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Microtubule Inhibitor

Ixabepilone + Temsirolimus for Advanced Cancer

Phase 1

Waitlist Available

Led By Keith C Bible

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

International normalized ratio (INR) =< 1.4 for patients not on warfarin (Coumadin)

Must not have

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

New York Heart Association classification III or IV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing ixabepilone and temsirolimus to see if they are effective and have manageable side effects in treating patients with solid tumors.

Who is the study for?

This trial is for adults with solid tumors that have spread or can't be surgically removed, and who've had no more than two treatments for metastatic disease. They must have adequate blood counts, liver and kidney function, not be pregnant or nursing, able to consent, and willing to use contraception. Excluded are those recently treated with chemotherapy or radiation, with severe heart conditions or other serious illnesses that could affect the study's safety assessment.

What is being tested?

The trial tests the combination of ixabepilone (a chemotherapy drug) and temsirolimus (an enzyme blocker) on patients with advanced solid tumors. It aims to find the safest doses while observing how well these drugs work together in stopping tumor growth by killing cancer cells or preventing them from dividing and spreading.

What are the potential side effects?

Potential side effects include reactions at the infusion site, fatigue, changes in blood counts leading to increased infection risk or bleeding problems, liver issues indicated by altered lab values, kidney function changes measured by creatinine levels in blood tests; also possible are digestive disturbances like nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread, cannot be surgically removed, and standard treatments have failed.

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My blood clotting time is normal and I'm not on warfarin.

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My INR level is between 2.0 and 3.0 while on warfarin.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses that my doctor says are not under control.

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My heart condition severely limits my daily activities.

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I am currently breastfeeding.

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I am of childbearing age and do not plan to use birth control.

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I am immunocompromised due to conditions other than corticosteroid use, including HIV.

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I haven't had biologic therapy in the last 28 days.

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I have had a heart attack in the last 6 months or have heart failure needing constant treatment.

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I have high cholesterol.

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I haven't had chemotherapy in the last 28 days.

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I haven't taken Mitomycin C or nitrosoureas in the last 42 days.

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There is a known treatment for my condition that could cure me or extend my life.

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I have moderate to severe numbness or pain in my hands or feet.

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My triglyceride levels are high.

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I have not had immunotherapy in the last 28 days.

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I still have side effects from my last chemotherapy.

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I am not currently on any experimental treatments.

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More than a quarter of my bone marrow has been exposed to radiation.

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I am not on any experimental drugs for my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

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

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

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358

33%

Infusion Related Reaction

33%

Alanine aminotransferase increased

33%

Aspartate aminotransferase increased

33%

Neutrophil count decreased

17%

Sinusitis

17%

Tumor Lysis Syndrome

17%

Interoperative Hemorrhage

17%

Platelet count decreased

17%

Febrile neutropenia

17%

Infusion related reaction

17%

Upper respiratory infection

17%

Otitis externa

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1, Dose 1 (400 mg Entospletinib Daily)

Phase 2 and MTD (800 mg Entospletinib Daily)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ixabepilone, temsirolimus)Experimental Treatment3 Interventions

Patients 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temsirolimus

2008

Completed Phase 2

~1940

Ixabepilone

2006

Completed Phase 3

~2270