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

Stopped early · Phase 2

Conditions studied: Invasive Thymoma and Thymic Carcinoma, Recurrent Thymoma and Thymic Carcinoma, Stage III Thymoma, Stage IVA Thymoma, Stage IVB Thymoma

In brief

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

Key facts

Study ID

NCT00718809

Run by

National Cancer Institute (NCI)

People needed

21

Starts

2008-06-01

Expected to finish

2013-10-01

Last updated by the study team

2015-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Stanford University Hospitals and Clinics — Stanford, California, United States
• Indiana University Medical Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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