Overview

This trial is active, not recruiting.

Conditions non-hodgkin's lymphoma, chronic lymphocytic leukemia, peripheral t-cell lymphoma, hodgkin's lymphoma
Treatment tgr-1202
Phase phase 1
Target PI3K
Sponsor TG Therapeutics, Inc.
Collaborator SCRI Development Innovations, LLC
Start date January 2013
End date March 2017
Trial size 90 participants
Trial identifier NCT01767766, TGR-1202-101 (HEMREF 31)

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
TGR-1202 Daily Oral Dose
tgr-1202
TGR-1202 Daily Oral Dose

Primary Outcomes

Measure
Maximum Tolerated Dose acceptable for participants
time frame: 28 days (1 cycle of therapy)

Secondary Outcomes

Measure
Overall Response Rate
time frame: Up to 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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;

Additional Information

Official title A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by TG Therapeutics, Inc..