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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am surgically sterile.
Select...
I have been postmenopausal for at least one year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated doses (MTDs) for the combination therapy of ixazomib citrate and gemcitabine hydrochloride/doxorubicin hydrochloride, defined as dose pairs where the target dose limiting toxicity probability is 30% (phase I)
Secondary outcome measures
Objective response (phase II extension)
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
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Ixazomib Citrate
2012
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,745 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,610 Total Patients Enrolled
Arlene O Siefker-RadtkePrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't been treated with specific cancer drugs before for my condition.I haven't had a heart attack in the last 6 months and don't have severe heart issues.I am not on IV antibiotics for an infection.I don't have GI issues that affect medicine absorption or swallowing.I haven't had cancer, except for specific non-aggressive types, in the last 2 years.My platelet count is below 100 x 10^9/L without recent transfusions.I have severe nerve damage in my hands or feet, or moderate with pain.I am currently pregnant or breastfeeding.My heart pumps well despite past heart issues or specific cancer treatment.I am a male and agree to follow the birth control requirements.I can care for myself, but my cancer affects my daily activities.I do not have an active infection, hepatitis B or C, or HIV.My cancer can be measured or evaluated, with specific size requirements for different areas.My cancer is a type of bladder cancer that cannot be surgically removed.I am surgically sterile.I have symptoms of heart failure.I have recovered from previous chemotherapy with minimal side effects.I have had at least one treatment before, or I cannot or will not take cisplatin-based therapy.I have unstable chest pain.I haven't taken specific strong medications or herbal supplements in the last 14 days.My brain metastases are stable and I have no worsening symptoms.I have significant artery blockage.I have had a stroke or mini-stroke in the past year.You are allergic to any of the study medications or the ingredients used to make them.I agree to practice true abstinence as a form of contraception.I don't have any serious health or mental conditions that could stop me from completing the treatment.I experience leg pain when walking that limits my activities.My kidney function, measured by creatinine clearance, is below 30 mL/min.I haven't had radiotherapy in the last 28 days, or if it was a small area, in the last 14 days.I have not had major surgery in the last 14 days.I have had any number of previous treatments for my condition.I am a patient.I have been postmenopausal for at least one year.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ixazomib, gemcitabine, doxorubicin)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any previous examinations involving Ixazomib Citrate?
"Currently, there are 846 ongoing clinical trials dedicated to Ixazomib Citrate. Phase 3 of these studies is being carried out in 251 locations, with the majority situated in Melbourne, Victoria. Across the globe however, 48913 medical centres have recruited patients for this treatment."
Answered by AI
Is this a pioneering clinical trial?
"Currently, 846 trials are ongoing for Ixazomib Citrate spanning 84 nations and 2919 cities. The inaugural study was hosted by Alfacell in 1997, involving 300 people and culminating with Phase 3 drug approval. Since then, 1570 studies have concluded their data collection stages."
Answered by AI
Is there any availability for participants in this experiment?
"This clinical trial, which was initially launched in July of 2015 and last updated on the 18th of July 2022, is no longer actively recruiting participants. However, 3364 additional studies are currently searching for volunteers to join their trials."
Answered by AI
How many participants are necessary for the success of this research endeavor?
"As of the last edit on 7/18/2022, this clinical trial is not actively recruiting. If you seek further trials to partake in, there are 2518 active studies looking for patients with unresectable transitional cell carcinoma and 846 pursuing participants for Ixazomib Citrate research."
Answered by AI
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