Saracatinib in Treating Patients With Relapsed or Refractory Thymoma or Thymic Cancer

This is an interventional treatment trial for Invasive Thymoma and Thymic Carcinoma Read More

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