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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Tragara Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Tragara Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01699152
First received: October 1, 2012
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Drug: TG02 citrate
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Dose-Escalation and Pharmacokinetic Study of TG02 Citrate in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Resource links provided by NLM:


Further study details as provided by Tragara Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Maximum Tolerated Dose [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Safety [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    To assess the number of patients with adverse events as a measure of safety


Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TG02 citrate
TG02 citrate capsules given orally.
Drug: TG02 citrate
TG02 citrate capsules
Other Name: No other names

Detailed Description:

The primary objective is to determine the highest dose of TG02 citrate that can be safely given to patients with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically confirmed Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma.
  • Patients must meet one or more of the following indications for treatment:

    1. Progressive disease or marked splenomegaly and/or lymphadenopathy.
    2. Anemia (hemoglobin <11 mg/dL) or thrombocytopenia (platelets<100,000/μL).
    3. Unexplained weight loss exceeding 10% of body weight over the previous 6 months.
    4. CTCAE Grade 2 or 3 fatigue.
    5. Fevers >100.5º F or night sweats for more than 2 weeks without evidence of infection.
    6. Progressive lymphocytosis, with an increase exceeding 50% over a 2 month period or a doubling time of less than 6 months.
    7. 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.
  • Life expectancy ≥ 12 weeks.
  • Patients must have normal organ and marrow function as defined below:

    • absolute neutrophil count >1,000/μL in absence of bone marrow involvement
    • platelets ≥30,000/μL in absence of bone marrow involvement
    • If patient has extensive bone marrow involvement, minimum ANC and platelet levels are not required.
    • total bilirubin ≤1.5 X institutional ULN unless due to Gilbert's syndrome, controlled autoimmune hemolytic anemia or immune thrombocytopenia
    • AST(SGOT)/ALT(SGPT) <2.5 X institutional ULN unless due to disease
    • creatinine <2.0 mg/dL OR creatinine clearance >50 mL/min/1.73 m2
  • Negative serum or urine pregnancy test at the time of first dose for WOCBP.
  • Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for required assessments.
  • Ability to take oral medication.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699152

Contacts
Contact: M Syto 760-208-6916 msyto@tragarapharma.com

Locations
United States, Georgia
GRU Completed
Augusta, Georgia, United States, 30912
United States, Massachusetts
DFCI Recruiting
Boston, Massachusetts, United States, 02215
Contact: Main Line    617-582-7292      
United States, Ohio
OSU Recruiting
Columbus, Ohio, United States, 43210
Contact: Main Line    800-293-5066      
United States, Tennessee
SCRI Recruiting
Nashville, Tennessee, United States, 37203
Contact: Main Line    615-329-7274      
United States, Texas
MDACC Recruiting
Houston, Texas, United States, 77030
Contact: Main Line    713-745-0428      
Sponsors and Collaborators
Tragara Pharmaceuticals, Inc.
Investigators
Study Director: M Syto Tragara Pharmaceuticals
  More Information

No publications provided

Responsible Party: Tragara Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01699152     History of Changes
Other Study ID Numbers: TG02-102
Study First Received: October 1, 2012
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Tragara Pharmaceuticals, Inc.:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Citric Acid
Anticoagulants
Chelating Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sequestering Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014