Trial studying safety and effects for Pancreatic Cancer
Official title A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer
ClinicalTrials.gov ID: NCT07409272
What this study is testing
What is Setidegrasib?
an investigational intravenous medicine being studied as a possible treatment for pancreatic cancer with a KRAS G12D mutation
Also referred to as ASP3082.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if adding the drug setidegrasib to standard chemotherapy helps people live longer than chemotherapy alone. It also checks for safety and how the body handles the drug.
- Who it's for
- Adults with metastatic pancreatic cancer that has a specific KRAS G12D gene change, where surgery or radiation is not an option.
- What's involved
- Participants receive either setidegrasib or a placebo (sugar pill) along with standard chemotherapy. All treatments are given through a tube into a vein.
- Time commitment
- Treatment continues until the cancer grows, side effects become too hard to manage, or the person chooses to stop.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant has histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC) with documented Kirsten rat sarcoma viral oncogene...
- 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.
- 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...
You likely can't join if
- 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...
- 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...
- Participant has symptomatic pulmonary embolism or pulmonary embolism not being treated with anticoagulation.
See the full eligibility criteria
- 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...
- 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...
- Participant agrees not to participate in another treatment study while receiving study intervention in the present study (participant who is currently in the follow-up period of an treatment clinical trial is allowed).
- 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...
- 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.
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Gilbert, Arizona, United States
- Tucson, Arizona, United States
- Fort Smith, Arkansas, United States
- Fullerton, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Orange, California, United States
- Hartford, Connecticut, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Miami Beach, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Edgewood, Kentucky, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
+ 75 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Gilbert, Arizona, United States; Tucson, Arizona, United States; Fort Smith, Arkansas, United States; Fullerton, California, United States; Irvine, California, United States; Los Angeles, California, United States and 89 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.