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A Phase I Multicenter, Open-label Study of the Effect on QTc, Pharmacokinetics, Safety, and Preliminary Efficacy of Single-agent Palifosfamide-tris in Subjects With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Advanced Solid Tumors

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Trial Information

A Phase I Multicenter, Open-label Study of the Effect on QTc, Pharmacokinetics, Safety, and Preliminary Efficacy of Single-agent Palifosfamide-tris in Subjects With Advanced Solid Tumors

Inclusion Criteria

Inclusion criteria:

1. Male or female subjects, age ≥ 18 years, who have provided written informed
consent prior to completing any study specific procedure.

2. Histologically or cytologically confirmed solid tumor that has progressed following
available standard therapies or for which no standard therapy exist.

3. Measurable or non-measurable disease by RECIST version 1.1

4. Must have recovered from toxic effects of prior cancer treatment to ≤ Grade1per CTCAE
v4.0, with the exception of any alopecia.

5. ECOG Performance Status of 0 or 1.

6. Adequate bone marrow, liver, and renal function, as assessed by the following
laboratory requirements:

1. Hemoglobin ≥9.0 g/dL.

2. Absolute neutrophil count (ANC) ≥1,500/uL.

3. Platelet count ≥100,000/uL.

4. Total bilirubin ≤1.5 x upper limit of normal (ULN)

5. ALT and AST ≤2.5 x ULN. For subjects with documented liver metastases, ALT and

6. International Normalized Ratio (INR) and activated partial thromboplastin time
[PTT] <1.5 x ULN, if not therapeutically anticoagulated. Subjects who are being
therapeutically anticoagulated with an agent such as Coumadin (warfarin sodium)
or subcutaneous heparin may be included provided there is no prior evidence of
underlying abnormality in coagulation parameters, screening test results are in
appropriate therapeutic range, and anticoagulation regimen is stable and closely

7. Estimated glomerular filtration rate (eGRF) ≥60 mL/minute/1.73 m2.

7. Male and female subjects must agree to use a highly reliable method of birth control
(expected failure rate less than 5% per year) from the screening visit through 28
days after the last dose of study drug.

Exclusion Criteria:

1. Subjects who have received prior chemotherapy, radiation therapy or any
investigational agent within 28 days prior to the first dose of study drug.

2. Unstable or clinically significant concurrent medical condition that would, in the
opinion of the investigator, jeopardize the safety of a subject and/or their
compliance with the protocol. Examples include, but are not limited to, unstable
angina, congestive heart failure, recent (within 2 months of screening) myocardial
infarction, ongoing maintenance therapy for life-threatening ventricular arrhythmia,
uncontrolled asthma, HIV/AIDS without adequate anti-viral therapy, evidence of
hepatic pathology due to or consistent with infection with a chronic hepatitis virus,
uncontrolled major seizure disorder, or electrolyte imbalances.

3. Presence of, or history of any illness or injury to the urinary tract (renal or
post-renal) which may make the subject more susceptible to acute renal insufficiency
in the case of potential renal adverse events. Types of injury or illness might
include a history of polycystic renal disease, nephrectomy, renal transplant, acute
or chronic renal failure.

4. Active infection requiring systemic antibacterial, antifungal, or antiviral therapy
within 2 weeks of the first dose of study drug. Subjects with HIV who are on
effective anti-viral therapy or subjects with chronic herpes infections who use
intermittent suppressive antiviral therapy for viral outbreaks may be included.

5. Major surgery within 4 weeks prior to start of treatment.

6. Documented symptomatic brain metastases. Screening for brain lesions by CT or MRI is
not required for potential subjects; however, if there are any neurological signs or
symptoms consistent with brain metastases, then a brain CT or MRI should be performed
as clinically indicated.

7. Currently pregnant or nursing.

8. Subjects with implantable pacemaker or automatic implantable cardioverter

9. Conditions that make the screening ECG repolarization difficult to interpret, or
showing significant abnormalities. This includes, but is not limited to: high degree
AV block, pace-maker, atrial fibrillation or flutter, prolonged QTc >500ms on repeat
measurements (e.g., 2 out of 3 ECGs), or bradycardia (defined as ≤ 50 beats/minute).

10. Subjects who will be receiving medications that prolong the QT interval with a risk
of causing Torsades de Pointes during the time period beginning 1 week prior to and
during the Intensive ECG monitoring period (i.e., Cycle 1, Day -8 through Day 8).

Type of Study:


Study Design:

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

Outcome Measure:

ECG QTc intervals of patients who receive palifosfamide-tris

Outcome Description:

To assess the effect of single-agent palifosfamide-tris on QTc intervals.

Outcome Time Frame:

Cycle 1 Days -1,1, 2, 3,8

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

August 2012

Related Keywords:

  • Advanced Solid Tumors
  • Phase I
  • Safety
  • PK
  • ECG QTc
  • Efficacy
  • Palifosfamide-tris
  • non-randomized
  • Neoplasms



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