least 2 months to check the good tolerability of 5-FU plus Panitumumab and Sotorasib combination

Being tested
Administration of experimental treatment association (sotorasib, panitumumab 5FU)
Keywords
sotorasib, colorectal cancer, KRAS G12C
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Administration of experimental treatment association (sotorasib, panitumumab 5FU)Drug

    Panitumumab is administered at a dose of 6 mg/kg via intravenous infusion over one hour during the first cycle, and over 30 minutes from the second cycle onward. The LV5FU2 regimen includes folinic acid (400 mg/m², or 200 mg/m² if levo-leucovorin is used) as a two-hour IV infusion, followed by a 5-FU bolus (400 mg/m² over 10 minutes), and a continuous 5-FU infusion (2400 mg/m² over 46 hours). Sotorasib is given orally at a dose of 960 mg once daily on a continuous basis.

Study groups in NCT07124884
Study groupRoleWhat they receive
5-fluorouracil plus Panitumumab and SotorasibExperimentalEach patient receives one treatment cycle every two weeks until disease progression or unacceptable toxicity. Panitumumab is administered at a dose of 6 mg/kg via intravenous infusion over one hour during the first cycle, and over 30 minutes from the second cycle onward. The LV5FU2 regimen includes folinic acid (400 mg/m², or 200 mg/m² if levo-leucovorin is used) as a two-hour IV infusion, followed by a 5-FU bolus (400 mg/m² over 10 minutes), and a continuous 5-FU infusion (2400 mg/m² over 46 hours). Sotorasib is given orally at a dose of 960 mg once daily on a continuous basis.
Receives: Drug: Administration of experimental treatment association (sotorasib, panitumumab 5FU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patient alive or without progression 8 months after inclusion.

    Progression will be assessed by the investigator according to recist 1.1 based on images performed every 8 weeks even in case of deferred treatments.

    Clinical progression will not be considered as an event.

    Measured: at 8 months after the inclusion.

Secondary outcomes (1)

  1. Overall survival (OS)

    Overall survival was defined as the time from the date of inclusion to the patient's death (all causes). For alive patients, the date of the latest news was taken into account.

    Measured: up to 2 years after inclusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2025
  2. Study start31 Aug 2025 (estimated)
  3. Primary completion30 Jun 2030 (estimated)
  4. Study completion30 Dec 2030 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07124884
Sponsor's protocol ID
PRODIGE 107-ENGIC01-COLOSOTO
Other IDs
2024-514030-20-00
Acronym
COLOSOTO
Status last verified
Aug 2025
First submitted
8 Aug 2025
Last updated
15 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Administration of experimental treatment association (sotorasib, panitumumab 5FU) in people with Colorectal Carcinoma and KRAS G12C Mutation, run by Federation Francophone de Cancerologie Digestive at 80 sites in 4 countries.

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 22 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: opening soon, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in France, Italy, Spain, Germany. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patient alive or without progression 8 months after inclusion. (time frame: at 8 months after the inclusion.). 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 NCT07124884.

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 15 Aug 2025.

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