Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18 - 80
Clinical summary
Summary
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/μL 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/μL 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 period.
Conditions
This trial is treating people with Immune Thrombocytopenia
Eligibility
Inclusion
- Male or female patients, aged 18 to 80 years old
- Immune-related ITP (both primary and secondary)
Exclusion
- Pregnant or lactating women
- Current drug or alcohol abuse
- History of solid organ transplant
- Positive screening for HIV, hepatitis B, or hepatitis C
Inclusion
- 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 (relapsed or recurrent).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
- NCT03395210 *
- 2019.282 PRINCIPIA BIOPHARMA - PRN1008-010 - CT1191
Trial sponsor
Principia Biopharma, a Sanofi Company
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
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