Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lisa Bax
With
Roche Pharma AG
Genentech, Inc.
Please contact Principal Investigators team for full details.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documented tissue diagnosis of pancreatic ductal adenocarcinoma with a sufficient amount of tissue for Laser Capture Micro-dissection (LCM) of the stromal and tumour compartments.
Confirmed eligibility for a Whipple's or distal pancreatectomy procedure by Multi-Disciplinary Team (MDT) and surgeon review.
Adequate organ function defined as:
* Creatinine clearance ≥ 50ml/min (as defined by Cockcroft-Gault)
* Electrolytes (Sodium (Na)/Potassium (K)/Calcium (Ca)) within institutional normal limits
World Health Organization (WHO) performance status 0-1
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Males should not donate sperm during treatment or up to 3 months after the last dose.
Women of childbearing potential are required to have a negative serum pregnancy test (with sensitivity of at least 25 mIU/mL) within 10-14 days and within 24 hours prior to the first dose of GDC-0449.
You may not be if
Known Hepatitis B/C or Human Immunodeficiency Virus (HIV) infection
Known hypersensitivity to GDC-0449
Active cardiac ischemic disease (this criterion only applies for participation in the imaging part of the study)
Women, who are pregnant plan to become pregnant or are lactating (during the study or for up to 12 months after the last dose).
Concurrent participation in another clinical trial using an investigational medicinal product.
Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or in the judgment of the investigator would make it undesirable for the patient to enter the trial (i.e. patients is not able to swallow tablets).
Clareo Health | Hedgehog Inhibition for Pancreatic Ductal Adenocarcinoma (PDAC) in the Preoperative Setting (HIPPoS)
