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Advanced or Metastatic Solid TumorsPhase 1VELDAYNCT02220049

Dose Escalation of Velcade Daily Dose in Patients With Solid Tumors

A Phase 1 study testing Bortezomib in people with Advanced or Metastatic Solid Tumors, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced or Metastatic Solid Tumors
What is being tested?
Bortezomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteFrance
Study dates
Dec 2010to Nov 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent
  • Target population
  • Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
  • Ability to comply with visits/procedures required by the protocol
  • Life expectancy of at least 3 months
  • ECOG performance status score 0-1
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  • Subjects with Histologic or cytologic diagnosis of any solid tumor (nonhematologic malignancy).
  • A tumor paraffin tissue block or 20-30 unstained slides from the tumor tissue block or enough slides from an FNA to allow for biomarker and predictive marker analyses. (This biopsy need not be obtained fresh at the time of screening. Obtaining unstained slides from the original diagnostic biopsy will suffice to meet this requirement).
  • Measurable or evaluable disease
  • Prior anti-cancer treatments are permitted (i.e. chemotherapy, radiotherapy, hormonal, or immunotherapy) with the following exceptions:
  • Toxicity related to prior therapy must either have resolved, returned to baseline or been deemed irreversible but does not conflict with exclusion criteria. Peripheral pre-existent neuropathy of any grade related or not related to previous anticancer therapy is an exclusion criterion.
  • At least 3 weeks must have elapsed since the last chemo-therapy, immunotherapy or radiotherapy and the beginning of protocol therapy. At least 6 weeks for nitrosoureas, mitomycin C and liposomal doxorubicin.
  • At least 3 weeks must have elapsed since the last anti-cancer hormonal therapy or antibody targeted therapy (e.g. Bevacizumab, Cetuximab, Trastuzumab). Hormonal treatment by analog LHRH will be allowed for patients with prostate cancer For extended-release formulations, the washout period must extend 1 month beyond the duration of activity of the formulation (e.g., 3 months for the activity of a depot formulation + 1 month wash out).
  • Age and Sex
  • men and women 18 - 75
  • Male and female patients of childbearing potential must use effective contraceptive measures during the study an d for at least 3 months after the end of the study treatment

Who cannot join

  • Sex and Reproductive Status
  • Male and female patients of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to three months after the study.
  • Male and female patients of childbearing potential using a prohibited contraceptive method.
  • Women who are pregnant or breastfeeding.
  • Women with a positive pregnancy test on enrollment or prior to study drug administration.
  • Target Disease Exclusions:
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  • Subjects who have documented unstable or untreated brain metastasis for at least 4 weeks and who are still requiring steroids (Subjects with treated and stably controlled CNS metastases for at least 4 weeks and are no longer on steroids are eligible for this study).
  • Medical History and Concurrent Diseases
  • A serious uncontrolled medical disorder or active infection, which would impair the ability of the subject to receive protocol therapy
  • History of thromboembolic disease or bleeding diatheses within the last six (6) months. This includes those subjects with tumors that were known to have spontaneously bled in the past.
  • History or presence of the diffuse interstitial lung disease or pericardial disease
  • Previous history or current presence of neurological disorders, including epilepsy, Parkinson's disease, multiple sclerosis, stroke.
  • Pre-existent peripheral neuropathy of any grade, related or unrelated to previous anticancer therapy. However, asymptomatic infraclinical neuropathy with moderate measurable changes revealed by EMG will be allowed.
  • Uncontrolled or significant cardiovascular disease including
  • myocardial infarction within 12 months- uncontrolled angina within 6 months
  • congestive heart failure within 6 months
  • LVEF ≤ 45% at baseline, or <55% if prior exposure to anthracyclines
  • diagnosed or suspected congenital long QT syndrome.
  • any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or "Torsade de Pointes"). Controlled atrial fibrillation is not an exclusion criterion.
  • pericardial effusion
  • Subjects with concomitant other malignancies (except non-melanomatous skin cancers, early stage prostate or cervical cancers) are excluded unless a complete remission was achieved at least 5 years prior to study entry and no additional therapy is required or anticipated to be required during the study period
  • Subjects receiving any drugs or agents that inhibit (e.g., cimetidine, erythromycin, fluoxetine, ketoconazole, paroxetine) or induce (e.g., carbamazepine, glucocorticoids, phenobarbital, rifampin) CYP2C19 or CYP3A4 within 14 days before the first dose of VELCADE
  • Need for therapy with concomitant CYP 3A4 inhibitors (e.g., itraconazole,fluconazole,clarithromycin,erythromycin, norfloxacin, fluvoxamine, cimetidine, indinavir, ritonavir) or inducers (e.g., efavirenz, barbiturates, phenytoin, rifampin, glitazones)
  • Green tea consummation
  • Physical and Laboratory Test Findings (as confirmed by repeat test/results)
  • Inadequate bone marrow function defined as:
  • absolute neutrophil count < 1,500 cells/mm3.
  • platelet count < 100,000 cells/mm3.
  • hemoglobin < 9.0 g/dl
  • Inadequate hepatic function defined as:
  • total bilirubin > 1.5 times the institutional upper limit of normal (IULN) unless identified as a result of a confirmed genetic disorder of bilirubin metabolism (e.g., Gilbert's syndrome or familial benign unconjugated hyperbilirubinaemia).
  • alanine transaminase (ALT) and aspartate transaminase (AST) > 2.5 times the IULN
  • Inadequate renal function defined as serum creatinine >1.5 times the IULN
  • PT- INR/PTT >1.5 times the IULN is an exclusion criteria
  • If proteinuria ≥ 1+ then quantify by urinary protein in random urine sample; eligible if <1 g/l .
  • Allergies and Adverse Drug Reactions history of allergy to Velcade or chemically related compounds
  • Other Exclusion Criteria:
  • prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Gustave Roussy

    Villejuif, Val de Marne, 94805

Other trials in France

About this study

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

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.

Read more

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.

Being tested
Bortezomib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02220049
Study groupRoleWhat they receive
VelcadeExperimentalDose 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
Receives: Drug: Bortezomib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identify maximum tolerated dose

    Measured: Assessed every week from inclusion during the first 28 days and then every 28 days up to 19 months

Secondary outcomes (1)

  1. Efficacy

    According to the WHO criteria for tumor response

    Measured: Assessed within 7 days of every cycle (28 days) up to 19 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2014 (estimated)
  2. Study startDec 2010
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02220049
Sponsor's protocol ID
2009-014354-15
Other IDs
2009/1520, 2009
Acronym
VELDAY
Status last verified
Aug 2026
First submitted
18 Aug 2014
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No

Publications

  • Bahleda R, Le Deley MC, Bernard A, Chaturvedi S, Hanley M, Poterie A, Gazzah A, Varga A, Touat M, Deutsch E, Massard C, Van De Velde H, Hollebecque A, Sallansonnet-Froment M, Ricard D, Taillia H, Angevin E, Ribrag V, Soria JC. Phase I trial of bortezomib daily dose: safety, pharmacokinetic profile, biological effects and early clinical evaluation in patients with advanced solid tumors. Invest New Drugs. 2018 Aug;36(4):619-628. doi: 10.1007/s10637-017-0531-3. Epub 2017 Nov 2.

    PubMed 29094232

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bortezomib in people with Advanced or Metastatic Solid Tumors, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02220049, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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