Trial of Ixazomib Combined With Gemcitabine and Doxorubicin in Patients With Renal Medullary Carcinoma
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|ClinicalTrials.gov Identifier: NCT03587662|
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : August 27, 2018
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.
The goal of this clinical research study is to learn if the combination of ixazomib, gemcitabine, and doxorubicin can help to control renal medullary carcinoma (RMC).
This is an investigational study. Ixazomib is FDA approved and commercially available for the treatment of multiple myeloma. Gemcitabine and doxorubicin are FDA approved and commercially available for several other types of cancer such as urothelial or bladder cancer. It is considered investigational to use ixazomib, gemcitabine, and doxorubicin to treat RMC.
The study doctor can explain how the study drugs are designed to work.
Up to 30 participants will be enrolled in this study. All will take part at MD Anderson
|Condition or disease||Intervention/treatment||Phase|
|Kidney Medullary Carcinoma Stage III Renal Cell Cancer AJCC v8 Stage IV Renal Cell Cancer AJCC v8||Drug: Doxorubicin Drug: Gemcitabine Drug: Ixazomib||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Ixazomib Combined With Gemcitabine and Doxorubicin in Patients With Renal Medullary Carcinoma|
|Actual Study Start Date :||August 17, 2018|
|Estimated Primary Completion Date :||January 6, 2021|
|Estimated Study Completion Date :||January 6, 2021|
Experimental: Treatment (ixazomib, gemcitabine, doxorubicin)
INDUCTION: Participants 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 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Participants receive ixazomib PO and gemcitabine IV over 90 minutes. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
- Objective response (complete response or partial response) assessed by Response Evaluation Criteria in Solid (RECIST) 1.1 [ Time Frame: Up to 2 years ]
- Disease control (stable disease or better) measured by RECIST 1.1 [ Time Frame: At week 28 ]
- Incidence of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: Up to 2 years ]
- Overall survival [ Time Frame: From treatment start date until death from any cause (event) or last contact date for patients last known to be alive (censor), assessed up to 2 years ]
- Progression-free survival [ Time Frame: From treatment start date until progression (event) or death from any cause (event), assessed up to 2 years ]
- Duration of response [ Time Frame: From first documented response until progression (event) or death from any cause (event), assessed up to 2 years ]
- Biomarker analysis of biomarkers PDI, BiP, eIF2aP assessed in tumor tissue samples [ Time Frame: Up to 2 years ]
- IL-6 measured serum samples [ Time Frame: Up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587662
|Contact: Pavlos Msaouelfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: M. email@example.com|
|Principal Investigator:||Pavlos Msaouel||M.D. Anderson Cancer Center|