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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01358227
Registration number
NCT01358227
Ethics application status
Date submitted
18/05/2011
Date registered
23/05/2011
Date last updated
24/05/2011
Titles & IDs
Public title
A Phase I Dose Escalation Trial of PR104 Given Weekly in Subjects With Solid Tumors
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Scientific 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
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Secondary ID [1]
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PR104-1002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Unspecified Adult Solid Tumor, Protocol Specific
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PR104
Experimental: PR104 -
Treatment: Drugs: PR104
Dose escalation of PR104 to determine maximum tolerated dose for weekly administration
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Determine the maximum tolerated dose (MTD) of PR104 when administered weekly
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Assessment method [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:
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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Timepoint [1]
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4 weeks (cycle 1)
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2010
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Sample size
Target
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Accrual to date
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Final
26
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Waikato
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Proacta, Incorporated
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01358227
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mark McKeage, PhD, FRACP
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Address
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University of Auckland, New Zealand
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01358227
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