Saracatinib in Treating Patients With Relapsed or Refractory Thymoma or Thymic Cancer
Condition: Invasive Thymoma and Thymic Carcinoma; Recurrent Thymoma and Thymic Carcinoma; Stage III Thymoma; Stage IVA Thymoma; Stage IVB Thymoma
MeSH terms: Carcinoma; Thymoma; Thymus Neoplasms
Intervention: saracatinib
Intervention description: Given orally
Intervention MeSH terms: Saracatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well saracatinib works in treating patients with relapsed
      or refractory thymoma or thymic cancer. Saracatinib may stop the growth of tumor cells by
      blocking some of the enzymes needed for cell growth
    

Eligibility criteria:

        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