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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/NCT00616213




Registration number
NCT00616213
Ethics application status
Date submitted
14/02/2008
Date registered
15/02/2008
Date last updated
1/06/2011

Titles & IDs
Public title
PR104 and G-CSF in Treating Patients With Solid Tumors
Scientific title
A Phase I, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR104 Given With Prophylactic G-CSF in Subjects With Solid Tumors
Secondary ID [1] 0 0
PROACTA-PR-104-1004
Secondary ID [2] 0 0
PR104-1004
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
Other interventions - filgrastim
Treatment: Drugs - PR104
Other interventions - F-18-fluoromisonidazole

Other interventions: filgrastim
filgrastim will be administered at a standard dose and schedule

Treatment: Drugs: PR104
PR104 is administered intravenously once every 21 days

Other interventions: F-18-fluoromisonidazole
F-18-fluoromisonidazole is administered intravenously prior to performance of PET scan
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum tolerated dose of PR-104
Timepoint [1] 0 0
3 weeks (cycle 1)
Secondary outcome [1] 0 0
Safety profile using CTCAE v3 criteria
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Dose-limiting toxicity of PR-104
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Pharmacokinetics of PR-104 and its alcohol metabolite in blood
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Anti-tumor activity
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Biomarkers of tumor hypoxia
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed solid tumors

- Measurable or evaluable disease

PATIENT CHARACTERISTICS:

Inclusion criteria:

- ECOG performance status 0-1

- Absolute neutrophil count = 1.5 x 10^9/L

- Platelet count = 100 x 10^9/L

- Hemoglobin = 9 g/dL (no red blood cell transfusions allowed)

- Serum bilirubin = 1.5 times upper limit of normal (ULN)

- PTT = 1.5 times normal

- Serum creatinine = 1.5 times ULN

- ALT or AST = 2 times ULN (= 5 times ULN if liver metastases are present)

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 30 days after
completion of study therapy

- Able to read, understand, and provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Evidence of a significant medical disorder or laboratory finding that, in the opinion
of the investigator, compromises the patient's safety during study participation,
including any of the following:

- Uncontrolled infection or infection requiring a concomitant parenteral antibiotic

- Uncontrolled diabetes

- Congestive heart failure

- Myocardial infarction within the past 6 months

- Chronic renal disease

- Coagulopathy (excluding prophylactic anticoagulation)

- Known HIV positivity

- Hepatitis B sAg-positive or known to be hepatitis C-positive with abnormal liver
function tests

PRIOR CONCURRENT THERAPY:

- No more than 3 prior myelosuppressive chemotherapy regimens

- Patients who have received more than 3 prior myelosuppressive regimens may be
eligible, if considered to have adequate marrow, based on prior exposure to 1 of
the following regimens:

- Minimally myelosuppressive regimens

- Limited courses of myelosuppressive regimens

- More than 4 weeks since prior and no other concurrent licensed or investigational
anticancer treatment (6 weeks for nitrosoureas or mitomycin C)

- More than 24 hours since any prior radiotherapy and no likelihood of toxicity from
this therapy

- More than 4 weeks since major surgery

- No prior radiotherapy to > 20% of bone marrow

- No prior high-dose chemotherapy (including either myeloablative or non-myeloablative
transplantations)

- Prior and concurrent androgen deprivation therapy allowed

- Concurrent systemic steroids allowed, provided the patient has been on a stable dose
for at least 2 weeks prior to first dose of PR-104

- No concurrent irradiation therapy (palliative or therapeutic), unless given in the
absence of tumor progression

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
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2009
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton

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

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in
bone marrow or peripheral blood and may help the immune system recover from the side effects
of chemotherapy. Giving PR-104 together with G-CSF may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given
together with G-CSF in treating patients with solid tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00616213
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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