Ixazomib, Gemcitabine, and Doxorubicin in Treating Patients With Locally Advanced or Metastatic Kidney Cancer

NCT03587662 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-09

No results posted yet for this study

Summary

This phase II trial studies how well ixazomib, gemcitabine, and doxorubicin work in treating patients with kidney cancer that has spread to other places in the body (locally advanced or metastatic). Ixazomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as 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. Giving ixazomib, gemcitabine, and doxorubicin may work better in treating patients with kidney cancer.

Conditions

  • Metastatic Kidney Medullary Carcinoma
  • Metastatic Renal Cell Carcinoma
  • SMARCB1 Negative
  • Stage III Renal Cell Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8

Interventions

DRUG

Doxorubicin

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Gemcitabine

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

DRUG

Ixazomib

Given PO

DRUG

Ixazomib Citrate

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Pavlos Msaouel · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-17
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03587662 on ClinicalTrials.gov