Pancreatic CancerPhase 3NCT07409272
A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer
A Phase 3 study testing Setidegrasib, Oxaliplatin and Leucovorin in people with Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Astellas Pharma Global Development, Inc. at 79 sites in 6 countries.
Trial summary
Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- Setidegrasib, Oxaliplatin and Leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 614 participants
- Where
- 79 sitesin 6 countries
- Study dates
- 17 Feb 2026to 31 Aug 2029
- Phase
- Phase 3
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
- Participant has histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC) with documented Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation based on local or central testing (confirmation of a participant's positive KRAS G12D mutation result must be available prior to randomization).
- Participant has no option for surgical resection or radiotherapy with curative intent.
- Participant consents to and provides a baseline tumor tissue specimen for the study during screening. The sample must meet the requirements described in the laboratory manual and the tumor sample guidance.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 within 7 days prior to randomization.
- Participant has adequate organ function as indicated by the following laboratory values within 7 days prior to randomization (if a participant has received a recent blood transfusion, the latest laboratory tests must be obtained ≥ 14 days after any blood transfusion). The laboratory values prior to the initiation of the first dose of setidegrasib/placebo (or mFOLFIRINOX/NALIRIFOX, if chemotherapy is administered during the screening period) should be used to determine eligibility. Participants who receive mFOLFIRINOX/NALIRIFOX during the screening period must meet these criteria within 7 days prior to the start of on-treatment chemotherapy (i.e., C1D1).
- Participant agrees not to participate in another interventional study while receiving study intervention in the present study (participant who is currently in the follow-up period of an interventional clinical trial is allowed).
Who cannot join
- Participant has neuroendocrine, acinar pancreatic carcinoma or pancreatic cancer with squamous/adenosquamous features.
- Participant has another prior malignancy active (i.e., requiring treatment, including hormonal therapies, or intervention) within the previous 2 years different from the primary malignancy for this study, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed.
- Participant has chronic inflammatory bowel disease, bowel obstruction and/or severe uncontrolled diarrhea.
- Participant has peripheral sensory neuropathy with functional impairment.
- Participant has ascites and/or pleural effusion that require invasive interventions within 30 days prior to randomization or have an indwelling drainage catheter.
- Participant has symptomatic pulmonary embolism or pulmonary embolism not being treated with anticoagulation.
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- Participant has a history of interstitial lung disease or pulmonary fibrosis.
- Participant has uncontrolled seizure disorder or refractory to antiepileptics.
- Participant has known homozygous uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphism.
- Participant has had a myocardial infarction, unstable angina or coronary artery bypass surgery within 6 months prior to randomization or currently has an uncontrolled illness including but not limited to symptomatic congestive heart failure, clinically significant cardiac disease (e.g., cardiomyopathy, infiltrative cardiac disease, etc.), unstable angina pectoris, cardiac arrhythmia, obligate use of a cardiac pacemaker or long QT interval (QT) syndrome.
- Participant has received any prior systemic therapy for their metastatic PDAC (except with up to 2 doses [i.e., 28 days; 1 cycle] of mFOLFIRINOX or NALIRIFOX during the screening period. If a participant received [neo]adjuvant chemotherapy, tumor recurrence or disease progression must have occurred ≥ 6 months after completing the last dose of the [neo]adjuvant therapy).
- Participant has had prior treatment with a KRAS G12D-targeted agent.
- Participant has a corrected QT interval by Fridericia (QTcF) (single electrocardiogram [ECG]) > 470 msec during the screening period.
Trial locations and contacts
79 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
79 sites in 6 countries
United States49 sites, 49 recruiting
- Recruiting
University of Michigan Health - University of Michigan Medical Center
Ann Arbor, Michigan, 48109
- Recruiting
Piedmont Healthcare - Piedmont Physicians Medical Oncology Atlanta
Atlanta, Georgia, 30318
- Recruiting
University of Maryland School - Division of Hematology/Oncology
Baltimore, Maryland, 21201
- Recruiting
Memorial Sloan Kettering - Hackensack - Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
- Recruiting
Saint Joseph Hospital - Cancer Centers - St. Vincent Frontier Cancer Center
Billings, Montana, 59102
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
- Recruiting
UVA Emily Couric Cancer Center
Charlottesville, Virginia, 22903
- Recruiting
Facilities Design and Construction - Energy Advancement and Innovation Center
Columbus, Ohio, 43210
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
- Recruiting
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
- Recruiting
Saint Elizabeth Medical Center, Inc. DBA St. Elizabeth Health Care
Edgewood, Kentucky, 41017
- Recruiting
Inova Schar Cancer Institute Clinical Trials
Fairfax, Virginia, 22031
- Recruiting
Mercy Cancer Center
Fort Smith, Arkansas, 72903
- Recruiting
Crosson Cancer Institute at Providence St. Jude Medical Center in Fullerton
Fullerton, California, 92835
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
- Recruiting
Hartford Healthcare
Hartford, Connecticut, 06016
- Recruiting
Houston Methodist Office of Graduate - Houston Methodist Neal Cancer Center at Texas Medical Center
Houston, Texas, 77030
- Recruiting
Indiana University Health - Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
- Recruiting
UCI Health - Irvine
Irvine, California, 92612
- Recruiting
Baptist MD Anderson Cancer Institute
Jacksonville, Florida, 32207
- Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
- Recruiting
Cedars-Sinai - Cedars-Sinai Medical Center
Los Angeles, California, 90048
- Recruiting
Baptist Health Medical Group Oncology
Miami, Florida, 33176
- Recruiting
Mount Sinai Medical Center - Miami Beach
Miami Beach, Florida, 33140
- Recruiting
Memorial Sloan Kettering Cancer Center - Monmouth
Middletown, New Jersey, 00748-3052
- Recruiting
NYU Long Island Mineola
Mineola, New York, 11501
- Recruiting
Allina Health Cancer Institute - Hematology Cancer Care Services
Minneapolis, Minnesota, 55407
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
- Recruiting
Atlantic Health - Overlook Medical Center
Morristown, New Jersey, 07962
- Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
- Recruiting
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065
- Recruiting
Hoag Mem Hosp Presbyterian
Newport Beach, California, 92663
- Recruiting
Mercy Hospital Oklahoma City - Mercy Coletta Cancer Center - Oklahoma City
Oklahoma City, Oklahoma, 73120
- Recruiting
UC Irvine Health-Chao Family Comprehensive Cancer Center
Orange, California, 92868-3201
- Recruiting
AGH Singer Research Institute
Pittsburgh, Pennsylvania, 15212
- Recruiting
Oregon Health & Science University - OHSU Knight Cancer Institute
Portland, Oregon, 97201
- Recruiting
Brown University Health Cancer Institute - Division of Hematology/Oncology
Providence, Rhode Island, 02906
- Recruiting
University of Rochester
Rochester, New York, 14611
- Recruiting
HealthPartners Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426
- Recruiting
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota, 55101
- Recruiting
Utah Cancer Specialists
Salt Lake City, Utah, 84106
- Recruiting
Virginia Mason Franciscan Health - Virginia Mason Medical Center
Seattle, Washington, 98101
- Recruiting
Fred Hutchinson Cancer Center - Advanced Cancer Research Group
Seattle, Washington, 98109
- Recruiting
Mercy CH Chub O'Reilly Cancer Center
Springfield, Missouri, 65804
- Recruiting
The Alvin J. Siteman Cancer Center - Center for Advanced Med
St Louis, Missouri, 63110
- Recruiting
Mercy David C. Pratt Cancer Center - St. - Mercy Research - David C. Pratt Cancer Center
St Louis, Missouri, 63141
- Recruiting
University of Arizona Cancer Center - North Campus
Tucson, Arizona, 85719
- Recruiting
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
- Recruiting
White Plains Hospital Center for Cancer Care - Oncology
White Plains, New York, 10601
Japan12 sites, 12 recruiting
- Recruiting
The University of Tokyo Hospital
Bunkyo-ku, Tokyo
- Recruiting
Kyushu Group - Kyushu Cancer Center
Fukuoka, Fukuoka
- Recruiting
Nara Medical University Hospital
Kashihara-shi, Nara
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba
- Recruiting
Japanese Foundation for Cancer Research - The Cancer Institute Hospital of JFCR
Koto, Tokyo
- Recruiting
Chugoku-Shikoku Group - Shikoku Cancer Center
Matsuyama, Ehime
- Recruiting
Aichi Cancer Center
Nagoya
- Recruiting
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
Osaka
- Recruiting
Kindai University Hospital
Sakai, Osaka
- Recruiting
The University of Osaka Hospital
Suita, Osaka
- Recruiting
Keio University Hospital
Tokyo
- Recruiting
Yamaguchi University Hospital
Ube-shi, Yamaguchi
South Korea8 sites, 8 recruiting
- Recruiting
Site KR82004
Cheongju-si
- Recruiting
Site KR82015
Incheon
- Recruiting
Site KR82006
Seongnam-si
- Recruiting
Site KR82002
Seoul
- Recruiting
Site KR82010
Seoul
- Recruiting
Site KR82012
Seoul
- Recruiting
Site KR82013
Seoul
- Recruiting
Site KR82014
Suwon
United Kingdom7 sites, 7 recruiting
- Recruiting
Site GB44001
Cambridge
- Recruiting
Site GB44007
Cottingham
- Recruiting
Site GB44010
Ipswich
- Recruiting
Site GB44019
London
- Recruiting
Site GB44032
London
- Recruiting
Site GB44031
Maidstone
- Recruiting
Site GB44020
Sutton
Taiwan2 sites, 2 recruiting
- Recruiting
Site TW88603
Taichung
- Recruiting
Site TW88605
Taipei
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center - Xuhui Campus
Shanghai, Shanghai Municipality
About this study
Official title: A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination With mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants With KRAS G12D Mutated Metastatic Pancreatic Adenocarcinoma
Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer. The first treatment that people usually receive is chemotherapy. At the time this study started, some of the main standard chemotherapies for pancreatic cancer were mFOLFIRINOX or NALIRIFOX.
Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Many people with pancreatic cancer have a faulty KRAS gene. One such change in the KRAS gene is called a G12D mutation. Researchers are looking for ways to stop the actions of abnormal proteins made from the KRAS G12D mutation.
Read more
This study is about setidegrasib given with chemotherapy in people with pancreatic cancer who have the KRAS G12D mutation. Before setidegrasib can become an approved treatment, clinical studies need to be completed to understand how it works and how safe it is.
The main aim is to learn if people who are given setidegrasib with chemotherapy live for longer than people who are given placebo with chemotherapy. Other aims are to learn if setidegrasib delays the cancer and symptoms returning, how the body processes setidegrasib, and its safety, when given with chemotherapy.
People in this study will be adults with metastatic pancreatic cancer with the G12D mutation in their KRAS gene. Surgery or radiotherapy will not be an option to cure their cancer.
People cannot take part if the cancer cells have spread to the thin tissue covering the brain and spinal cord (leptomeningeal disease), have symptoms of cancer in the brain or nervous system, or have recently had some other cancers that required treatment.
In this study, people are given either setidegrasib with mFOLFIRINOX or NALIRIFOX chemotherapy, or a placebo with mFOLFIRINOX or NALIRIFOX chemotherapy. Whether people receive setidegrasib or placebo is decided by chance. The study doctor decides which chemotherapy (mFOLFIRINOX or NALIRIFOX) people receive. People will only receive NALIRIFOX chemotherapy (with setidegrasib or placebo) after the safety of setidegrasib with NALIRIFOX chemotherapy has been confirmed in another ongoing setidegrasib study. All of the study treatments are given slowly through a tube into a vein (infusion). People will continue to receive study treatment until their cancer gets worse, they can't tolerate the study treatment, they start other cancer treatment, they or the doctor decides the person should stop receiving study treatment, or sadly they pass away. There will be safety checks at each visit, and the doctors will continue to check for medical problems and people's wellbeing throughout the study.
- Being tested
- Setidegrasib, Oxaliplatin, Leucovorin, Irinotecan, fluorouracil
- Keywords
- Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma, ASP3082, setidegrasib, KRAS G12D, PDAC, mFOLFIRINOX, NALIRIFOX
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SetidegrasibDrug
Also called ASP3082
Intravenous infusion
OxaliplatinDrug
Intravenous infusion
LeucovorinDrug
Also called folinic acid, levofolinate
Intravenous infusion
IrinotecanDrug
Intravenous infusion
fluorouracilDrug
Also called 5-FU
Intravenous infusion
liposomal irinotecanDrug
Intravenous infusion
PlaceboDrug
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| Setidegrasib plus chemotherapy | Experimental | Participants will receive setidegrasib once weekly plus mFOLFIRINOX (oxaliplatin, leucovorin [folinic acid or levofolinate], irinotecan and 5-FU) or NALIRIFOX (liposomal irinotecan, oxaliplatin, leucovorin [or levofolinate] and 5 FU) chemotherapy on a 28-day cycle. Receives: Drug: Setidegrasib; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Irinotecan; Drug: fluorouracil; Drug: liposomal irinotecan |
| Placebo plus chemotherapy | Placebo comparator | Participants will receive placebo once weekly plus mFOLFIRINOX (oxaliplatin, leucovorin [folinic acid or levofolinate], irinotecan and 5-FU) or NALIRIFOX (liposomal irinotecan, oxaliplatin, leucovorin [or levofolinate] and 5 FU) chemotherapy on a 28-day cycle. Receives: Drug: Oxaliplatin; Drug: Leucovorin; Drug: Irinotecan; Drug: fluorouracil; Drug: liposomal irinotecan; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as the time from the date of randomization until the date of death from any cause.
Measured: Up to 3.5 years
Secondary outcomes (17)
Progression-Free Survival (PFS) per RECIST v1.1. as assessed by the investigator.
PFS is defined as the time from the start of randomization until the date of documented radiological disease progression per RECIST v1.1 as assessed by the investigator or until death for any cause, whichever comes first.
Measured: Up to 3.5 years
Time to Improvement in Pancreatic Pain (TIPP) measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-PAN26).
EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms.
Measured: Up to 3.5 years
Time to Worsening of General Health Status/Quality of Life (GHS/QoL) (TWGQ) measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms.
Measured: Up to 3.5 years
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1,
ORR is defined as the proportion of participants whose best overall response is rated as complete response (CR) or partial response (PR) per RECIST v1.1. as assessed by the investigator.
Measured: Up to 3.5 years
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to 3.5 years
Number of Participants with Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and other medically important events.
Measured: Up to 3.5 years
Number of Participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Measured: Up to 3.5 years
Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs.
Number of participants with potentially clinically significant ECG values.
Measured: Up to 3.5 years
Number of Participants with vital sign abnormalities and/or AEs.
Number of participants with potentially clinically significant vital sign values.
Measured: Up to 3.5 years
Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status.
The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
Measured: Up to 3.5 years
Pharmacokinetics (PK) of setidegrasib End-of-Infusion (EOI) concentration
EOI Concentration will be recorded from plasma samples collected.
Measured: Up to 9 months
PK of setidegrasib in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough)
Ctrough will be recorded from plasma samples collected.
Measured: Up to 9 months
Change from baseline in EORTC QLQ-PAN26
EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms.
Measured: Up to 3.5 years
Change from baseline in EORTC QLQ-C30
The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms.
Measured: Up to 3.5 years
Change from baseline in EuroQol 5-dimensional 5-level version (EQ-5D-5L)
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome consisting of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale for health status. Each domain comprises 5 severity levels (no problems, slight problems, moderate problems, severe problems, extreme problems). The general visual analog scale records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples.
Measured: Up to 3.5 years
Change from baseline in Patient Global Impression of Change (PGIC).
The PGIC is a single-item questionnaire that asks participants to provide the overall self-assessment of change in their disease on a 7-point scale ranging from "very much worse" to "very much better" as compared to the participant starting the study treatment. Only PGIC questions assessing pain and overall status will be collected.
Measured: Up to 3.5 years
Change from baseline in Patient Global Impression of Severity PGIS
The PGIS is a single-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week, with 1 as "None" and 4 as "Severe". Only PGIS questions assessing pain and overall status will be collected.
Measured: Up to 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start17 Feb 2026
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 614 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409272
- Sponsor's protocol ID
- 3082-CL-0301
- Status last verified
- Sep 2026
- First submitted
- 9 Feb 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.