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Topotecan Liposomes

Phase 1

Small Cell Lung Cancer | Small molecule | Oncology |Assertio Holdings, Inc.|Last Updated: Nov 13, 2020

Target and mechanism

ModalitySmall molecule

Also known as Topotecan Liposomes Injection (TLI)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

Topotecan Liposomes · 1 trial · 3 indications

Phase 1 1
NCT00765973Topotecan Liposomes Injection for Small Cell Lung Cancer (SCLC), Ovarian Cancer and Other Advanced Solid TumorsSmall Cell Lung Cancer
COMPLETED14 Analytics
PHASE1COMPLETED
Topotecan Liposomes Injection for Small Cell Lung Cancer (SCLC), Ovarian Cancer and Other Advanced Solid Tumors
Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate the safety, tolerability and maximum tolerated dose of 2 different dosing schedules of TLI administered intravenously
21 days following initial dose

Secondary Endpoints

Assess the pharmacokinetic profile of TLI
21 Day Cycle
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTALArm A: TLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2)
BEXPERIMENTALArm B: TLI dose on Day 1 of a 21-day treatment cycle (Starting dose: 2 mg/m2)

Interventions

NameTypeDescription
Topotecan Liposomes Injection (TLI)DRUGTLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Age ≥ 18 years 2. Histologically or cytologically confirmed advanced solid tumor that has relapsed, is refractory to standard treatment, or for whom there is no standard therapy available. 3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 4. Normal organ ...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 387 trials (matched to "Small Cell Lung Cancer")