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A Phase 1 Dose-Escalation and Pharmacokinetic Study of TG02 Citrate in Patients With Advanced Hematological Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
AML, ALL, Blast Crisis, MDS, Multiple Myeloma

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Trial Information

A Phase 1 Dose-Escalation and Pharmacokinetic Study of TG02 Citrate in Patients With Advanced Hematological Malignancies


This is a multicenter, open-label, dose escalation study. The primary objective is to
determine the highest dose of TG02 citrate that can safely be given to patients with
different types of hematological malignancy.

Inclusion Criteria


Inclusion Criteria (Leukemia Patients):

1. Patients with the following histologically confirmed relapsed hematological
malignancies for whom no curative treatment or standard therapy that conveys clinical
benefit is available:

- Acute myelogenous leukemia (AML)

- Acute lymphocytic leukemia (ALL)

- Chronic myelogenous leukemia (CML) currently in blast crisis (defined as ≥30%
blasts in bone marrow)

- High-risk myelodysplasia (MDS)

2. Elderly patients (65 y/o or older) with AML who are not eligible for standard
frontline chemotherapy or who refuse treatment with intensive therapy.

3. The interval from prior treatment to time of study drug administration should be at
least 5 half-lives for cytotoxic and noncytotoxic agents.

4. Persistent clinically significant toxicities from prior chemotherapy must be ≤Grade
1.

5. Eastern Clinical Oncology Group Performance Status (ECOG PS) of 0, 1, or 2.

6. Laboratory values within the following ranges:

- Creatinine ≤2 X the upper limit of normal (ULN)

- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤2.5 X
the ULN

- Total bilirubin ≤1.5 X the ULN, unless considered due to Gilbert's syndrome

7. Negative serum or urine pregnancy test at the time of first dose for women of
childbearing potential (WOCBP). For men and WOCBP, adequate contraception must be
used throughout the study.

8. Ability to take oral medication.

Inclusion Criteria (Multiple Myeloma Patients):

1. Patients with relapsed multiple myeloma. Patients must have received at least one
line of therapy, must have progressed after at least one prior therapy, and be
patients for whom no standard therapy is available, or who decline such options.
Prior autologous and/or allogeneic transplant is permitted.

2. Patients must have measurable disease (within 14 days prior to enrollment) defined as
at least one of the following:

- Serum monoclonal protein (M protein) ≥500 mg/dL

- Urine monoclonal protein ≥200 mg per 24 hours

- Involved free light chain level ≥10 mg/dL (≥100 mg/L) and an abnormal free light
chain ratio in serum (<0.26 or >1.65)

- Measurable soft tissue (not bone) plasmacytoma (should be measured within 28
days of first dose of study drug)

3. Persistent clinically significant toxicities from prior chemotherapy must be ≤Grade
1.

4. Eastern Clinical Oncology Group Performance Status (ECOG PS) of 0, 1, or 2.

5. Laboratory values within the following ranges:

- Absolute neutrophil count of >1000/mm3

- Platelet count of ≥50,000/mm3

- Creatinine ≤2 X the ULN

- ALT and/or AST ≤2.5 X the ULN

- Total bilirubin ≤1.5 X the ULN, unless considered due to Gilbert's syndrome

6. Negative serum or urine pregnancy test at the time of first dose for women of
childbearing potential (WOCBP). For men and WOCBP, adequate contraception must be
used throughout the study.

7. Ability to take oral medication.

Exclusion Criteria (Entire Patient Population):

1. Previous allogenic hematopoietic transplant within 90 days of study enrollment.

2. Concurrent severe or uncontrolled medical disease (i.e., active systemic infection,
diabetes, HTN, CAD, CHF) 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.

3. Patients with prolonged QTC interval of >450ms as calculated by Fridericia correction
formula.

4. Symptomatic central nervous system (CNS) metastases. Patients with asymptomatic CNS
disease may receive standard intrathecal chemotherapy prior to enrollment and
continue once dosed with study drug.

5. Known HIV or AIDS.

6. Patients being actively treated for a second malignancy.

7. Pregnant or nursing women.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Tolerated Dose

Outcome Description:

To assess number of patients with dose-limiting toxicities

Outcome Time Frame:

28 days

Safety Issue:

No

Principal Investigator

Tracy Parrott

Investigator Role:

Study Director

Investigator Affiliation:

Tragara Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

TG02-101

NCT ID:

NCT01204164

Start Date:

August 2010

Completion Date:

October 2013

Related Keywords:

  • AML
  • ALL
  • Blast Crisis
  • MDS
  • Multiple Myeloma
  • AML
  • ALL
  • MDS
  • CML in blast crisis
  • Multiple Myeloma
  • Blast Crisis
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms

Name

Location

RMCCDenver, Colorado  80218
MDACCHouston, Texas  77030
CornellNew York, New York  
EmoryAtlanta, Georgia  
HUMCHackensack, New Jersey  07601
OSUColumbus, Ohio  43210