Sirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed By Surgery (NCT01791088) | Clinical Trial Compass
CompletedPhase 1
Sirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed By Surgery
United States56 participantsStarted 2012-06-13
Plain-language summary
This clinical trial studies sirolimus in treating patients with solid tumors that are metastatic or cannot be removed by surgery. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Who can participate
Age range12 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 or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
* Weight \>= 40 kg
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
* Life expectancy \> 3 months
* Absolute neutrophil count (ANC) \>= l500/ul
* Hemoglobin \>= 9g/dL
* Platelets \>= 100,000/ ul
* Total bilirubin \< 1.5 x upper limit of normal
* Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate transaminase (SGPT) \< 2.5 x upper limit of normal for patients without liver metastases OR SGOT and SGPT \< 5 x upper limit of normal for patients with liver metastases
* Measurable or non-measurable disease will be allowed
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, up until 30 days after final study treatment; should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately
* Patients taking substrates, inhibitors, or inducers of cytochrome P450 (CYP)3A4 should be encouraged to switch to alternative drugs whenever possible, given the potential for drug-drug interactions with sirolimus
* Signed informed consent
Exclusion Criteria:
* Prior treatment with a mammalian target of rapamycin (mTO…
What they're measuring
1
Change in fasting glucose and fasting triglycerides
Timeframe: Baseline to 8 days
2
Change in fasting glucose and fasting triglycerides
Timeframe: Baseline to 15 days
3
Change in fasting glucose and fasting triglycerides