Status:
COMPLETED
Phase 1 Study of TG02 Citrate in Patients With Advanced Hematological Malignancies
Lead Sponsor:
Tragara Pharmaceuticals, Inc.
Conditions:
AML
ALL
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a multicenter, open-label, dose escalation Phase 1 study.
Detailed Description
This is a multicenter, open-label, dose escalation, Phase 1/1b study. For Parts 1, 2, and 3 of the study, the primary objective is to determine the highest dose of TG02 citrate that can safely be giv...
Eligibility Criteria
Inclusion
- Part 1
- Relapsed AML, ALL, CML in blast crisis, or MDS
- 65+ yrs with AML not eligible for standard frontline chemo
- Interval from prior treatment to time of study drug at least 5 half-lives for cytotoxic/ noncytotoxic agents.
- Persistent clinically significant toxicities from prior chemo ≤ Grd 1
- ECOG PS 0-2
- Lab values:
- Cr ≤ 2X ULN
- ALT and/or AST ≤2.5 X ULN
- Total bilirubin ≤1.5 X ULN unless considered due to Gilbert's syndrome
- Negative pregnancy test
- Can take oral med
- Part 2
- Relapsed multiple myeloma. At least ≥1 line of therapy and progressed after ≥1 prior therapy
- Measurable disease defined as at least one of the following:
- Serum M ≥500 mg/dL
- Urine M ≥200 mg per 24hr
- Involved FLC ≥10 mg/dL and abnormal FLC ratio in serum (\<0.26 or \>1.65)
- Measurable soft tissue plasmacytoma
- Persistent clinically significant toxicities from prior chemo ≤ Grd 1
- ECOG PS 0-2
- Lab values:
- ANC of \>1000/mm3
- Platelets ≥50,000/mm3
- Cr ≤2X the ULN
- ALT and/or AST ≤2.5X ULN
- Total bilirubin ≤1.5X ULN, unless considered due to Gilbert's syndrome
- Negative pregnancy test
- Can take oral med
- Part 3
- Measurable disease defined as at least one of the following:
- Serum M ≥500 mg/dL
- Urine M protein ≥200 mg per 24hr
- Involved FLC level ≥10 mg/dL and abnormal FLC ratio in serum (\<0.26 or \>1.65)
- Meet at least one of the criteria below:
- a. ≥2 prior therapies including proteasome inhibitor and immunomodulatory agent (IMiD)
- b. ≥1 prior therapy and one of the following abnormalities: 17p del, p53, 1q amp, 1p del, t(4;14)
- Interval from prior treatment to time of study drug at least 5 half-lives or 3 wks, which ever is shorter, for noncytotoxic agents
- Persistent clinically significant toxicities from prior chemo ≤ Grd 1 or Grd 2 neuropathy without pain
- ECOG PS 0-2
- Lab values:
- ANC of \>1000/mm3 independent of G-CSF
- Platelets ≥50,000/mm3 independent of transfusion
- MDRD calculated or measured CrCl of ≥30 mL/min
- ALT and/or AST ≤3X ULN
- Total bilirubin ≤2X ULN, unless considered due to Gilbert's syndrome
- Negative pregnancy test
- Can take oral med
- Part 4
- Measurable disease defined as at least one of the following:
- Serum M ≥500 mg/dL
- Urine M protein ≥200 mg per 24hr
- Involved FLC level ≥10 mg/dL and an abnormal FLC ratio in serum (\<0.26 or \>1.65)
- Received prior therapies including:
- a. bortezomib
- b. an IMiD
- c. carfilzomib. Demonstrated disease progression on or within 60d of completion of carfilzomib therapy
- Interval from prior treatment to time of study drug at least 5 half-lives or 3 wks, which ever is shorter, for noncytotoxic agents.
- Persistent clinically significant toxicities from prior chemo ≤ Grd 1, or Grd 2 neuropathy without pain.
- ECOG PS 0-2
- Lab values:
- ANC of \>1000/mm3 independent of G-CSF
- Platelets ≥50,000/mm3 independent of transfusion
- MDRD calculated or measured CrCl of ≥30 mL/min
- ALT and/or AST ≤3X ULN
- Total bilirubin ≤2X ULN, unless considered due to Gilbert's syndrome
- Negative pregnancy test
- Can take oral med
- Parts 1 and 2
Exclusion
- Previous allogenic hematopoietic transplant within 90 d
- Concurrent severe or uncontrolled medical disease that would compromise the safety or compromise the ability of the patient to complete the study
- Prolonged QTC interval \>450ms
- Symptomatic CNS metastases
- Known HIV or AIDS
- Actively treated for a second malignancy
- Pregnant or nursing women
- Part 3
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01204164
Start Date
August 1 2010
End Date
April 1 2016
Last Update
May 6 2016
Active Locations (9)
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1
RMCC
Denver, Colorado, United States, 80218
2
Emory
Atlanta, Georgia, United States, 30322
3
Rush
Chicago, Illinois, United States, 60612
4
IU
Indianapolis, Indiana, United States, 46202