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

This study is currently recruiting participants.

Verified April 2013 by TG Therapeutics, Inc.

Sponsor:

Collaborator:

Sarah Cannon Research Institute

Information provided by (Responsible Party):

TG Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT01767766

First received: January 9, 2013

Last updated: April 13, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 9, 2013

Last Updated Date

April 13, 2013

Start Date ^ICMJE

January 2013

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum Tolerated Dose acceptable for participants [ Time Frame: 28 days (1 cycle of therapy) ] [ Designated as safety issue: Yes ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01767766 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall Response Rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

To assess the overall response rate (ORR) in patients with hematologic malignancies treated with TGR-1202

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: TGR-1202

TGR-1202 Daily Oral Dose

Study Arm (s)

Experimental: TGR-1202

TGR-1202 Daily Oral Dose

Intervention: Drug: TGR-1202

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2014

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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;
Primary central nervous system lymphoma or known intracranial involvement.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: TG Therapeutics Clinical Support Team

212-554-4484

clinicalsupport@tgtxinc.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01767766

Other Study ID Numbers ^ICMJE

TGR-1202-101 (HEMREF 31)

Has Data Monitoring Committee

Yes

Responsible Party

TG Therapeutics, Inc.

Study Sponsor ^ICMJE

TG Therapeutics, Inc.

Collaborators ^ICMJE

Sarah Cannon Research Institute

Investigators ^ICMJE

Study Chair:

Michael R. Savona, MD, FACP

Sarah Cannon Research Institute

Information Provided By

TG Therapeutics, Inc.

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top