Dose Escalation of Velcade Daily Dose in Patients With Solid Tumors (VELDAY)
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|ClinicalTrials.gov Identifier: NCT02220049|
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : March 25, 2016
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
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced or Metastatic Solid Tumors||Drug: Bortezomib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Dose Escalation of Velcade (Bortezomib) Daily Dose in Patients With Advances or Metastatic Solid Tumors|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Dose level Dose(mg/m²) d1-5, d8-12, d15-19 Cohort -2 Velcade 0.3 mg/m² Cohort -1 Velcade 0.4 mg/m² Cohort 1 Velcade 0.5 mg/m² Cohort 2 Velcade 0.6 mg/m² Cohort 3 Velcade 0.7 mg/m² Cohort 4 Velcade 0.8 mg/m² Cohort 5 Velcade 0.9 mg/m² Cohort 6 Velcade 1.0 mg/m² Cohort 7 Velcade 1.1 mg/m²
Other Name: VELCADE
- Identify maximum tolerated dose [ Time Frame: Assessed every week from inclusion during the first 28 days and then every 28 days up to 19 months ]
- Efficacy [ Time Frame: Assessed within 7 days of every cycle (28 days) up to 19 months ]According to the WHO criteria for tumor response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220049
|Villejuif, Val de Marne, France, 94805|
|Principal Investigator:||Rastislav BAHLEDA, MD||Gustave Roussy, Cancer Campus, Grand Paris|