Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Safety Study Using Pentamidine in Patients With Pancreatic Cancer Undergoing Standard Therapy

This study has been completed.
Sponsor:
Information provided by:
Oncozyme Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00810953
First received: December 16, 2008
Last updated: June 27, 2011
Last verified: June 2011

December 16, 2008
June 27, 2011
January 2009
June 2010   (final data collection date for primary outcome measure)
Any severe events, tumor marker CA19-9, and tumor size (CT scan) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00810953 on ClinicalTrials.gov Archive Site
TDP [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Safety Study Using Pentamidine in Patients With Pancreatic Cancer Undergoing Standard Therapy
A Phase I/II Clinical Study Using Pentamidine in Patients With Locally Advanced or Metastatic Pancreatic Cancer Undergoing Standard Therapy

The purpose of this study is to investigate the safety and possible efficacy of the use of pentamidine in the treatment of pancreatic cancer metastasis in subjects receiving standard therapy.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
Drug: Pentamidine
two dose of 6 mg/kg with or without standard chemotherapy.
Experimental: single arm
Use of pentamidine in locally advanced or metastatic pancreatic cancer
Intervention: Drug: Pentamidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2011
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically proven diagnosis of advanced pancreatic adenocarcinoma that is unresectable or metastatic. At least one uni-dimensionally measurable lesion (on spiral CT scan)
  • 18 years of age or older
  • ECOG performance status 0, 1 or 2
  • Serum aspartate transaminase (AST) serum alanine transaminase (ALT) £ 2.5 x upper limit of normal (ULN), or AST and ALT £ 5 x ULN if liver function abnormalities are due to underlying malignancy
  • Total serum bilirubin £ 2 x ULN
  • lipase within normal limits (1.5x ULN)
  • Absolute neutrophil count (ANC) ≥ 1500/uL (1.5 x 109/L)
  • Platelets ≥ 100,000/uL
  • Hemoglobin ≥ 9.0 g/dL
  • Serum creatinine £ 1.5 x ULN or calculated creatinine clearance ≥ 50 ml/min
  • CA19-9 level ≥ 37 U/ml
  • Normal ECG
  • Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures
  • Life expectancy, in the opinion of the investigator, > 3 months

Exclusion Criteria:

  • BP < 100 (systolic)
  • History of uncontrolled renal disease, pancreatitis, or diabetes mellitus
  • Peripheral sensory neuropathy (> Grade 1, as per NCI CTCAE version 3.0)
  • Concomitant therapy with other investigational agents or participation in another clinical trial within the previous 3 months.
  • Any of the following conditions: Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2; atrial fibrillation of any grade; QTc interval >450 msec for males or >470 msec for females or uncontrolled intercurrent illness, e.g., unstable angina; severe coronary disease, ventricular arrhythmias, bradycardia <50 bpm
  • Active uncontrolled bacterial infection
  • Concurrent use of drugs that could prolong QT interval
  • Concurrent use of nephrotoxic drugs, including aminoglycosides, ampho B, foscarnet, cidofovir
  • Concurrent use of drugs that may be associated with pancreatitis
  • Concurrent active cancer originating from a primary site other than pancreas or history of cancer < 3 years except for skin superficial bladder, uterus etc
  • History of allergy or hypersensitivity to pentamidine
  • Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to first dose of study medication.
  • Severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgement of the investigator, excess risk associated with trial participation of study drug administration, or which in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
  • On oral anticoagulants (LMWH is acceptable)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00810953
OP-103-P
Yes
Dr. Terry Chow/President, Oncozyme Pharma Inc.
Oncozyme Pharma Inc.
Not Provided
Principal Investigator: Petr Kavan, MD, Ph.D. McGill University
Oncozyme Pharma Inc.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP