New drug combo shows promise for Hard-to-Treat cancers
NCT ID NCT01375829
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
This early-stage trial tested the safety and best dose of two drugs, ixabepilone and temsirolimus, given together to adults with advanced solid tumors that had spread or could not be removed. The goal was to find a dose that limits side effects while potentially killing more cancer cells. A total of 22 participants were enrolled.
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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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22 people
The number who actually took part.
- Started
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Jun 2011
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
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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18 years and older
- 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: * Adult patients with histologically confirmed solid tumor malignancy that is metastatic or unresectable and for which standard curative measures or other therapy that provide survival benefit do not exist or are no longer effective * Patients may not have had more than two systemic therapeutic regimens in the metastatic disease setting with the following exceptions: hormonal therapy (e.g. tamoxifen, aromatase inhibitors, anti-androgen therapy, etc.) * Patients with non-measurable, but assessable, disease will be allowed * Absolute neutrophil count \>= 1500/mcL * Hemoglobin \>= 9.0 g/dL * Platelets \>= 100,000/mcL * Total bilirubin \< 1.5 mg/dL * Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) or serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 2.5 x institutional upper limit of normal (ULN) in the absence of hepatic metastasis; SGPT (ALT) =\< 3 x ULN or SGOT (AST) =\< 5 x ULN in the presence of hepatic metastasis * Creatinine =\< 1.5 x ULN * International normalized ratio (INR) =\< 1.4 for patients not on warfarin (Coumadin) * INR range of 2.0-3.0 for patients on therapeutic doses of warfarin (Coumadin) * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 * Ability to provide informed consent * Willingness to return to a Mayo Clinic institution for follow up * Life expectancy \>= 84 days (12 weeks) * Women of childbearing potential only: negative serum pregnancy test done =\< 7 days prior to registration Exclusion Criteria: * Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes or with hemoglobin A1c (HbA1C) \> 8, or psychiatric illness/social situations that would limit compliance with study requirements * Any of the following prior therapies: * Chemotherapy =\< 28 days prior to registration * Mitomycin C/nitrosoureas =\< 42 days prior to registration * Immunotherapy =\< 28 days prior to registration * Biologic therapy =\< 28 days prior to registration * Radiation therapy =\< 28 days prior to registration * Radiation to \> 25% of bone marrow * Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment * New York Heart Association classification III or IV * Known central nervous system (CNS) metastases or seizure disorder; patients with known brain metastases that have been successfully treated and stable for \> 6 months without requirement for corticosteroids and without seizure activity will be eligible * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation) * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * History of myocardial infarction =\< 168 days (6 months), or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * \>= Grade 2 sensory neuropathy * \>= Grade 2 hypertriglyceridemia * \>= Grade 2 hypercholesterolemia * Patients on medication considered strong cytochrome P450 3A4 (CYP3A4) inducers (efavirenz, nevirapine, carbamazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, St. John's wort) or CYP3A4 inhibitors (indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, telithromycin) unless the medication can be substituted with another agent
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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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Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors