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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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
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 moreSide effects data
From 2021 Phase 1 & 2 trial • 24 Patients • NCT0301035865%
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
13,717 Previous Clinical Trials
40,953,341 Total Patients Enrolled
Keith C BiblePrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
206 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses that my doctor says are not under control.My heart condition severely limits my daily activities.I am currently breastfeeding.I am of childbearing age and do not plan to use birth control.I am immunocompromised due to conditions other than corticosteroid use, including HIV.My cancer has spread, cannot be surgically removed, and standard treatments have failed.My blood clotting time is normal and I'm not on warfarin.My INR level is between 2.0 and 3.0 while on warfarin.My brain metastases have been stable for over 6 months without seizures or steroids.I can take care of myself and am up and about more than half of my waking hours.I haven't had biologic therapy in the last 28 days.I had radiation therapy less than 28 days ago.I have had a heart attack in the last 6 months or have heart failure needing constant treatment.I have high cholesterol.I haven't had chemotherapy in the last 28 days.I haven't taken Mitomycin C or nitrosoureas in the last 42 days.There is a known treatment for my condition that could cure me or extend my life.I have moderate to severe numbness or pain in my hands or feet.I am not taking strong medication that affects liver enzymes or it can be changed.My triglyceride levels are high.I have not had immunotherapy in the last 28 days.I still have side effects from my last chemotherapy.I am not currently on any experimental treatments.I have had no more than two treatments for my cancer after it spread, except for hormone therapy.More than a quarter of my bone marrow has been exposed to radiation.I am not on any experimental drugs for my cancer.My cancer can be monitored but not measured.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ixabepilone, temsirolimus)
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