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Anti-tumor antibiotic

Ixazomib + Chemotherapy for Kidney Cancer

Phase 2

Waitlist Available

Led By Pavlos Msaouel

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

Adolescent patients age 12 years and older with signed assent and parental consent

Absolute neutrophil count >= 1000/uL without growth factor support

Must not have

Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods

Uncontrolled brain or leptomeningeal metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is studying a combination of drugs to treat kidney cancer. Ixazomib may stop the growth of tumor cells by blocking some enzymes needed for cell growth. Gemcitabine and doxorubicin 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.

Who is the study for?

This trial is for patients with advanced or metastatic kidney cancer, including rare types like RMC and rhabdoid tumors. Eligible participants may have had prior treatments but must show disease progression. They need to be over 12 years old, in fairly good health (ECOG 0-2), and meet specific blood count and organ function criteria. Those with controlled brain metastases can join if they meet certain conditions.

What is being tested?

The study tests a combination of ixazomib (which blocks enzymes needed for cell growth) with chemotherapy drugs gemcitabine and doxorubicin on patients with locally advanced or metastatic kidney cancer. The goal is to see if this mix works better than current treatments at stopping tumor growth.

What are the potential side effects?

Potential side effects include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems, liver issues reflected by altered blood tests, heart complications such as reduced heart function, nerve damage presenting as numbness or tingling in extremities.

Eligibility Criteria

Inclusion Criteria

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

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I am 12 or older and have both my agreement and my parents' consent.

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My white blood cell count is healthy without needing medication.

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My kidney tumor is rare, advanced, or has spread, and lacks SMARCB1.

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I have at least one tumor that can be measured.

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I am able to get out of my bed or chair and move around.

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My cancer is advanced or has spread, and tests show a specific protein is missing.

Exclusion Criteria

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

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I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.

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My cancer has spread to my brain or its coverings and is not under control.

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My nerve damage does not severely affect my daily activities.

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I have a stomach or intestine condition that affects how I absorb pills.

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I haven't taken certain medications in the last 14 days.

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

Side effects data

From 2021 Phase 4 trial • 45 Patients • NCT03416374

29%

Diarrhoea

24%

White blood cell count decreased

20%

Platelet count decreased

16%

Rash

16%

Neutrophil count decreased

11%

Pneumonia

Constipation

Malaise

Pyrexia

Anaemia

Nasopharyngitis

Decreased appetite

Taste disorder

Acute kidney injury

Influenza

Bile duct stone

Gastroenteritis

Pneumonia bacterial

Bone pain

Febrile neutropenia

Duodenal ulcer

Enterocolitis

Tibia fracture

Interstitial lung disease

Prinzmetal angina

Compression fracture

Spinal compression fracture

Tumour lysis syndrome

100%

80%

60%

40%

20%

Study treatment Arm

[Overall]; Combination Therapy + Ixazomib Therapy

[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy

[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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 Treatment6 Interventions

INDUCTION: Patients receive ixazomib PO, gemcitabine IV over 90 minutes, and doxorubicin IV over 15-30 minutes on day 1. Treatment repeats every 14 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive ixazomib PO and gemcitabine IV over 90 minutes. Cycles repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

FDA approved

Gemcitabine

FDA approved

Ixazomib

FDA approved

Ixazomib

FDA approved