NCT01699152
Completed
Phase 1
Phase 1 Dose-Escalation and Pharmacokinetic Study of TG02 Citrate in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Tragara Pharmaceuticals, Inc.5 sites in 1 country16 target enrollmentStarted: September 2012Last updated:
InterventionsTG02 citrate
DrugsTG02 citrate
Overview
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 16
- Locations
- 5
- Primary Endpoint
- Maximum Tolerated Dose
Overview
Brief Summary
This is a multi-center, open-label, dose escalation study.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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.
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.
Arms & Interventions
TG02 citrate
Experimental
TG02 citrate capsules given orally.
Intervention: TG02 citrate (Drug)
Outcomes
Primary Outcomes
Maximum Tolerated Dose
Time Frame: 28 days
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 Outcomes
- Adverse Events(28 days)
Investigators
Study Sites (5)
Loading locations...
Similar Trials
Completed
Phase 1
Phase 1 Study of TG02 Citrate in Patients With Advanced Hematological MalignanciesAMLALLBlast CrisisMDSMultiple MyelomaNCT01204164Tragara Pharmaceuticals, Inc.120
Unknown
Phase 1
Dose Escalation and Expansion Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma and LymphomaMultiple MyelomaLymphomaNCT04818372Keymed Biosciences Co.Ltd87
Withdrawn
Phase 1
Study of PF-07224826, as a Single Agent or in Combination With Endocrine Therapy in Participants With Breast Cancer and Other Advanced Solid Tumors.Breast CancerOvarian CancerLiposarcomaNon-small Cell Lung Cancer (NSCLC)EndometrialSolid TumorsNCT05905341Pfizer
Completed
Phase 1
Phase 1 Study of TG01 and Erlotinib in Non-small Cell Lung Cancer (NCSLC) PatientsNon-small Cell Lung CancerNCT00569114Tragara Pharmaceuticals, Inc.45
Completed
Phase 1
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy, Phase 1 Study of CMG901NCT04805307Keymed Biosciences Co.Ltd176