A Phase I Dose Escalation Trial of PR104 Given Weekly in Subjects With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01358227
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : May 24, 2011
Information provided by:
Proacta, Incorporated

Brief Summary:
The purpose of this study is to determine the side effects and best weekly dose of PR104 in patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: PR104 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2010

Arm Intervention/treatment
Experimental: PR104 Drug: PR104
Dose escalation of PR104 to determine maximum tolerated dose for weekly administration

Primary Outcome Measures :
  1. Determine the maximum tolerated dose (MTD) of PR104 when administered weekly [ Time Frame: 4 weeks (cycle 1) ]

    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)

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 study
  • 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 contraception
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01358227

New Zealand
University of Auckland
Auckland, New Zealand
Waikato Hospital
Waikato, New Zealand
Sponsors and Collaborators
Proacta, Incorporated
Principal Investigator: Mark McKeage, PhD, FRACP University of Auckland, New Zealand

Responsible Party: Director of Clinical Development, Proacta, Inc. Identifier: NCT01358227     History of Changes
Other Study ID Numbers: PR104-1002
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: May 24, 2011
Last Verified: May 2011