- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01358227
A Phase I Dose Escalation Trial of PR104 Given Weekly in Subjects With Solid Tumors
May 23, 2011 updated by: Proacta, Incorporated
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
The purpose of this study is to determine the side effects and best weekly dose of PR104 in patients with advanced solid tumors.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Auckland, New Zealand
- University of Auckland
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Waikato, New Zealand
- Waikato Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: PR104
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Dose escalation of PR104 to determine maximum tolerated dose for weekly administration
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the maximum tolerated dose (MTD) of PR104 when administered weekly
Time Frame: 4 weeks (cycle 1)
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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:
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4 weeks (cycle 1)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mark McKeage, PhD, FRACP, University of Auckland, New Zealand
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
May 18, 2011
First Submitted That Met QC Criteria
May 19, 2011
First Posted (Estimate)
May 23, 2011
Study Record Updates
Last Update Posted (Estimate)
May 24, 2011
Last Update Submitted That Met QC Criteria
May 23, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR104-1002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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