AzTrials
AzTrials

HRAS Gene MutationPhase 2AIM-HN/SEQ-HNNCT03719690

Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy

A Phase 2 study testing Tipifarnib and HRAS Detection Assay in people with HRAS Gene Mutation and HNSCC, run by Kura Oncology, Inc. at 102 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HRAS Gene Mutation, HNSCC
What is being tested?
Tipifarnib and HRAS Detection Assay
Could I receive a placebo?
No, everyone receives an active treatment
How many people
296 participants
Where
102 sitesin 16 countries
Study dates
15 Mar 2019to 2 May 2023
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

  • AIM-HN
  • At least 18 years of age.
  • Histologically confirmed head and neck cancer (oral cavity, pharynx, larynx, sinonasal, nasopharyngeal, or unknown primary) of squamous histology not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
  • Documented treatment failure from most recent prior therapy (e.g. tumor progression, clinical deterioration, or recurrence), and from at least one prior platinum-containing regimen, in any treatment setting.
  • Known tumor missense HRAS mutation.
  • Measurable disease by RECIST v1.1.
Show all 14Show fewer
  • ECOG performance status of 0-1.
  • Acceptable liver, renal and hematological function
  • Other protocol defined inclusion criteria may apply.
  • At least 18 years of age.
  • Histologically confirmed head and neck cancer (oral cavity, pharynx, larynx, sinonasal, nasopharyngeal, or unknown primary) of squamous histology.
  • Will or has received at least one systemic anti-cancer therapy for recurrent or metastatic HNSCC.
  • HRAS wildtype (i.e., have no identified tumor missense HRAS mutation).
  • Other protocol defined inclusion criteria may apply

Who cannot join

  • Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma).
  • Received treatment for unstable angina within prior year, myocardial infarction within the prior year, cerebro-vascular attack within the prior year, history of New York Heart Association grade III or greater congestive heart failure, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
  • Non-tolerable Grade 2 or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.
  • Active, uncontrolled bacterial, viral or fungal infections requiring systemic therapy. Known history of infection with human immunodeficiency virus or an active infection with hepatitis B or hepatitis C.
  • Received treatment for non-cancer related liver disease within prior year.
  • Other protocol defined exclusion criteria may apply
  • 1. Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma).
  • 5. Other protocol defined exclusion criteria may apply

Trial locations and contacts

102 sites in 16 countries.

102 sites in 16 countries

United States29 sites

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Marlene and Stewart Greenebaum Cancer Center

    Baltimore, Maryland, 21287

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Chicago

    Chicago, Illinois, 60637

  • The Ohio State University

    Columbus, Ohio, 43210

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • San Antonio Military Medical Center

    Fort Sam Houston, Texas, 78234

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky, 40536

  • University of Southern California Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • UCLA - Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Vanderbilt University Medical Center-Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232

  • New York University Langone Medical Center

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Texas Health San Antonio - Mays Cancer Center

    San Antonio, Texas, 78229

  • UCSF - Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Siteman Cancer Center - Washington University Medical Campus

    St Louis, Missouri, 63129

  • University of South Florida H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • University Of Kansas Medical Center

    Westwood, Kansas, 66205

  • The Oncology Institute of Hope and Innovation - Anaheim

    Whittier, California, 90603

Other trials in United States

Spain15 sites

  • Hospital del Mar - Parc de Salut Mar

    Barcelona, 08003

  • Hospital de la Santa Creu i de Sant Pau

    Barcelona, 08025

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Duran i Reynals

    Barcelona, 08908

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • HM Centro Integral Oncológico Clara Campal

    Madrid, 28050

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Costa Del Sol

    Marbella, 29603

  • Complejo Hospitalario de Navarra

    Pamplona, 31008

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, 15707

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Taiwan9 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • Chang Gung Medical Foundation Keelung Chang Gung Memorial Hospital

    Keelung, 20442

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Cheng Kung University Hospital

    Tainan, 70403

  • Mackay Memorial Hospital

    Taipei, 10099

  • National Taiwan University Hospital

    Taipei, 100

  • Chang Gung Memorial Hospital

    Taoyuan, 33305

Other trials in Taiwan

South Korea8 sites

  • National Cancer Center

    Goyang-si, 10408

  • Chonbuk National University Hospital

    Jeonju, 54907

  • Korea University Anam Hospital

    Seoul, 02841

  • Yonsei University Health System Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea - Seoul St. Mary's Hospital

    Seoul, 06591

  • The Catholic University of Korea St. Vincent's Hospital

    Suwon, 16247

Other trials in South Korea

Italy7 sites

  • Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi

    Bologna, 40138

  • Azienda Ospedaliera S. Croce e Carle Cuneo

    Cuneo, 12100

  • Ospedale Mater Salutis di Legnago

    Legnago, 37045

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

  • Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano

    Milan, 20133

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, 80131

  • Azienda Ospedaliera Universitaria Senese-L'ospedale Santa Maria alle Scotte

    Siena, 53100

Other trials in Italy

United Kingdom6 sites

  • NHS Greater Glasgow and Clyde

    Glasgow, G12 0XH

  • Guy's and Saint Thomas' NHS Foundation Trust

    London, England, SE1 9RT

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2BU

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT

Other trials in United Kingdom

Belgium5 sites

  • Ziekenhuis Netwerk Antwerpen Middelheim

    Antwerp, 2020

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

  • Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne

    Yvoir, Namur, 5530

Other trials in Belgium

Germany4 sites

  • Charité Universitätsmedizin Berlin

    Berlin, 12203

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Universitätsmedizin Mannheim

    Mannheim, 68167

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

Greece3 sites

  • University General Hospital of Athens Attikon

    Chaïdári, 12462

  • University General Hospital of Larissa

    Larissa, 41110

  • Bioclinic - Thessaloniki

    Thessaloniki, 54622

Other trials in Greece

Netherlands3 sites

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Maastricht University Medical Centre

    Maastricht, 6229 HX

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Thailand3 sites

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

  • Songklanagarind Hospital

    Hat Yai, 90110

Other trials in Thailand

Australia2 sites

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

  • Royal North Shore Hospital

    Saint Leonards, 2065

Other trials in Australia

Austria2 sites

  • Allgemeines Krankenhaus der Stadt Wien

    Vienna, 1090

  • Hanusch Krankenhaus Wiener Gebietskrankenkasse

    Vienna, 1140

Other trials in Austria

Denmark2 sites

  • Rigshospitalet

    Copenhagen, 2100

  • Herlev Hospital

    Herlev, 2730

Other trials in Denmark

Malaysia2 sites

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Institut Kanser Negara

    Putrajaya, 62250

Other trials in Malaysia

Norway2 sites

  • Haukeland Universitetssjukehus

    Bergen, 1521

  • Radiumhospitalet

    Oslo, 0379

Other trials in Norway

About this study

Official title: A 2 Cohort, Non-comparative, Pivotal Study Evaluating the Efficacy of Tipifarnib in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC) With HRAS Mutations (AIM-HN) and the Impact of HRAS Mutations on Response to First Line Systemic Therapies for HNSCC (SEQ-HN)

An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, SEQ-HN, is an observational sub-study including HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.

Read the detailed description

KO-TIP-007 is an international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN) and the impact of HRAS mutations on response to first line systemic therapies for HNSCC (SEQ-HN). KO-TIP-007 has 2 study cohorts. The first study cohort, named AIM-HN, includes HNSCC subjects with HRAS mutations. AIM-HN subjects will receive treatment with tipifarnib and the outcome of this cohort will be evaluated for ORR by an independent review facility.

The second study cohort, SEQ-HN, is an observational sub-study including HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.

HNSCC patients in whom HRAS mutations are identified and who meet eligibility criteria will be offered participation in AIM-HN. HNSCC patients in whom HRAS mutations are not identified may participate in SEQ-HN only. These patients will be followed and the comparison of outcomes of HRAS mutant and HRAS wild type HNSCC will address the exploratory objective to determine the effect of HRAS mutation on the ORR of first line systemic therapy in patients with recurrent/metastatic HNSCC. Outcome data from subsequent lines of therapy will be collected.

Being tested
Tipifarnib, HRAS Detection Assay
Keywords
TIPIFARNIB, HEAD AND NECK CANCER
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

What participants receive

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

  • TipifarnibDrug

    Tablet for oral administration

  • HRAS Detection AssayDevice

    In Vitro Assay to detect HRAS mutations

Study groups in NCT03719690
Study groupRoleWhat they receive
AIM-HNExperimentalTipifarnib, Oral Tablet. Dose Level 1 orally, bid on days 1-7 and 15-21 of 28-day treatment cycles
Receives: Drug: Tipifarnib; Device: HRAS Detection Assay
SEQ-HNNo interventionHNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.

What is being measured

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

  1. Objective Response Rate (ORR) in High Variable Allele Frequency (VAF) Population, as Assessed by Independent Review Facility (IRF)

    ORR was defined as the percentage of participants who experienced a best overall response (BOR) of complete response (CR; disappearance of all target lesions) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by IRF. 95% confidence interval (CI) was calculated by the exact binomial (Clopper-Pearson) method.

    Measured: Up to approximately 28 months

Secondary outcomes (16)

  1. ORR in All VAF Population, as Assessed by IRF

    ORR was defined as the percentage of participants who experienced a BOR of CR or PR and was assessed using RECIST v1.1 by IRF. 95% CI was calculated by the exact binomial (Clopper-Pearson) method.

    Measured: Up to approximately 28 months

  2. Duration of Response (DoR) in High VAF Population, as Assessed by IRF

    DoR was defined as the time from the date of first response (CR or PR [whichever occurred first]) to the date of progression of disease or death of any cause, whichever occurred first, in participants with a confirmed CR or PR and was assessed using RECIST v1.1 by IRF. Median was calculated using the Kaplan-Meier method. 95% CI was based on Brookmeyer and Crowley method with log-log transformation.

    Measured: Up to approximately 28 months

  3. DoR in All VAF Population, as Assessed by IRF

    DoR was defined as the time from the date of first response (CR or PR [whichever occurred first]) to the date of progression of disease or death of any cause, whichever occurred first, in participants with a confirmed CR or PR and was assessed using RECIST v1.1 by IRF. Median was calculated using the Kaplan-Meier method. 95% CI was based on Brookmeyer and Crowley method with log-log transformation.

    Measured: Up to approximately 28 months

  4. Progression Free Survival (PFS) in High VAF Population, as Assessed by IRF

    PFS was defined as months from the first dose of the study drug to the first documented progressive disease (PD, appearance of one or more new lesions or at least a 20% increase in the sum of the diameters of target lesions) or death, whichever came first and was assessed using RECIST v1.1 by IRF. Median was calculated using the Kaplan-Meier method. 95% CI was based on Brookmeyer and Crowley method with log-log transformation.

    Measured: Up to approximately 28 months

  5. PFS in All VAF Population, as Assessed by IRF

    PFS was defined as months from the first dose of the study drug to the first documented PD or death, whichever came first and was assessed using RECIST v1.1 by IRF. Median was calculated using the Kaplan-Meier method. 95% CI was based on Brookmeyer and Crowley method with log-log transformation.

    Measured: Up to 28 approximately months

  6. PFS Rate in High VAF Population, as Assessed by IRF

    PFS rate was defined as the percentage of participants who had not experienced documented PD or death, whichever came first and was assessed using RECIST v1.1 by IRF at 6 and 9 month timepoints. Percentage of participants was calculated using the Kaplan-Meier method. 95% CI was calculated using normal approximation to the log transformed cumulative hazard rate

    Measured: 6 months and 9 months

  7. PFS Rate in All VAF Population, as Assessed by IRF

    PFS rate was defined as the percentage of participants who had not experienced documented PD or death, whichever came first and was assessed using RECIST v1.1 by IRF at 6 and 9 month timepoints. Percentage of participants was calculated using the Kaplan-Meier method. 95% CI was calculated using normal approximation to the log transformed cumulative hazard rate.

    Measured: 6 months and 9 months

  8. Overall Survival (OS) in High VAF Population

    OS was defined as months from first dose date until death from any cause. Median was calculated using the Kaplan-Meier method. 95% CI was based on Brookmeyer and Crowley method with log-log transformation.

    Measured: Up to approximately 28 months

  9. OS in All VAF Population

    OS was defined as months from first dose date until death from any cause. Median was calculated using the Kaplan-Meier method. 95% CI was based on Brookmeyer and Crowley method with log-log transformation.

    Measured: Up to approximately 28 months

  10. OS Rate at 12 Months in High VAF Population

    OS rate was defined as the percentage of participants who had not experienced or death and was assessed at 12 months. Percentage of participants was calculated using the Kaplan-Meier method. 95% CI was calculated using normal approximation to the log transformed cumulative hazard rate.

    Measured: 12 months

  11. OS Rate at 12 Months in All VAF Population

    OS rate was defined as the percentage of participants who had not experienced or death and was assessed at 12 months. Percentage of participants was calculated using the Kaplan-Meier method. 95% CI was calculated using normal approximation to the log transformed cumulative hazard rate.

    Measured: 12 months

  12. Time to Response (TTR) in High VAF Population, as Assessed by IRF

    TTR was defined as months from treatment start to first CR or PR (whichever was first recorded) in participants with confirmed CR or PR and was assessed using RECIST v1.1 by IRF. TTR was summarized descriptively by summary statistics.

    Measured: Up to approximately 28 months

  13. TTR in All VAF Population, as Assessed by IRF

    TTR was defined as months from treatment start to first CR or PR (whichever was first recorded) in participants with confirmed CR or PR and was assessed using RECIST v1.1 by IRF. TTR was summarized descriptively by summary statistics.

    Measured: Up to approximately 28 months

  14. Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)

    TEAEs were defined as adverse events (AEs) that started on or after the first dose of the study drug and within 30 days of the last administration of the study drug. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 was used for toxicity grading (Grade 3: severe or disabling; Grade 4: life-threatening; Grade 5: death related to AE). Clinically significant changes in laboratory tests, vital signs, and electrocardiogram results were reported as AEs.

    Measured: Up to approximately 28 months

  15. Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module 35 (EORTC QLQ-H&N35) Subscales

    Change from Baseline score in pain, swallowing, speech problems, and senses problems subscales of EORTC QLQ-H\&N35 are summarized individually. Raw scores for each subscale were linear transformations and standardized to range (0 - 100), with higher scores representing worse levels of symptoms. Change from Baseline was calculated as End of Treatment Observed - Baseline with a negative change representing a reduction in symptoms.

    Measured: Baseline and End of Treatment Visit (up to approximately 28 months)

  16. Change From Baseline in the EuroQol-Visual Analog Scale (EQ-VAS) Score

    The EQ-VAS forms part of the EQ-5D-5L and collects the self-rating health status from 0 (the worst imaginable health) to 100 (the best imaginable health). Change from Baseline was calculated as End of Treatment Observed - Baseline with a negative change representing an increase in symptoms.

    Measured: Baseline and End of Treatment Visit (up to approximately 28 months)

Timeline

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

  1. First posted25 Oct 2018
  2. Study start15 Mar 2019
  3. Primary completion2 May 2023
  4. Study completion2 May 2023

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
296 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03719690
Sponsor's protocol ID
KO-TIP-007
Acronym
AIM-HN/SEQ-HN
Status last verified
May 2024
First submitted
16 Oct 2018
Last updated
21 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tipifarnib and HRAS Detection Assay in people with HRAS Gene Mutation and HNSCC, run by Kura Oncology, Inc. at 102 sites in 16 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 8 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 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in United States, Spain, Taiwan, South Korea, Italy and 11 more countries. 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 21 Jun 2024). 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?

Objective Response Rate (ORR) in High Variable Allele Frequency (VAF) Population, as Assessed by Independent Review Facility (IRF) (time frame: Up to approximately 28 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 NCT03719690.

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 21 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in