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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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I have had no more than two treatments for my cancer after it spread, except for hormone therapy.
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My cancer can be monitored but not measured.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)
Secondary outcome measures
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
+5 more

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358
65%
Infusion related reaction
59%
Neutrophil count decreased
41%
Upper respiratory infection
29%
Aspartate aminotransferase increased
29%
Platelet count decreased
24%
Alanine aminotransferase increased
18%
Sinusitis
18%
Urinary tract infection
12%
Tooth infection
6%
Bronchial infection
6%
Acute Coronary Syndrome
6%
Febrile neutropenia
6%
Sepsis
6%
Infections and infestations - Other, specify
6%
Nail infection
6%
Rhinitis infective
6%
Tumor lysis syndrome
6%
Infusion Related Reaction
6%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 and MTD (800 mg Entospletinib Daily)
Phase 1, Dose 1 (400 mg Entospletinib Daily)

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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,624 Total Patients Enrolled
Keith C BiblePrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
206 Total Patients Enrolled

Media Library

Ixabepilone (Microtubule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01375829 — Phase 1
Solid Tumors Clinical Trial 2023: Ixabepilone Highlights & Side Effects. Trial Name: NCT01375829 — Phase 1
Ixabepilone (Microtubule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01375829 — Phase 1
Solid Tumors Research Study Groups: Treatment (ixabepilone, temsirolimus)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks do participants of the Pharmacological Study potentially face?

"There is only limited clinical data attesting to the safety of this pharmacological study, so it received a rating of 1."

Answered by AI

How many participants are receiving care within this trial?

"This clinical trial is not presently enrolling patients. It was originally added to the database on June 27th 2011 and recently modified on September 20th 2022. If you're looking for other active studies, there are 5 trials accepting adult solid-tumor participants and 159 research initiatives recruiting people who want to take part in pharmacological investigations."

Answered by AI

What therapeutic purposes does Pharmacological Study typically serve?

"Pharmacological Study is a common remedy for coughing, along with treating joint discomfort, upper respiratory tract infection and seborrheic dermatitis."

Answered by AI

Are there any other examples of Pharmacological Study being tested in prior clinical studies?

"At present, there are 159 studies running that research Pharmacological Study. Of those active trials, 18 have reached Phase 3. Whilst the majority of Pharmocological Study related investigations originate from Cincinnati, Ohio - 1971 sites worldwide are conducting trials involving this treatment modality."

Answered by AI

Are there any current opportunities for participation in this research?

"Unfortunately, no further participants are being recruited for this study. It was posted on June 27th 2011 and the most recent edit to the protocol occurred on September 20 2022. On the other hand, there are 5 trials currently accepting patients with adult solid neoplasm and 159 studies in which pharmacological research is underway that have opportunities for involvement."

Answered by AI
~2 spots leftby Mar 2025