Saracatinib in Treating Patients With Relapsed or Refractory Thymoma or Thymic Cancer (NCT00718809) | Clinical Trial Compass
TerminatedPhase 2
Saracatinib in Treating Patients With Relapsed or Refractory Thymoma or Thymic Cancer
United States21 participantsStarted 2008-06
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Objective Response Rate (Complete and Partial Response)