NCT01767766

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_1

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2013

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

5.1 years

First QC Date

January 9, 2013

Last Update Submit

August 20, 2021

Conditions

Non-Hodgkin's LymphomaChronic Lymphocytic LeukemiaPeripheral T-Cell LymphomaHodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose acceptable for participants

    To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.

    28 days (1 cycle of therapy)

Secondary Outcomes (1)

  • Overall Response Rate

    Up to 1 year

Study Arms (1)

TGR-1202

EXPERIMENTAL

TGR-1202 Daily Oral Dose

Drug: TGR-1202

Interventions

TGR-1202DRUG

TGR-1202 Daily Oral Dose

TGR-1202

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

TG Therapeutics Trial Site

Sarasota, Florida, 34232, United States

Location

TG Therapeutics Trial Site

Hackensack, New Jersey, 07601, United States

Location

TG Therapeutics Trial Site

New York, New York, 10019, United States

Location

TG Therapeutics Trial Site

Durham, North Carolina, 27710, United States

Location

TG Therapeutics Trial Site

Cincinnati, Ohio, 45242, United States

Location

TG Therapeutics Trial Site

Nashville, Tennessee, 37203, United States

Location

TG Therapeutics Investigational Trial Site

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • Burris HA 3rd, 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. Umbralisib, a novel PI3Kdelta and casein kinase-1epsilon inhibitor, in relapsed or refractory chronic lymphocytic leukaemia and lymphoma: an open-label, phase 1, dose-escalation, first-in-human study. Lancet Oncol. 2018 Apr;19(4):486-496. doi: 10.1016/S1470-2045(18)30082-2. Epub 2018 Feb 20.

    PMID: 29475723DERIVED

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-CellLymphoma, T-Cell, PeripheralHodgkin Disease

Interventions

umbralisib

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, T-Cell

Study Officials

  • Howard Burris, MD, FACP

    SCRI Development Innovations, LLC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2013

First Posted

January 14, 2013

Study Start

January 7, 2013

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

August 23, 2021

Record last verified: 2021-08

Locations

US(7)