Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT01096732
Eligibility Criteria:
Inclusion Criteria:
* 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
* Alanine transaminase (ALT)/Aspartate transaminase (AST) \<5\*ULN
* Partial thromboplastin time (PTT)\<2\*ULN, prior supplementation with vitamin K is allowed
* Adequate blood counts: neutrophils \>1,500/μl, Hb \> 6mmol/L,platelets \>100.000/μl
* Albumin ≥ 25mg/dL
* Written informed consent
* Male or female aged 18 years or over.
* 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.
Exclusion Criteria:
* 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01096732
Study Brief:
Protocol Section:
NCT01096732