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A Phase I, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR104 Given With Prophylactic G-CSF in Subjects With Solid Tumors

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR104 Given With Prophylactic G-CSF in Subjects With Solid Tumors



- Determine the maximum tolerated dose of PR-104 in combination with filgrastim (G-CSF)
in patients with solid tumors.


- Characterize the safety of this regimen in these patients.

- Evaluate the pharmacokinetics of PR-104 and its alcohol metabolite.

- Evaluate the rate of hypoxia in various solid tumors using F-MISO PET
(18F-fluoromisonidazole positron emission tomography) imaging.

- Assess for antitumor toxicity in these patients.

- Collect plasma samples for the assessment of potential biomarkers of tumor hypoxia.

OUTLINE: This is a multicenter, dose-escalation study of PR-104.

Patients receive PR-104 IV over 1 hour on day 1 and filgrastim (G-CSF) on day 2. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients also undergo 18F-fluoromisonidazole PET scans at baseline and prior to course 3 to
assess tumor hypoxia.

Patients undergo blood sample collection periodically during course 1. Samples are analyzed
for the pharmacokinetics of PR-104 and for identification of biomarkers for tumor hypoxia.

After completion of study treatment, patients are followed at 30 days.

Inclusion Criteria


- Histologically or cytologically confirmed solid tumors

- Measurable or evaluable disease


Inclusion criteria:

- ECOG performance status 0-1

- Absolute neutrophil count ≥ 1.5 x 10^9/L

- Platelet count ≥ 100 x 10^9/L

- Hemoglobin ≥ 9 g/dL (no red blood cell transfusions allowed)

- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

- PTT ≤ 1.5 times normal

- Serum creatinine ≤ 1.5 times ULN

- ALT or AST ≤ 2 times ULN (≤ 5 times ULN if liver metastases are present)

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 30 days after
completion of study therapy

- Able to read, understand, and provide written informed consent

Exclusion criteria:

- Evidence of a significant medical disorder or laboratory finding that, in the opinion
of the investigator, compromises the patient's safety during study participation,
including any of the following:

- Uncontrolled infection or infection requiring a concomitant parenteral

- Uncontrolled diabetes

- Congestive heart failure

- Myocardial infarction within the past 6 months

- Chronic renal disease

- Coagulopathy (excluding prophylactic anticoagulation)

- Known HIV positivity

- Hepatitis B sAg-positive or known to be hepatitis C-positive with abnormal liver
function tests


- No more than 3 prior myelosuppressive chemotherapy regimens

- Patients who have received more than 3 prior myelosuppressive regimens may be
eligible, if considered to have adequate marrow, based on prior exposure to 1 of
the following regimens:

- Minimally myelosuppressive regimens

- Limited courses of myelosuppressive regimens

- More than 4 weeks since prior and no other concurrent licensed or investigational
anticancer treatment (6 weeks for nitrosoureas or mitomycin C)

- More than 24 hours since any prior radiotherapy and no likelihood of toxicity from
this therapy

- More than 4 weeks since major surgery

- No prior radiotherapy to > 20% of bone marrow

- No prior high-dose chemotherapy (including either myeloablative or non-myeloablative

- Prior and concurrent androgen deprivation therapy allowed

- Concurrent systemic steroids allowed, provided the patient has been on a stable dose
for at least 2 weeks prior to first dose of PR-104

- No concurrent irradiation therapy (palliative or therapeutic), unless given in the
absence of tumor progression

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of PR-104

Outcome Time Frame:

3 weeks (cycle 1)

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

June 2009

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



Virginia G. Piper Cancer Center at Scottsdale Healthcare - SheaScottsdale, Arizona  85260
South Texas Accelerated Research TherapeuticsSan Antonio, Texas  78229