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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/NCT00459836




Registration number
NCT00459836
Ethics application status
Date submitted
11/04/2007
Date registered
13/04/2007
Date last updated
2/03/2011

Titles & IDs
Public title
PR-104 and Docetaxel or Gemcitabine in Treating Patients With Solid Tumors
Scientific title
A Phase Ib, Multi-Center, Open-Label, Dose Escalation Trial of Intravenous PR-104 Given in Combination With Docetaxel or Gemcitabine in Subjects With Solid Tumors
Secondary ID [1] 0 0
PROACTA-PR-104-1003
Secondary ID [2] 0 0
PR104-1003
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 - PR-104
Treatment: Drugs - docetaxel
Treatment: Drugs - gemcitabine hydrochloride
Other interventions - laboratory biomarker analysis
Other interventions - pharmacological study

Treatment: Drugs: PR-104


Treatment: Drugs: docetaxel


Treatment: Drugs: gemcitabine hydrochloride


Other interventions: laboratory biomarker analysis


Other interventions: pharmacological study
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum tolerated dose of PR-104
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Safety of PR-104 as measured by CTCAE v3.0 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 the blood
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Pharmacokinetics of gemcitabine and docetaxel in the presence of PR-104
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Antitumor activity
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed solid tumor malignancy

- Treatment with either docetaxel or gemcitabine hydrochloride in combination with an
investigational agent is reasonable

- Measurable or evaluable disease

PATIENT CHARACTERISTICS:

- ECOG performance status of 0-1

- Absolute neutrophil count = 1,500/mm³

- Platelet count = 100,000/mm³

- Hemoglobin = 9.0 g/dL (red blood cell transfusion allowed)

- Bilirubin normal

- ALT and AST = 2.5 times upper limit of normal (ULN)

- Creatinine = 1.5 times ULN

- PT/INR or aPTT = 1.1 times ULN

- Not pregnant or nursing

- Negative pregnancy test

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

- No evidence of any other significant medical disorder, including uncontrolled
infection or infection requiring a concurrent parenteral antibiotic, or laboratory
finding that, in the opinion of the investigator, would preclude study compliance

- No known HIV positivity

- No hepatitis B surface antigen positivity

- No hepatitis C positivity with abnormal liver function test

PRIOR CONCURRENT THERAPY:

- No prior radiotherapy to > 25% of bone marrow

- No prior high-dose chemotherapy (including conditioning for either myeloablative or
nonmyeloablative transplantation)

- No more than 3 prior chemotherapy regimens

- More than 4 weeks since prior major surgery

- More than 4 weeks since prior investigational or traditional anticancer therapy
(including radiotherapy) (6 weeks for nitrosoureas and mitomycin C)

- The following medications/treatments are not permitted during the trial:

- Any other licensed or investigational anticancer treatment

- Prophylactic hematopoietic growth factors

- Irradiation therapy (palliative or therapeutic) unless given in the absence of
tumor progression

- Concurrent systemic steroids allowed provided the patient is on a stable dose for = 2
weeks prior to study treatment

- Concurrent androgen-deprivation therapy allowed
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
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, docetaxel, and gemcitabine, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Giving more than one drug (combination chemotherapy) 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 docetaxel or gemcitabine in treating patients with solid tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00459836
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Terri J. Melink, NP, MSN, ANP
Address 0 0
Proacta, Incorporated
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