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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (Complete and Partial Response)