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Trial of the Combination of Bortezomib and Clofarabine in Adults With Relapsed Solid Tumors

NCT02211755 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-04-28

No results posted yet for this study

Summary

Background:

\- Researchers want to develop better ways to treat cancer. In this study, they will give people with cancer two drugs. These drugs have been used on their own to treat some blood cell cancers.

Objectives:

\- To test the safety and efficacy of the drug combination of bortezomib and clofarabine.

Eligibility:

\- Adults age 18 and over with advanced cancer that has progressed after receiving standard treatment or that has no effective therapy.

Design:

* Participants will be screened with medical history, physical exam, and scans to measure their tumors. They will also have heart, blood, and urine tests. All of these may be done by their regular doctors.
* Participants will get the study drugs in 21-day cyles. They will stay at the clinic for week 1 of every cycle, then have 2 weeks off.

\<TAB\>- Bortezomib will be injected under the skin on days 1 and 4.

\<TAB\>- Clofarabine will be injected in a vein for days 1-5.

* During cycle 1 only, participants will go to the clinic or their doctor to have a physical exam and blood tests at the start of the second and third week.
* Participants will have clinical evaluations throughout the study, including before receiving treatment and then before the start of each cycle.
* Participants may stay in the study as long as they are tolerating the drugs and their tumor is not getting worse.
* Participants will have follow-up for 30 days after the last dose of study drugs.
* The first part of this study tests the safety of different doses of clofarabine and bortezomib.
* The second part of this study involves a separate group of participants who will undergo mandatory research biopsies to learn more about the effects of clofarabine and bortezomib on cancer cells.

Conditions

Interventions

DRUG

Bortezomib plus Clofarabine

The proteasome inhibitor bortezomib and purine nucleoside metabolic inhibitor clofarabine demonstrated greater than additive activity in combination in preclinical xenograft models

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Alice P Chen, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-06
Primary Completion
2025-08-14
Completion
2025-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02211755 on ClinicalTrials.gov