Status:
COMPLETED
Erlotinib for Chemoprevention in Trisomy 7 Positive Primary Sclerosing Cholangitis (PSC)
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Primary Sclerosing Cholangitis
Trisomy 7
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Primary sclerosing cholangitis (PSC) is a chronic inflammatory condition of the bile ducts of unknown etiology. It is characterized by diffuse inflammation and stricturing of the entire biliary tree, ...
Eligibility Criteria
Inclusion
- Male or female patients \> 18 years of age, able to provide written informed consent.
- Diagnosis of Primary Sclerosing Cholangitis.
- Scheduled for an ERCP as part of their clinical care.
- Diagnosed with trisomy 7 on cytologic testing.
- Willingness to utilize adequate contraception (if female, evidenced by being postmenopausal for at least 6 months or using contraceptive pill; for both females and males, being surgically sterile, or using two forms of barrier contraception) from screening to at least one month after the trial.
Exclusion
- Cholangiocarcinoma, hepatocellular carcinoma, pancreatic adenocarcinoma or other malignancy \<=3 years of registration.
- Other liver disease as determined by standard clinical, serological, imaging or histological criteria.
- Secondary cause of sclerosing cholangitis (IgG cholangiopathy, autoimmune, post-surgical biliary stricture, radiation, human immunodeficiency syndrome).
- Cholestasis with a bilirubin of \> 1.6 mg/dl (normal range: 0.1 - 1.0 mg/dL).
- Decompensated cirrhosis, Child-Pugh Class B or C.
- Child A cirrhosis with portal hypertension (i.e., splenomegaly, esophageal or gastric varices, or platelet count \< 100,000/µl \[normal range: 150 - 450 x 103/µL\]).
- Transaminase (AST \[norm.: 8-48 U/L\], ALT \[norm.: 7-55 U/L\]) elevation of more than three times the upper limit of the normal range.
- Pregnancy.
- Nursing mothers.
- Uncontrolled intercurrent illness.
- Concurrent administration of CYP3A modulators, Antiepileptics, Rifampin, St. Johns wort, Ketoconazole, protonpump-inhibitors.
- Men or women unwilling to employ adequate contraception.
- Abnormalities of the cornea by history.
- Moderate diarrhea defined as defecation frequency of equal or more than 4/d for those with their colon, equal or more than 8/d for patients with a pouch, and high ostomy output with those with ostomy.
- Known interstitial lung disease
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00955149
Start Date
August 1 2009
End Date
April 1 2013
Last Update
January 10 2014
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905