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

Not Recruiting

Trial ID: NCT00718809


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

Official Title

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

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor


Inclusion Criteria:

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

      - 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

   - 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


drug: saracatinib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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