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Anti-tumor antibiotic

Ixazomib + Gemcitabine + Doxorubicin for Bladder Cancer

Phase 1 & 2

Waitlist Available

Led By Arlene O Siefker-Radtke

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Are surgically sterile, OR

Are postmenopausal for at least 1 year before the screening visit, OR

Must not have

Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities

Ongoing or active systemic infection, known active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to treat urothelial cancer. Ixazomib citrate, gemcitabine hydrochloride, and doxorubicin hydrochloride will be given to see what side effects occur and what the best dose is.

Who is the study for?

This trial is for adults with urothelial cancer that has spread or can't be removed by surgery. They must have had at least one prior therapy, unless they cannot or refuse cisplatin-based therapy. Participants should not be pregnant, breastfeeding, or planning to become pregnant and must agree to use effective contraception. They need a certain level of heart, liver, and kidney function and cannot have severe heart disease, active infections like hepatitis B/C or HIV, unstable angina, significant neuropathy (nerve pain), recent major surgery or other clinical trials within the last month.

What is being tested?

The trial tests ixazomib citrate combined with chemotherapy drugs gemcitabine hydrochloride and doxorubicin hydrochloride on patients with advanced urothelial cancer. It aims to find the best dose while assessing how well this combination works in stopping tumor growth compared to current treatments.

What are the potential side effects?

Potential side effects include reactions related to organ inflammation such as fatigue; blood disorders; increased risk of infection; nausea; hair loss from chemotherapy drugs gemcitabine and doxorubicin; plus possible nerve damage from ixazomib citrate.

Eligibility Criteria

Inclusion Criteria

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

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I am surgically sterile.

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I have been postmenopausal for at least one year.

Exclusion Criteria

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

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I haven't had a heart attack in the last 6 months and don't have severe heart issues.

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I do not have an active infection, hepatitis B or C, or HIV.

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I have severe nerve damage in my hands or feet, or moderate with pain.

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I am currently pregnant or breastfeeding.

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I have symptoms of heart failure.

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I have recovered from previous chemotherapy with minimal side effects.

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I have unstable chest pain.

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I haven't taken specific strong medications or herbal supplements in the last 14 days.

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I have had a stroke or mini-stroke in the past year.

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My kidney function, measured by creatinine clearance, is below 30 mL/min.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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 (ixazomib, gemcitabine, doxorubicin)Experimental Treatment3 Interventions

Patients receive ixazomib citrate PO, gemcitabine hydrochloride IV over 90 minutes, and doxorubicin hydrochloride IV over 15-30 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine Hydrochloride

2005

Completed Phase 3

~5420

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17860