NCT02211755

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

Completed Phase 1 Last updated 28 November 2025

What this trial tests

Phase 1 trial testing Bortezomib plus Clofarabine in Neoplasms in 28 participants. Completed in 15 August 2025.

Timeline

6 October 2014

Primary endpoint
14 August 2025

15 August 2025

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	6 October 2014
Primary completion	14 August 2025
Estimated completion	15 August 2025
Sites	1 location across United States

Drugs / interventions tested

• Bortezomib plus Clofarabine — full drug profile →

Conditions studied

• Neoplasms — all drugs for Neoplasms →
• Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →
• Lymphomas — all drugs for Lymphomas →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 120, any sex, with Neoplasms or Myelodysplastic Syndromes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The National Cancer Institute ALMANAC: A Comprehensive Screening Resource for the Detection of Anticancer Drug Pairs with Enhanced Therapeutic Activity.
   Holbeck SL, Camalier R, Crowell JA, Govindharajulu JP, et al · · 2017 · cited 262× · PMID 28446463 · DOI 10.1158/0008-5472.can-17-0489
2. Trial Watch: Immunogenic cell death inducers for anticancer chemotherapy.
   Pol J, Vacchelli E, Aranda F, Castoldi F, et al · · 2015 · cited 238× · PMID 26137404 · DOI 10.1080/2162402x.2015.1008866
3. Predicting Synergism of Cancer Drug Combinations Using NCI-ALMANAC Data.
   Sidorov P, Naulaerts S, Ariey-Bonnet J, Pasquier E, et al · · 2019 · cited 114× · PMID 31380352 · DOI 10.3389/fchem.2019.00509
4. The proteasome as a druggable target with multiple therapeutic potentialities: Cutting and non-cutting edges.
   Tundo GR, Sbardella D, Santoro AM, Coletta A, et al · · 2020 · cited 78× · PMID 32442437 · DOI 10.1016/j.pharmthera.2020.107579
5. Targeted Tumor Therapy Remixed-An Update on the Use of Small-Molecule Drugs in Combination Therapies.
   Gatzka MV. · · 2018 · cited 38× · PMID 29794999 · DOI 10.3390/cancers10060155
6. Reversal gene expression assessment for drug repurposing, a case study of glioblastoma.
   Sun S, Shyr Z, McDaniel K, Fang Y, et al · · 2025 · cited 5× · PMID 39773231 · DOI 10.1186/s12967-024-06046-1
7. Unbiased High-Throughput Drug Combination Pilot Screening Identifies Synergistic Drug Combinations Effective against Patient-Derived and Drug-Resistant Melanoma Cell Lines.
   Close DA, Kirkwood JM, Fecek RJ, Storkus WJ, et al · · 2021 · cited 5× · PMID 33208016 · DOI 10.1177/2472555220970917
8. Redefining cancer care: harnessing circulating tumor cells' potential for improved diagnosis and prognosis.
   Janjua D, Chaudhary A, Joshi U, Tripathi T, et al · · 2025 · cited 4× · PMID 40676582 · DOI 10.1186/s12935-025-03883-y