NCT02220049

Dose Escalation of Velcade Daily Dose in Patients With Solid Tumors

Phase I Dose Escalation of Velcade (Bortezomib) Daily Dose in Patients With Advances or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

VELCADE has demonstrated marked activity in haematological cancers leading to registration (MM, MCL). Currently only biweekly or weekly regimens have been explored. Key signalling pathways which are aberrant in haematological cancers are also present in solid tumors. VELCADE covers a broad spectrum of proteins, which are pivotal in carcinogenesis.VELCADE as a single agent \& in combination with chemotherapy in solid cancers has shown modest and real anti-tumor activity but insufficient for Phase III development. VELCADE PK exposure may be inadequate in solid tumors compared to "liquid cancers." VELCADE daily low dose administration may allow a greater PK exposure to be achieved, which is tolerated Hypotheses: VELCADE daily dosing (5-days on, 2-days off) is tolerable at biologically active doses VELCADE daily dosing (5-days on, 2-days off) results in increased PK (AUC)/PD (20S proteasome inhibition) VELCADE daily dosing (5-days on, 2-days off) with increased PK/PD results in improved anti-tumor activity (Increased tolerable VELCADE AUC may potentially cross the threshold required for clinically significant anti-tumor activity in solid cancers). Some preclinical data suggest that: VELCADE daily dosing results in increased proteasome inhibition in tumor tissues Combination of VELCADE + XRT/other daily dosing agent may have increased anti-tumor activity compared to monotherapy alone.

Conditions

• Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	Bortezomib

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2014-08-19
• Last updated: 2016-03-25

Locations

1 site across 1 country: France