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Adult Solid NeoplasmPhase 1NCT01375829

Ixabepilone and Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

A Phase 1 study testing Ixabepilone, Pharmacological Study and Temsirolimus in people with Adult Solid Neoplasm, run by National Cancer Institute (NCI) at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase I trial studies the side effects and best dose of ixabepilone and temsirolimus in treating patients with solid tumors that have spread from the primary site to other places in the body or cannot be removed by surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adult Solid Neoplasm
What is being tested?
Ixabepilone, Pharmacological Study and Temsirolimus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
2 sitesUnited States
Study dates
27 Jun 2011to 19 Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Phase I Study of Ixabepilone and Temsirolimus in Adult Patients With Advanced Solid Tumors

This phase I trial studies the side effects and best dose of ixabepilone and temsirolimus in treating patients with solid tumors that have spread from the primary site to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ixabepilone together with temsirolimus may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximally tolerated dose (MTD) of the combination of ixabepilone and temsirolimus in patients with advanced solid tumors.

II. To describe toxicity profiles associated with the combination of ixabepilone and temsirolimus.

III. To assess preliminary efficacy of the combination of ixabepilone and temsirolimus.

OUTLINE: This is a dose-escalation study.

Patients receive ixabepilone intravenously (IV) over 3 hours on day 1 and temsirolimus IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 3 months.

Being tested
Ixabepilone, Pharmacological Study, Temsirolimus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IxabepiloneDrug

    Also called (1S,3S,7S,10R,11S,12S,16R)-7,11-Dihydroxy-8,8,10,12,16-pentamethyl-3-[(1E)-1-methyl-2-(2-methyl-4-thiazolyl)ethenyl]-17-oxa-4-azabicyclo[14.1.0]heptadecane-5,9-dione, Azaepothilone B, BMS 247550, BMS-247550

    Given IV

  • Pharmacological StudyOther

    Correlative studies

  • TemsirolimusDrug

    Also called CCI 779, CCI-779, CCI-779 Rapamycin Analog, CCI779

    Given IV

Study groups in NCT01375829
Study groupRoleWhat they receive
Treatment (ixabepilone, temsirolimus)ExperimentalPatients receive ixabepilone IV over 3 hours on day 1 and temsirolimus IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Ixabepilone; Other: Pharmacological Study; Drug: Temsirolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD of the combination of ixabepilone and temsirolimus, defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients)

    Measured: 21 days

Secondary outcomes (8)

  1. Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

    The number and severity of all adverse events (overall, by dose-level, and by tumor group) will be tabulated and summarized in this patient population.

    Measured: Up to 3 months

  2. Incidence of overall toxicity graded according to Common Toxicity Criteria standard grading

    Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.

    Measured: Up to 3 months

  3. Best response, defined to be the best objective status recorded from the start of the treatment until disease progression/recurrence

    Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population (overall and by tumor group).

    Measured: Up to 3 months

  4. Time until any treatment related toxicity

    Measured: Up to 3 months

  5. Time until treatment related grade 3+ toxicity

    Measured: Up to 3 months

  6. Time until hematologic nadirs (white blood cells, absolute neutrophil count, platelets)

    Measured: Up to 3 months

  7. Time to progression

    Measured: Up to 3 months

  8. Time to treatment failure

    Measured: From registration to documentation of progression, unacceptable toxicity, or refusal to continue participation by the patient, assessed up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2011 (estimated)
  2. Study start27 Jun 2011
  3. Primary completion26 Jun 2018
  4. Study completion19 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01375829
Sponsor's protocol ID
NCI-2012-02907
Other IDs
NCI-2012-02907, NCI-2012-01136, CDR0000702380, NCI-2011-01140, MC1013, 8814, P30CA015083, U01CA069912
Status last verified
Sep 2026
First submitted
16 Jun 2011
Last updated
11 Sep 2026
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ixabepilone, Pharmacological Study and Temsirolimus in people with Adult Solid Neoplasm, run by National Cancer Institute (NCI) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD of the combination of ixabepilone and temsirolimus, defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01375829.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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