Phase 1 Study of TG02 Citrate in Patients With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

NCT01699152 | Completed Phase 1

• 1 other identifier: TG02-102
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 5

Brief Summary

This is a multi-center, open-label, dose escalation study.

Conditions

Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Keywords

Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  To assess the number of patients with dose-limiting toxicities (DLT) and the dose of TG02 citrate that can be safely given to patients with CLL or SLL.

  28 days

Secondary Outcomes (1)

• Adverse Events

  28 days

Study Arms (1)

TG02 citrate

EXPERIMENTAL

TG02 citrate capsules given orally.

Drug: TG02 citrate

Interventions

TG02 citrate DRUG

TG02 citrate capsules

Also known as: No other names

TG02 citrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma.
• Patients must meet one or more of the following indications for treatment:
• Progressive disease or marked splenomegaly and/or lymphadenopathy.
• Anemia (hemoglobin \<11 mg/dL) or thrombocytopenia (platelets\<100,000/μL).
• Unexplained weight loss exceeding 10% of body weight over the previous 6 months.
• CTCAE Grade 2 or 3 fatigue.
• Fevers \>100.5º F or night sweats for more than 2 weeks without evidence of infection.
• Progressive lymphocytosis, with an increase exceeding 50% over a 2 month period or a doubling time of less than 6 months.
• Need for cytoreduction prior to allogeneic stem cell transplant.
• Patients must have relapsed or refractory disease after ≥1 prior line of treatment.
• The interval from prior treatment to time of study drug administration should be at least 5 half-lives for cytotoxic and noncytotoxic agents.
• Low-dose corticosteroids (prednisone \<20 mg/ day or equivalent dose) are permitted throughout study.
• Clinically significant toxicities from prior chemotherapy must be resolved to Grade ≤ 1.
• Age \>18 years.
• ECOG performance status ≤2.

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (CTCAE Grade \> 1) due to agents administered more than 3 weeks earlier.
• Patients who have received prior treatment with a CDK inhibitor within 12 months of study enrollment.
• High-dose corticosteroids (prednisone ≥20mg/day or equivalent dose) must be discontinued ≥ 7 days of initiating therapy.
• Patients with known central nervous system involvement.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition as TG02 citrate.
• Patients with G6PD deficiency.
• Concurrent severe or uncontrolled medical disease (including but not limited to history of ventricular arrhythmia or symptomatic conduction abnormality within 12 months, ongoing or active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
• Pregnant and/or breast-feeding women.
• Prior or second malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or breast cancer, or other cancer for which the subject has received curative therapy at least 3 years prior to study entry.
• Known HIV or AIDs.
• QTc interval prolongation \>450ms for males and \>470 ms for females.

Sponsors & Collaborators

• Tragara Pharmaceuticals, Inc.: lead

Study Sites (5)

GRU

Augusta, Georgia, 30912, United States

Location

DFCI

Boston, Massachusetts, 02215, United States

Location

OSU

Columbus, Ohio, 43210, United States

Location

SCRI

Nashville, Tennessee, 37203, United States

Location

MDACC

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• T Parrott

  Tragara Pharmaceuticals

  STUDY DIRECTOR

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: October 1, 2012
• First Posted: October 3, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: May 1, 2016
• Last Updated: July 25, 2019

Record last verified: 2016-05

Locations

US (5)