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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
PR104-1002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unspecified Adult Solid Tumor, Protocol Specific 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Determine the maximum tolerated dose (MTD) of PR104 when administered weekly - 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)
Timepoint [1] 0 0
4 weeks (cycle 1)

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Waikato

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Proacta, Incorporated
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01358227
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark McKeage, PhD, FRACP
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications