← Back to Search

Proteasome Inhibitor; Purine Analog

Bortezomib + Clofarabine for Cancer

Phase 1

Recruiting

Led By Naoko Takebe, M.D.

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

Age greater than or equal to 18 years

ECOG performance status less than or equal to 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, cycle 1 day 1, and cycle 2 day 4/day 5

Awards & highlights

Study Summary

This trial is testing the safety and efficacy of the drug combination of bortezomib and clofarabine to treat cancer.

Who is the study for?

Adults over 18 with advanced cancer that's worsened after standard treatment or lacks effective therapy can join. They need normal organ/marrow function, a life expectancy over 3 months, and must use contraception. Excluded are pregnant/breastfeeding women, those with certain heart conditions, uncontrolled illnesses, severe neuropathy, active brain metastases/CNS disease, or allergies to similar drugs.Check my eligibility

What is being tested?

The trial tests the safety and effectiveness of combining Bortezomib and Clofarabine in treating solid tumors and lymphoma. Participants receive these drugs in cycles: Bortezomib by injection on days 1 & 4; Clofarabine intravenously on days 1-5. The study includes initial dose-safety testing followed by an expansion cohort for further evaluation.See study design

What are the potential side effects?

Potential side effects include reactions at the injection site for Bortezomib and infusion-related reactions from Clofarabine. Both drugs may cause blood disorders (like low platelet counts), liver issues (elevated bilirubin levels), fatigue, digestive problems (nausea/vomiting), increased risk of infection due to lowered white blood cell counts.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

My cancer has not responded to standard treatments or there are no treatments available.

Select...

I finished my last cancer treatment at least 3 weeks ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, cycle 1 day 1, and cycle 2 day 4/day 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, cycle 1 day 1, and cycle 2 day 4/day 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, cycle 1 day 1, and cycle 2 day 4/day 5 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Safety and MTD

Secondary outcome measures

Biomarkers of DNA damage and apoptosis in circulating tumor cells

Biomarkers of cell death and DNA damage in tumor biopsy tissue

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment1 Intervention

Starting doses are clofarabine at 1 mg/m2 IV on days 1 through 5 of a 21-day cycle, and bortezomib at 0.8 mg/m2 subcutaneously on days 1 and 4 of a 21-day cycle.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,703 Previous Clinical Trials

40,931,675 Total Patients Enrolled

Naoko Takebe, M.D.Principal InvestigatorNational Cancer Institute (NCI)

3 Previous Clinical Trials

157 Total Patients Enrolled

Media Library

Bortezomib plus Clofarabine (Proteasome Inhibitor; Purine Analog) Clinical Trial Eligibility Overview. Trial Name: NCT02211755 — Phase 1

Myelodysplastic Syndrome Research Study Groups: 1

Myelodysplastic Syndrome Clinical Trial 2023: Bortezomib plus Clofarabine Highlights & Side Effects. Trial Name: NCT02211755 — Phase 1

Bortezomib plus Clofarabine (Proteasome Inhibitor; Purine Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02211755 — Phase 1

Frequently Asked Questions

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

How many participants have agreed to be part of this research effort?

"Indeed, the details posted on clinicaltrials.gov suggest that this experiment is currently enrolling volunteers. It was initialy launched on October 6th 2014 and had its latest update published on November 9th 2022. A total of 75 people are needed to take part at 2 medical centres."

Answered by AI

What potential harm can be caused by the combination of Bortezomib and Clofarabine?

"Due to the limited clinical data supporting both safety and efficacy, Bortezomib plus Clofarabine is currently estimated at a score of 1."

Answered by AI

Is enrollment currently open for this experiment?

"Affirmative. Clinicaltrials.gov attests that this trial, which was inaugurated on October 6th 2014, is actively recruiting participants. 75 individuals need to be enrolled from 2 distinct healthcare facilities."

Answered by AI