Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Phase II Multicenter Trial Evaluating the Efficacy and Safety of a Systemic Hedgehog Pathway Antagonist (GDC-0449) in Patients With Basal Cell Nevus Syndrome (BCNS)
Brief Summary: The purpose of this study is to reduce the number of new surgically eligible BCCs by 50% appearing during month 3-18 of medication ingestion.


Options:
A: DISEASE CHARACTERISTICS:

* Histologically confirmed primary basal cell skin carcinoma

  * Nodular or superficial lesion(s)\*
  * Located in low-risk areas NOTE: \*Any number of lesions are allowed but only 1 lesion per patient is selected for the study
* No genetic or nevoid conditions (e.g., Gorlin's syndrome)
* No morphoeic (microinfiltrative) histology

PATIENT CHARACTERISTICS:

Age

* Any age

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* No bleeding disorder

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for up to 1 month after study participation
* No allergy to any of the study interventions
* No life-threatening disease
* Must be available for study follow-up for up to 3 years
* Must have access to a telephone

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* No concurrent participation in any other experimental trial
B: Inclusion Criteria:

* Subjects with a clinical diagnosis of a nodular basal cell carcinoma of less than 1 cm, 1 cm away from eye, nose or ears

Exclusion Criteria:

* Subjects of less than 18 years of age
* Subjects unable to comply with instructions,
* Immunosuppressed subjects
C: Inclusion Criteria:

* Patients with locally advanced BCC and metastatic BCC
* Patients with adequate bone marrow, liver, and renal function

Exclusion Criteria:

* Patients who had had major surgery within 4 weeks of initiation of study medication
* Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes.
* Patients with concurrent medical conditions that may interfere or potentially affect the interpretation of the study.
* Patients with neuromuscular disorders or are on concurrent treatment with drugs that may cause muscle damage.
* Patients who were on concurrent therapy with other anti-neoplastic agents.
* Patients who had taken part in an experimental drug within 4 weeks of initiation of study medication.
* Pregnant or nursing (lactating) women
* Women of child bearing potential unwilling to use 2 forms of highly effective contraception throughout the study and for 3 months after the last treatment
* Fertile males not willing to use condoms throughout the study and for 3 months after the last treatment.
* Patients who were unwilling or unable to comply with the protocol.
D: Inclusion Criteria:

The subject:

* has had diagnosed at least 10 SEB (of diameter 3 mm diameter or greater on the nose or periorbital skin, 5 mm or greater elsewhere on the face, or 9 mm or greater on non-facial areas excluding the skin below the knees) during the two years before study entry, as documented histologically in physicians' records and/or diagnosed clinically by a Study Investigator at baseline.
* meet diagnostic criteria for basal cell nevus syndrome
* is willing to abstain from application of non-study topical medications to the skin for the duration of the study, including prescription and over the counter preparations. Subjects will be encouraged to use sunscreen (SPF 15) at least once daily on all exposed skin sites.
* is willing to forego treatment of BCCs unless the BCCs are documented by Study Investigators, preferably on two separate visits, except when the PSCP believes that delay in treatment potentially might compromise the health of the subject.
* has normal laboratory tests as defined by the following: Normal hematopoietic capacity, Normal hepatic function: AST and ALT greater than or equal to 2x the upper limit of normal (ULN) Total bilirubin within normal range 0.20 mg/dl to 1.50 mg/dl or within 3x ULN for patients with Gilbert's disease Normal renal function: normal serum creatinine or measured creatinine clearance less than 50 mL/minute. Fasting cholesterol greater than or equal to 220 untreated
* be willing to not donate blood or semen for three months following discontinuation of Study medications.
* is willing to avoid pregnancy in his partner as defined by the following: Male subject is willing to use a latex condom during the study and for 3 months after the last dose during sexual contact with a female of childbearing potential, even if he has had a successful vasectomy. His partner must also use a form of birth control

Exclusion Criteria:

The subject:

* has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study. Specifically these include the use of: (i) glucocorticoids to more than 5% of the skin (ii) retinoids systemically or topically to more than 5% of the skin during the six months prior to study entry; (iii) alpha-hydroxy acids to more than 5% of the skin during the six months prior to study entry (iv) 5-fluorouracil or imiquimod systemically or topically to the skin above the knees during the six months prior to study entry. (v) treatment with systemic chemotherapy within one year prior to starting study medication.
* has a history of hypersensitivity to any of the ingredients in the study medication formulations.
* is unable to return for follow-up visits and tests.
* has uncontrolled systemic disease, including known HIV positive patients.
* has history of congestive heart failure.
* has uncontrolled hypocalcemia, hypomagnesemia, or hypokalemia
* has clinically important history of liver disease, including viral or hepatitis, current alcohol abuse, or cirrhosis.
* has any condition or situation which in the Investigator's opinion may put the subject at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the study.
* has a history of invasive cancer within the past five years excluding non-melanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or CLL Stage 0.
* has current, recent (within 4 weeks of Day 1), or planned participation in an experimental drug study while enrolled in this study.
* is a female who is pregnant, plans to ever to become pregnant, capable of becoming pregnant or is breast feeding.
* is a male who is unwilling or unable to comply with pregnancy prevention measures.

Answer: D