Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies

Conditions

Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Peripheral T-Cell Lymphoma, Hodgkin's Lymphoma

Brief summary

The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients with advanced hematologic malignancies.

Burris HA, Flinn IW, Patel MR, Fenske TS, Deng C, Brander DM, Gutierrez M, Essell JH, Kuhn JG, Miskin HP, Sportelli P, Weiss MS, Vakkalanka S, Savona MR, O'Connor OA.

2018-02-20145 citations

10.1016/s1470-2045(18)30082-2

Long-term follow-up of the PI3Kδ inhibitor TGR-1202 to demonstrate a differentiated safety profile and high response rates in CLL and NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab.

Howard A. Burris, Ian W. Flinn, Matthew A. Lunning, Julie M. Vose, Nathan Fowler et al. (20 authors)

Journal of Clinical Oncology2016-05-2020 citations

10.1200/jco.2016.34.15_suppl.7512

Activity of TGR-1202, a novel once-daily PI3Kδ inhibitor, in patients with relapsed or refractory hematologic malignancies.

Howard A. Burris, Manish R. Patel, Mark C. Lanasa, Danielle M. Brander, Owen A. O’Connor et al. (13 authors)

Journal of Clinical Oncology2014-05-2015 citations

10.1200/jco.2014.32.15_suppl.2513

Interventions

DRUGTGR-1202

TGR-1202 Daily Oral Dose

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Refractory to or relapsed after at least 1 prior treatment regimen; * Eastern Cooperative Oncology Group (ECOG) score of 0 to 2; * At least 18 years of age.

Exclusion criteria

* Any major surgery, chemotherapy or immunotherapy within the last 21 days (limited palliative radiation is allowed ≥ 2 weeks); * Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months; * Known hepatitis B virus, hepatitis C virus or HIV infection; * Previous therapy with GS-1101 (CAL-101), IPI-145 or any drug that specifically inhibits the PI3K or mTOR pathway;

Design outcomes

Primary

Measure	Time frame	Description
Maximum Tolerated Dose acceptable for participants	28 days (1 cycle of therapy)	To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.

Secondary

Measure	Time frame	Description
Overall Response Rate	Up to 1 year	To assess the overall response rate (ORR) in patients with hematologic malignancies treated with TGR-1202

Countries

United States

Outcome results

None listed