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LiPlaCis

Phase 1

Phase 1: Advanced or Refractory Solid Tumours | Small molecule | Oncology |Allarity Therapeutics, Inc.|Last Updated: Feb 24, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

LiPlaCis · 1 trial · 2 indications

Phase 1 1
NCT01861496Phase I/II Study to Evaluate the Safety and Tolerability of LiPlaCis in Patients With Advanced or Refractory TumoursPhase 1: Advanced or Refractory Solid Tumours
COMPLETED50 Analytics
PHASE1COMPLETED
Phase I/II Study to Evaluate the Safety and Tolerability of LiPlaCis in Patients With Advanced or Refractory Tumours
Phase 1: Advanced or Refractory Solid TumoursUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum tolerated dose (MTD) and recommended dose (RD) by evaluating the safety and tolerability
one year

Primary Objective: Assessment of adverse events and laboratory abnormalities

Secondary Endpoints

Maximum Observed Plasma Concentrations of platinum (Cmax)
Prior to the initial dose on day 1, day 8 and 15 and 5 min before end of infusion, 5 min, 0,5, 1, 3, 7, 24, 48, 72 hours post dose
Concentration of platinum (Pt-DNA)
Prior to the initial dose on day 1and 24 hours after
Area Under the Plasma - Time Concentration Curve (AUC)
Prior to the initial dose on day 1, day 8 and 15 and 5 min before end of infusion, 5 min, 0,5, 1, 3, 7, 24, 48, 72 hours post dose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LiPlaCisEXPERIMENTALDose escalation of LiPlaCis - a liposomal formulation of cisplatin will be administered intravenously in cycles every 3 weeks on day 1, day 8. Upon the investigator's judgement the patient may continue treatment for more than 3 cycles when benefiting from the study drug.

Interventions

NameTypeDescription
LiPlaCisDRUGLiPlaCis IV every 3 weeks on day 1, day 8
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Histological or cytological documented locally advanced or metastatic solid tumour relapsed on 2 or more different prior therapies. From step 5 and extension phase, population limited to Skin Cancer patients (non screened) or metastatic Breast Cancer patients or metastatic cas...

Countries:Denmark
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Frequently asked questions about LiPlaCis

What is LiPlaCis used for?

LiPlaCis is an investigational small molecule being studied for the treatment of advanced or refractory solid tumours. It is in Phase 1 clinical development for this indication, with a completed Phase I/II trial that also included Phase 2 parts for metastatic breast cancer, prostate cancer, and skin cancer.

Who makes LiPlaCis?

LiPlaCis is being developed by Allarity Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker ALLR. The company is conducting clinical research on this investigational oncology drug.

What phase is LiPlaCis in?

LiPlaCis is in Phase 1 clinical development for advanced or refractory solid tumours. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and tolerability.

What clinical trials is LiPlaCis in?

LiPlaCis has one completed clinical trial, NCT01861496, titled "Phase I/II Study to Evaluate the Safety and Tolerability of LiPlaCis in Patients With Advanced or Refractory Tumours." This trial enrolled 50 participants in Denmark and was an uncontrolled, non-randomized study.

Is LiPlaCis the same as any other drug?

LiPlaCis is the drug name used in clinical development by Allarity Therapeutics. No alternative names for this drug have been disclosed in the available clinical trial information.