Phase II Trial of AZD0530 for Patients With Relapsed/Refractory Thymic Malignancies (Thymoma and Thymic Carcinoma)

Inclusion Criteria:

- Histologically confirmed invasive thymoma or thymic carcinoma, meeting the following
criteria:

- Relapsed or refractory disease

- Metastatic, unresectable disease

- Locally invasive disease allowed provided it is not resectable and has been
previously treated

- Progressive disease

- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by
conventional techniques or >= 10 mm by spiral CT scan

- Must have received >= 1 prior chemotherapy regimen

- No active brain metastases

- Patients with previously treated brain metastases (surgical resection or
radiotherapy) are eligible provided they have documented stable brain disease for >=
1 month after completion of therapy and are asymptomatic

- ECOG performance status 0-2

- Leukocytes >= 3,000/mm^3

- ANC >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Hemoglobin > 9 g/dL

- Serum bilirubin < 2.0 times upper limit of normal (ULN)

- Transaminases =< 2.5 times ULN (< 5.0 times ULN if liver metastasis is present)

- Serum creatinine < 1.5 times ULN OR creatinine clearance > 50 mL/min

- Urine protein:creatinine ratio < 0.5 OR urine protein < 1,000 mg by 24-hour urine
collection

- QTc < 460 msec

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after
completion of study treatment

- No known history of allergic reactions attributed to compounds of similar chemical or
biological composition to AZD0530

- No other malignancies within the past 3 years, except curatively treated in situ
carcinoma of the cervix or completely resected nonmelanoma skin cancer

- No concurrent active malignancies other than thymic malignancy

- No condition that impairs the ability to swallow AZD0350 tablets (e.g.,
gastrointestinal tract disease resulting in an inability to take oral medication or a
requirement for IV alimentation, prior surgical procedures affecting absorption, or
active peptic ulcer disease)

- No cardiac dysfunction including, but not limited to, any of the following:

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- History of ischemic heart disease

- Myocardial infarction within the past year

- No QTc prolongation or other significant ECG abnormalities

- No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 150 mm
Hg or diastolic BP ≥ 95 mm Hg)

- No evidence of severe or uncontrolled systemic conditions that would make it
undesirable to participate in the study or that would jeopardize compliance with the
study, including any of the following:

- Severe hepatic impairment

- Interstitial lung disease (bilateral, diffuse, or parenchymal lung disease)

- Unstable or uncompensated respiratory condition

- Unstable or uncompensated cardiac condition

- No uncontrolled illness including, but not limited to, any of the following:

- Ongoing or active infection

- Mental health issues or social circumstances that would limit compliance with
study requirements

- No prior src inhibitors

- At least 4 weeks since prior systemic therapy (6 weeks for carmustine or mitomycin C)

- At least 8 weeks since prior immunotherapy

- At least 4 weeks since prior octreotide

- Concurrent octreotide for pure red cell aplasia allowed provided patient continues on
the same dose and schedule, has had a response to this drug, and has demonstrated
progressive thymoma by radiography or physical exam

- At least 4 weeks since prior surgery and recovered

- At least 4 weeks since prior investigational agents

- At least 4 weeks since prior radiotherapy to measurable disease sites (2 weeks for
palliative radiotherapy to metastatic sites) and recovered

- At least 7 days since prior and no concurrent active CYP3A4 agents or substances

- No other concurrent investigational or anticancer agents

- No concurrent combination antiretroviral therapy for HIV-positive patients

- Concurrent steroids allowed for treatment of a pre-existing autoimmune disorder or as
antiemetic therapy