← Back to Search

Proteasome Inhibitor

Bortezomib + Sorafenib + Decitabine for Acute Myeloid Leukemia

Q: To what kinds of conditions are Pharmacological Studies regularly employed?

Refractory anemias, hemangiosarcomas, and progressive radioactive iodine-resistant differentiated <a href="https://www.withpower.com/clinical-trials/thyroid">thyroid</a> carcinomas can be targeted through pharmacological intervention.

Q: What is the current enrollment count for this clinical experiment?

This clinical trial has ceased recruitment of new participants. Originally posted on July 3rd 2013, the study had its last update on June 29th 2022. For those looking for alternative studies, there are currently 1536 active trials seeking patients with acute myeloid <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> and 296 Pharmacological Studies that are open to enrolment.

Q: Is space still available for participants in this research?

According to the data hosted on clinicaltrials.gov, this experiment is no longer enrolling patients, having been last updated on June 29th 2022. However, there are still over 1800 other medical trials actively looking for individuals to participate in their research.

Q: Does the FDA approve of this particular medication trial?

The safety of Pharmacological Study was judged to be a 1 on our scale due to the fact that it is just beginning its Phase 1 trial, and therefore has limited research backing up its efficacy or security.

Q: Are there any precedent studies that have utilized Pharmacological Study?

Currently, there are 296 active trials studying Pharmacological Study with 71 in Phase 3. Taipei, Taiwan is one of the hubs for these experiments but there are 11728 other locations running similar studies.

Phase 1

Waitlist Available

Led By Alison R Walker

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must have histologically or cytologically confirmed acute myeloid leukemia (AML) by World Health Organization (WHO) criteria in the blood and/or marrow AND age >= 60 and not candidates/refuse standard induction treatment OR who have one of the following: poor risk cytogenetics, AML following antecedent hematologic disorder, or therapy-related AML

Patients with relapsed or refractory AML age >= 18 years are also eligible for treatment; patients may have been treated for antecedent hematologic disorder with myeloid growth factors, recombinant erythropoietin, thalidomide, lenalidomide, 5-azacitidine or the 5 day schedule of decitabine; patients who have received the 10 day schedule of decitabine for treatment an antecedent hematologic disorder or AML are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to up to day 12 of course 1

Awards & highlights

Study Summary

This trial is testing bortezomib and sorafenib tosylate given with decitabine to see what effects (good and bad) it has on patients with acute myeloid leukemia, and to find the best dose of the drugs to use.

Who is the study for?

This trial is for adults with acute myeloid leukemia (AML) who are either aged 60+ and can't have standard treatment, or those with high-risk AML types. It's also open to adults 18+ with relapsed/refractory AML. Participants need a performance status of <=2, acceptable liver/kidney function, no severe heart disease or active central nervous system involvement, and must agree to use contraception.Check my eligibility

What is being tested?

The trial tests the combination of bortezomib and sorafenib tosylate with decitabine in treating AML. Bortezomib/sorafenib may halt cancer cell growth by blocking enzymes they need, while decitabine could kill or stop cancer cells from dividing/spreading. The study aims to find the best dose and assess side effects.See study design

What are the potential side effects?

Potential side effects include reactions related to enzyme inhibition that might affect cell growth elsewhere in the body, typical chemotherapy-related issues like nausea, fatigue, blood disorders; organ inflammation; possible infection risks due to immune system impact; and nerve damage.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 60 or older with AML and cannot or choose not to undergo standard treatment, or I have high-risk AML.

Select...

I am 18 or older with AML that has come back or didn't respond to treatment, and I haven't been treated with a 10-day decitabine schedule.

Select...

My kidney function is normal, with creatinine levels below 2.0 mg/dL or clearance above 60 mL/min.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I agree to use effective birth control or remain abstinent during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to up to day 12 of course 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to up to day 12 of course 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to up to day 12 of course 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

BETD of bortezomib, sorafenib tosylate, and decitabine using National Cancer Institute Common Terminology Criteria for Adverse Events version 4

Secondary outcome measures

CR rate

Change in miR-29b expression in blood and bone marrow

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (bortezomib, sorafenib tosylate, decitabine)Experimental Treatment5 Interventions

STEP A: Patients receive bortezomib SC on days 1 and 4, sorafenib tosylate PO BID on days 1-14, and decitabine IV over 1 hour on days 5-14. STEP B: Patients receive bortezomib SC on days 1, 4, and 8 or 1, 4, 8 and 11, sorafenib tosylate PO BID on days 1-14, and decitabine IV over 1 hour on days 9-18 or 12-21. STEP C: Patients receive bortezomib SC on days 1, 4, and 8 or 1, 4, 8 and 11, sorafenib tosylate PO BID on days 1-14, and decitabine IV over 1 hour on days 5-14. Treatment repeats every 28 days for up to 4 courses in the absence of unacceptable toxicity. Patients achieving CR or CRi receive maintenance therapy comprising decitabine IV on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bortezomib

2005

Completed Phase 2

~1140

Decitabine

2004

Completed Phase 3

~1680

Sorafenib Tosylate

2005

Completed Phase 3

~4010

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,652 Total Patients Enrolled

Alison R WalkerPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01861314 — Phase 1

Acute Myeloid Leukemia Research Study Groups: Treatment (bortezomib, sorafenib tosylate, decitabine)

Acute Myeloid Leukemia Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT01861314 — Phase 1

Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01861314 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what kinds of conditions are Pharmacological Studies regularly employed?

"Refractory anemias, hemangiosarcomas, and progressive radioactive iodine-resistant differentiated thyroid carcinomas can be targeted through pharmacological intervention."

Answered by AI

What is the current enrollment count for this clinical experiment?

"This clinical trial has ceased recruitment of new participants. Originally posted on July 3rd 2013, the study had its last update on June 29th 2022. For those looking for alternative studies, there are currently 1536 active trials seeking patients with acute myeloid leukemia and 296 Pharmacological Studies that are open to enrolment."

Answered by AI

Is space still available for participants in this research?

"According to the data hosted on clinicaltrials.gov, this experiment is no longer enrolling patients, having been last updated on June 29th 2022. However, there are still over 1800 other medical trials actively looking for individuals to participate in their research."

Answered by AI

Does the FDA approve of this particular medication trial?

"The safety of Pharmacological Study was judged to be a 1 on our scale due to the fact that it is just beginning its Phase 1 trial, and therefore has limited research backing up its efficacy or security."

Answered by AI

Are there any precedent studies that have utilized Pharmacological Study?

"Currently, there are 296 active trials studying Pharmacological Study with 71 in Phase 3. Taipei, Taiwan is one of the hubs for these experiments but there are 11728 other locations running similar studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bortezomib, Sorafenib Tosylate, and Decitabine in Treating Patients With Acute Myeloid Leukemia

2013. "Bortezomib, Sorafenib Tosylate, and Decitabine in Treating Patients With Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01861314.

All > Acute Myeloid Leukemia > Nexavar