New drug cocktail targets advanced cancers in early trial
NCT ID NCT01087554
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This Phase I trial tests the safety and best dose of combining vorinostat with one of three mTOR inhibitors (sirolimus, everolimus, or temsirolimus) in up to 249 patients with advanced cancer that has not responded to standard treatments. The drugs aim to block cancer cell growth and division. The study is active but no longer recruiting, and will also measure tumor response as a secondary goal.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mTOR inhibitors (sirolimus, everolimus, temsirolimus) combined with vorinostat
- What this could lead to
- If successful, this could identify a tolerable drug combination that shrinks tumors or slows cancer growth in patients who have run out of standard options.
- What could go wrong
- This is an early Phase I trial focused on safety and dosing, not effectiveness. The combination may cause significant side effects or fail to control the cancer. Results may not apply to all cancer types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 249 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2010
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients must have a histologically-confirmed metastatic or locally advanced cancer that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy that increases survival by at least three months does not exist 2. There is no limit on the number of prior treatment regimens 3. Patients must be off prior cytotoxic chemotherapy for at least three weeks. For biologic or targeted therapy, there should be five half lives or three weeks, whichever is shorter, between their last treatment and the first dose on this trial. 4. Patients may receive palliative radiation therapy before or during treatment on protocol, provided that there is measurable or evaluable disease out of the radiation field. Patients may receive palliative radiation therapy, if needed, 48 hours after last dose of investigational drug. In addition patients may be enrolled on trial seven days following palliative radiation. We will closely monitor for the appearance of radiation recall reactions. Hormonal therapy may continue in patients who have been on such treatment for three months or longer. 5. ECOG performance status 0-3 6. Patients must have adequate organ and marrow function as defined by: absolute neutrophil count \>/= 1000uL, platelets \>/= 50,000uL, bilirubin \</=2mg/dL (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome), ALT \</= 2 x ULN or \</=5x ULN if liver metastases present, creatinine \</= 2mg/dL 7. As the effect of sirolimus or everolimus or temsirolimus and vorinostat in combination on the developing human fetus is not known, women of child-bearing potential and men must agree to use adequate contraception (abstinence; hormonal or barrier method of birth control) for the study and at least 3 months after completion 8. Female patients with child-bearing potential must have a negative serum or urine pregnancy test within 7 days of study enrollment. Nursing mothers should discontinue nursing 9. Ability to understand and the willingness to sign a written informed consent document 10. Measurable or evaluable disease 11. Patient must be able to swallow pills Exclusion Criteria: 1. Myocardial infarction within 3 months prior to starting treatment 2. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital or St. Johns wort, cyclosporine, diltiazem, ketoconazole should be discontinued if possible. The list of CYP3A4 inhibitors: http://medicine.iupui.edu/clinpharm/ddis/clinical-table/ 3. Patient has a known hypersensitivity to the components of study drugs, its analogues, or drugs of similar chemical or biologic composition 4. Patient is pregnant or breastfeeding 5. Major surgical procedure within 28 days of day 1 of therapy 6. Use of any other concurrent investigational agents or anticancer agents except for hormonal therapy as outlined in inclusion criteria
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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