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VLI

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment67
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00364676Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's DiseasePHASE1 COMPLETED 67Jul 1, 2006Aug 1, 2015Sep 22, 20153 United States, Canada
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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 — 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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Competitive Landscape -Brain Tumors 139 trials
CompanyTickerTrialsLead PhaseDrugs
NovoCure Ltd.NVCR5PHASE3Temozolomide, Pembrolizumab, Poly-ICLC, Peptides, Concurrent Optune and RT followed by Optune System alone
Jazz Pharmaceuticals Public Limited CompanyJAZZ4PHASE3Dordaviprone, Everolimus, ONC201, JZP3507, ONC206
Day One Biopharmaceuticals, Inc.DAWN2PHASE3Tovorafenib, Chemotherapeutic Agent
Nuvation Bio, Inc. Class ANUVB1PHASE3safusidenib
Tango Therapeutics, Inc.TNGX3PHASE3Vorasidenib, Temozolomide, TNG456, abemaciclib
Telix Pharmaceuticals Limited Sponsored ADRTLX2PHASE3TLX-101-Tx + Lomustine, 131I-IPA
Eli Lilly and CompanyLLY3PHASE2Abemaciclib, Temozolomide, LY3410738, Gemcitabine, Cisplatin
Pfizer Inc.PFE3PHASE2Palbociclib, Temozolomide, Irinotecan, Topotecan, Cyclophosphamide
Novartis AG Sponsored ADRNVS3PHASE2Dabrafenib, Trametinib, Lu-NeoB, Ga-NeoB, Lu-DOTA-TATE
NeOnc Technologies Holdings, Inc.NTHI4PHASE2NEO100, NEO212, Ipilimumab, Pembrolizumab, Nivolumab
Exelixis, Inc.EXEL2PHASE2Zanzalintinib, Cabozantinib
CNS Pharmaceuticals, Inc.CNSP1PHASE2Berubicin, Lomustine
Black Diamond Therapeutics, Inc.BDTX1PHASE2silevertinib in combination with temozolomide, temozolomide
Actuate Therapeutics, Inc.ACTU1PHASE29-ING-41, Gemcitabine - 21 day cycle, Doxorubicin., Lomustine, Carboplatin.
Rigel Pharmaceuticals, Inc.RIGL1PHASE2Olutasidenib + TMZ
Apollomics Inc. Class AAPLM1PHASE2APL-101
ImmunityBio IncIBRX1PHASE2Bevacizumab, PD-L1 t-haNK, N-803
Cooper Companies, Inc.COO1PHASE2Pre-radiation temozolomide.
Incyte CorporationINCY1PHASE2Ruxolitinib, Temozolomide
AstraZeneca PLCAZN2PHASE1AZD1390, Olaparib, Durvalumab, Physicians Choice systemic chemotherapy
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