A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton’s Tyrosine Kinase Inhibitor, in Patients with B-Cell Malignancies

TG-1701

A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients with B-Cell Malignancies

Disease:

chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstrom’s macrogloblinemia, mantle cell lymphoma, follicular lymphoma, diffuse large B-cell lymphoma, marginal zone lymphoma

Summary:

Non-Hodgkin lymphomas are cancers of white blood cells that can be divided into indolent (slow growing) and aggressive (fast growing), though they share common pathways that can be targeted by anti-cancer drugs.
This trial is for patients who have non-Hodgkin lymphoma or chronic lymphocytic leukaemia which has returned after treatment. Patients will receive TG-1701 (taken by mouth). It works by targeting an important part of the cancer cell called Bruton’s tyrosine kinase (Btk), which causes the cells to die.

Eligibility:

Include, but not limited to, the following:

• age >18
• A diagnosis of B-cell lymphoma or chronic lymphocytic leukaemia which has continued to grow (refractory) or returned (relapsed) after previous treatment
• No previous evidence of disease progressing on a Btk inhibitor
• No other active cancers (other than some cancers cured with minor operations like skin cancer)
• No other major health problems

Contact person:

Lewis Edwards

Email ledwards@linear.org.au

Phone 08 6382 5125

Principal Investigator:

Chan Cheah

Sponsor:

TG Therapeutics

Phase:

I

Protocol Number:

Trial Registration Number:

Clinical Trials.gov

ANZ Clinical Trial Registry