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VLI

Phase 1

Tumors | Small molecule | Oncology |Assertio Holdings, Inc.|Last Updated: Sep 22, 2015

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment67

FDA Designations

No designations recorded

Clinical trial landscape

VLI · 1 trial · 3 indications

Phase 1 1
NCT00364676Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's DiseaseTumors
COMPLETED67 Analytics
PHASE1COMPLETED
Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease
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Study Endpoints

Primary Endpoints

Evaluate the safety and tolerability of VLI.
21 Days

Secondary Endpoints

To determine the maximum tolerated dose (MTD)
21 Days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALPatients are dosed on Day 1 and Day 8 of a 21-day cycle.
2EXPERIMENTALPatients are dosed on Day 1 of a 21-day cycle.

Interventions

NameTypeDescription
VLIDRUGPatients are dosed on Day 1 and Day 8 of a 21-day cycle.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Histologically confirmed solid tumor refractory to standard therapy or for which no standard therapy is known to exist, or relapsed and/or refractory non-Hodgkin's lymphoma or Hodgkin's disease 2. Adequate hematologic, hepatic and renal functions as defined by laboratory test...

Countries:United StatesCanada
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Frequently asked questions about VLI

What is VLI used for?

VLI is an investigational small molecule being developed for the treatment of tumors, including solid tumors, Hodgkin's disease, and non-Hodgkin's lymphoma. It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes VLI?

VLI is being developed by Assertio Holdings, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ASRT. The drug is currently in Phase 1 clinical development for oncology indications.

What phase is VLI in?

VLI is in Phase 1 clinical development. One Phase 1 trial has been completed, and the drug remains investigational. It has not received FDA approval and is not yet available as a marketed therapy.

What clinical trials is VLI in?

VLI has been studied in one completed Phase 1 clinical trial, NCT00364676, which evaluated the drug in patients with advanced solid tumors, non-Hodgkin's lymphoma, or Hodgkin's disease. The trial enrolled 67 participants in the United States and Canada.

Is VLI the same as vinorelbine liposomes injection?

Yes, VLI refers to vinorelbine liposomes injection. The completed Phase 1 trial, NCT00364676, was titled 'Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease' and enrolled 67 patients.