Spots Global Cancer Trial Database for Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
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Trial Identification
Brief Title: Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
Official Title: A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
Study ID: NCT03671590
Study Description
Brief Summary: This is a Phase 1 trial to evaluate the safety, pharmacokinetics and efficacy of TG-1701, a Bruton's Tyrosine Kinase (BTK) inhibitor in patients with relapsed or refractory B-cell malignancies.
Detailed Description: This Phase I clinical trial aims to evaluate the safety of the investigational drug TG-1701 both as a single-agent and in combination with other investigational drugs, specifically ublituximab and umbralisib. As per protocol v6.0, combination therapy (TG-1701 + Ublituximab + Umbralisib) will be discontinued and the participants from Arm 1 and 2 will be transitioned to the long-term extension period to receive TG-1701 monotherapy.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
TG Therapeutics Investigational Trial Site, East Melbourne, Victoria, Australia
TG Therapeutics Investigational Trial Site, Fitzroy, Victoria, Australia
TG Therapeutics Investigational Trial Site, Nedlands, Western Australia, Australia
TG Therapeutics Investigational Trial Site, Adelaide, , Australia
TG Therapeutics Investigational Trial Site, Kraków, , Poland
TG Therapeutics Investigational Trial Site, Lublin, , Poland
TG Therapeutics Investigational Trial Site, Warszawa, , Poland
TG Therapeutics Investigational Trial Site, Wrocław, , Poland
Contact Details
Name: Constantine S. Tam, MD
Affiliation: St. Vincents Hospital
Role: STUDY_CHAIR
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