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VELCADE

Phase 2

Non-Small Cell Lung Cancer | Small molecule | Oncology |Takeda Pharmaceutical Company Limited|Last Updated: Jun 25, 2012

Success Probability

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Trial Design

RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

VELCADE · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00343720Study of Alimta® (Pemetrexed) Plus VELCADE® (Bortezomib) or Alimta Alone or VELCADE Alone in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Prior TherapyNon-Small Cell Lung Cancer
COMPLETED- Analytics
PHASE2COMPLETED
Study of Alimta® (Pemetrexed) Plus VELCADE® (Bortezomib) or Alimta Alone or VELCADE Alone in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Prior Therapy
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Tolerated Dose
5 weeks in once weekly (QW) dose cohorts and 3 weeks in twice weekly (BIW) dose cohorts

Maximum Tolerated Dose (MTD) was defined as the highest dose level that has 0/1 out of 6 patients experiences Dose Limited Toxicity (DLT). MTD is defined separately for QW and BIQ dose cohorts. DLT was defined as adverse events occurring during Cycle 1 and: (1) related to VELCADE, (2) Grade 4 thrombocytopenia or neutropenia, (3) Grade 3 or higher nonhematologic toxicity.

Subjects With Treatment Emergent Adverse Events
from first study-related procedure to 30 days after last dose of study medication

Treatment emergent adverse events observed during outcome measure time frame

Subjects With Serious Treatment Emergent Adverse Events
from first study-related procedure to 30 days after last dose of study medication

Serious treatment emergent adverse events observed during outcome measure time frame

Subjects Grade 3/4/5 Treatment Emergent Adverse Events
from first study-related procedure to 30 days after last dose of study medication

Grade 3/4/5 treatment emergent adverse events observed during outcome measure time frame. Grade is determined according to Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0.

Subjects With Treatment Emergent Adverse Events Leading to Treatment Termination
from first study-related procedure to 30 days after last dose of study medication

Treatment emergent adverse events observed during outcome measure time frame leading to treatment termination

Secondary Endpoints

Best Confirmed Hematologic Responders
from first dose of study medication to end of study visit
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALVELCADE

Interventions

NameTypeDescription
VELCADEDRUG -
AlimtaDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Men or women, 18 years of age or older * Non-small cell lung cancer (NSCLC) has been histologically or cytologically confirmed * Has relapsed or refractory locally advanced (Stage IIIb) or metastatic (Stage IV) NSCLC * Failed one prior line of systemic antineoplastic therapy f...

Countries:BelgiumUnited States
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about VELCADE

What is VELCADE used for?

VELCADE is a small molecule being studied for use in Non-Small Cell Lung Cancer, Mantle Cell Lymphoma, and Amyloidosis. It is an investigational drug in clinical development for these conditions. VELCADE is developed by Takeda Pharmaceutical Company Limited.

What does VELCADE target?

VELCADE is a small molecule therapeutic. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being evaluated in clinical studies for Non-Small Cell Lung Cancer, Mantle Cell Lymphoma, and Amyloidosis.

Who makes VELCADE?

VELCADE is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials of VELCADE for Non-Small Cell Lung Cancer, Mantle Cell Lymphoma, and Amyloidosis.

What phase is VELCADE in?

VELCADE is in Phase 1 clinical development. It has completed one Phase 1 trial, one Phase 2 trial, and one Phase 3 trial. VELCADE is not approved and remains investigational for the studied indications.

What clinical trials is VELCADE in?

VELCADE has been studied in clinical trials including NCT00298766, an open-label Phase 1/2 study in patients with light-chain (AL)-amyloidosis, and NCT00722137, a Phase 3 study in patients with newly diagnosed Mantle Cell Lymphoma. These trials are completed.

Is VELCADE the same as bortezomib?

VELCADE is also known as bortezomib. Clinical trials refer to the drug as VELCADE for injection and VELCADE (bortezomib). It is being studied for Non-Small Cell Lung Cancer, Mantle Cell Lymphoma, and Amyloidosis.