Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed locally advanced or metastatic solid tumor that is
refractory to standard therapy or for which no standard therapy exists

- Progressed after first-line and second-line therapy (if there is a second-line
therapy that has been shown to provide clinical benefit)

- Must receive standard second-line therapy if second-line therapy has been
shown to provide clinical benefit

- Evaluable disease by physical examination, imaging, and/or one of the following:

- Two rising prostate-specific antigen (PSA) levels ≥ 2 weeks apart, with one
obtained during screening (for patients with prostate cancer)

- Two rising CA-125 levels ≥ 2 weeks apart, with one obtained during screening
(for patients with ovarian cancer)

- No CNS cancer, either primary lesions or metastatic disease, as the current
malignancy

- No pleural effusions, ascites, or leptomeningeal disease as the only manifestation of
the current malignancy

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Granulocyte count ≥ 1,500/μL

- Platelet count ≥ 100,000/μL

- Hemoglobin ≥ 9 g/dL

- Serum bilirubin normal

- Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN) (≤ 4 times ULN for
patients with liver or bone metastases)

- AST and ALT ≤ 1.5 times ULN (≤ 5 times the ULN for patients with liver metastases)

- Serum creatinine ≤ 1.5 mg/dL

- INR < 1.3

- aPTT ≤ 1.5 times ULN

- Fasting total serum cholesterol ≤ 220 mg/dL (without cholesterol-lowering drugs)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able and willing to swallow pills

- No malabsorption syndrome or other condition that would interfere with enteral
absorption

- No history of significant atherosclerotic disease, including the following:

- Coronary artery disease (i.e., myocardial infarction within the past year or
unstable angina)

- Documented carotid atheromas

- No history of congestive heart failure or ventricular arrhythmia requiring medication

- No congenital long QT syndrome

- No baseline QTc intervals > 0.47 seconds on two of three baseline 12-lead ECGs
recorded during the screening period

- No active infection requiring intravenous antibiotics

- No known HIV infection

- No uncontrolled hypocalcemia, hypomagnesemia, or hypokalemia, defined as less than
the lower limit of normal for the institution despite adequate electrolyte
supplementation

- No history of clinically important liver disease, including cirrhosis or viral or
other hepatitis

- No current alcohol abuse

- No significant traumatic injury within the past 3 weeks

- No other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the study results or renders the patient at high risk from
treatment complications

PRIOR CONCURRENT THERAPY:

- At least 4 weeks since prior chemotherapy, investigational therapy, radiotherapy, or
major surgical procedure and recovered

- No concurrent medications with narrow therapeutic indices that are cytochrome P450
substrates (warfarin sodium [Coumadin®])

- No concurrent medications known to prolong the QT interval, including any of the
following:

- Quinidine or other anti-arrhythmic agents

- Haloperidol, fluoxetine, paroxetine, or sertraline

- Pentamidine, fluoroquinolone, or macrolide antibiotics

- No concurrent medications that may interfere with the metabolism of GDC-0449 (e.g.,
ketoconazole)

- No concurrent grapefruit juice