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:

Inclusion Criteria:
1. Relapsed or refractory histologically confirmed B-cell lymphoma or CLL
2. Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
3. Adequate organ function

Exclusion Criteria:
1. Prior therapy with a BTK inhibitor (ibrutinib, acalabrutinib, other)
2. Any major surgery, chemotherapy or immunotherapy within the last 21 days
4. hepatitis B virus, hepatitis C virus or HIV infection

Contact person:

Lewis Edwards
Email ledwards@linear.org.au
Phone 08 6382 5125


Email
Phone

Principal Investigator:

Chan Cheah

Sponsor:

TG Therapeutics

Phase:

I

Protocol Number:

Trial Registration Number:

Clinical Trials.gov

ANZ Clinical Trial Registry