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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-07

Study Completion Date

2018-02-28

Brief Summary

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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TGR-1202

TGR-1202 Daily Oral Dose

Group Type EXPERIMENTAL

TGR-1202

Intervention Type DRUG

TGR-1202 Daily Oral Dose

Interventions

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TGR-1202

TGR-1202 Daily Oral Dose

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No