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NCT03395210 : An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenia

Male or<br/>FemaleGender Male or

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18-80Age 18-80

Blood<br/>CancersCancer LocationBlood

Systemic therapy | Blood / Myeloma / LymphomaEssential Thrombocytosis

Trial Overview Read MoreRead more

This phase I/II trial is trying to understand the safety and effectiveness of a targeted therapy (PRN1008) in people with relapsed Immune Thrombocytopenia.

This trial is treating patients with Immune Thrombocytopenia.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT03395210
  • 2019.282 PRINCIPIA BIOPHARMA - PRN1008-010 - CT1191

Scientific Title

An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenia

Commercial Sponsor

Principia Biopharma, a Sanofi Company


This is a 2 part, adaptive, open-label dose-finding study of PRN1008 in people with Immune Thrombocytopenic Purpura (ITP). Part A enrols people with ITP who are refractory or relapsed with no available and approved therapeutic options. Eligible patients have a platelet count <30,000 l="" on="" two="" counts="" no="" sooner="" than="" 7="" days="" apart="" in="" the="" 15="" days="" before="" treatment="" begins.="" the="" active="" treatment="" period="" is="" 24="" weeks="" and="" the="" post-treatment="" follow-up="" period="" is="" 4="" weeks.="" in="" the="" dose-finding="" part="" of="" the="" study,="" each="" patient="" enrolled="" in="" the="" study="" is="" allowed="" to="" up-titrate="" their="" dose="" after="" 28="" days="" of="" prn1008="" therapy,="" if="" they="" do="" not="" experience="" a="" platelet="" response="" or="" a="" dose-limiting="" toxicity="" (dlt)="" at="" the="" last="" dose="" level.="" patients="" who="" respond="" to="" prn1008="" per="" protocol="" may="" enter="" a="" long="" term-extension.="" part="" b="" of="" the="" study="" will="" include="" people="" with="" itp="" who="" have="" relapsed="" or="" have="" insufficient="" response="" to="" prior="" therapies.="" eligible="" patients="" will="" have="" a="" platelet="" count=""><30,000 l="" on="" two="" occasions="" no="" less="" than="" 7="" days="" apart,="" within="" 15="" days="" before="" treatment="" begins="" and="" a="" platelet="" count="" of="" ≤35,000/µl="" on="" study="" day="" 1="" (sd1).="" the="" study="" consists="" of="" a="" 28-day="" screening="" period,="" 24-week="" active="" treatment="" period,="" and="" a="" long-term="" extension.="" after="" the="" last="" dose="" of="" prn1008="" there="" will="" be="" a="" 4-week="" safety="" follow-up="">

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Jessica Ahern

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.