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A Phase I, Multi-center, Open-label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR104 Given Weekly 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 Weekly in Subjects With Solid Tumors

Inclusion Criteria:

- Age 18 years or more

- Histologically confirmed malignancy for which no effective therapy exists

- Measurable or evaluable disease

- ECOG Performance Status of 0 or 1. See Section 15.1 (ECOG performance status) for
definition of ECOG Performance Status 0 and 1

- Ability to read, understand and provide written informed consent

- If the subject is on systemic steroids, the dose of steroids must be stable for at
least two weeks prior to the first dose of PR-104

Exclusion Criteria:

- Licensed or investigational anti-cancer therapy (including radiotherapy) within four
weeks of the baseline disease assessment (within six weeks for nitrosoureas and
Mitomycin C). Subjects on androgen deprivation therapy are allowed on study and may
continue to receive androgen deprivation therapy while one study

- Prior radiotherapy to more than 25% of bone marrow; prior high-dose chemotherapy
(including either myeloablative or non-myeloablative transplants); or prior receipt
of more than three chemotherapy regimens

- Absolute neutrophil count of < 1.5 x 109/L

- Platelet count of < 100 x 109/L

- Hemoglobin level of < 90 g/L (or requiring a red blood cell transfusion to maintain
hemoglobin > 90 g/L)

- Serum bilirubin greater than the upper limit of normal

- ALT and AST greater than 2.5 times the upper limit of normal

- Serum creatinine less than 1.5 times upper limit of normal

- Prothrombin time (PT-INR) or activated partial thromboplastin time (APTT) greater
than 1.1 times the upper limit of normal range

- Women who are pregnant, breast-feeding or planning to become pregnant during the

- Men or women of reproductive-potential who are unwilling to use an effective method
of contraception during the study and for 30 days following the last dose of study
medication. See section 5.11 (Contraceptives) for definition of effective methods of

- Evidence of any other significant medical disorder or laboratory finding that in the
opinion of the Investigator compromises the subject's safety during study
participation, including uncontrolled infection or infection requiring a concomitant
parenteral antibiotic

- Plans for concomitant anti-cancer therapy (excluding androgen deprivation therapy)
while on study

- Less than four weeks since major surgery

- Known to be HIV positive, Hepatitis B sAg positive or Hepatitis C positive with
abnormal liver function tests

- No known contraindication to single doses of naproxen

Type of Study:


Study Design:

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

Outcome Measure:

Determine the maximum tolerated dose (MTD) of PR104 when administered weekly

Outcome Description:

MTD is based on cycle 1 data and defined as the maximum dose that can be administered to 6 subjects with no more than one of the following DLTs: Grade 4 thrombocytopenia Grade 4 heme toxicity (excluding thrombocytopenia) that lasts for ≥ 5 days (Neutrophils < 500/mm3, ANC ≤ 0.5 K/mm3, lymphocytes < 1K/mm3, HGB < 6.5 gm/dL) Non-heme toxicity ≥ Grade 3 despite appropriate treatment Neutropenic fever Grade 2 or higher neurotoxicity of ≥ 1 week Any toxicity of Grade 2 or higher that has not resolved within 2 weeks of end of cycle 1 (except grade 2 alopecia)

Outcome Time Frame:

4 weeks (cycle 1)

Safety Issue:


Principal Investigator

Mark McKeage, PhD, FRACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Auckland, New Zealand


United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

January 2010

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms