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A Study of CP-4126 in Patients With Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00913198
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : February 10, 2012
Sponsor:
Information provided by (Responsible Party):
Clavis Pharma

Study Description
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Brief Summary:
The main objective of this study is to assess the biological activity of CP-4126 in patients with advanced pancreatic cancer. In addition, the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be studied.

Condition or disease Intervention/treatment Phase
Advanced Adenocarcinoma of Pancreas Drug: IV CP-4126 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of CP-4126 in Patients With Advanced Pancreatic Cancer.
Study Start Date : April 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : September 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: IV CP-4126 Drug: IV CP-4126
1250 mg/m2/d, IV (in the vein) on day 1, 8 and 15 of each 4 week cycle. Number of Cycles: until progression or unacceptable toxicity develops.


Outcome Measures
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Primary Outcome Measures :
  1. Biological activity of CP-4126 in patients with advanced pancreatic cancer. [ Time Frame: Every second cycle ]

Secondary Outcome Measures :
  1. Overall survival, Objective response rate. [ Time Frame: Every second cycle - study length ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological confirmed advanced pancreatic cancer*
  • Not eligible for curative resection
  • Performance Status (ECOG) 0-2
  • Estimated life expectancy of at least 12 weeks
  • Age ≥ 18 years

  • Adequate haematological and biological functions:

    • Neutrophils ≥ 1.5 x 109/L
    • Platelets > 100.0 x 109/L
    • Hb ≥ 10 g/dL
    • AST/ALT and alkaline phosphatase (ALP) ≤ 2.5 x institutional upper limit of normal (ULN), if liver metastases
    • AST/ALT ≤ 5 x institutional ULN and ALP ≤ 4 x institutional ULN
    • Bilirubin ≤ 1.5 times institutional ULN, if liver metastases ≤ 3 x institutional ULN
    • Serum creatinine ≤ 1.5 times institutional ULN
  • Signed informed consent

Exclusion Criteria:

  • Prior chemotherapy for metastatic disease
  • Symptomatic brain metastases
  • Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
  • Requirement of concomitant treatment with a non-permitted medication, including high doses of vitamins and alternative drugs
  • History of allergic reactions to gemcitabine or egg
  • Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
  • Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
  • Pregnant or breastfeeding women
  • Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for three months after last treatment
  • Known positive status for HIV
  • Any reason why, in the investigator's opinion, the patient should not participate in the study.
  • Drug or alcohol abuse
  • Prior radical resection, but exploratory laparotomy as well palliative (e.g bypass) surgery are allowed
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913198


Locations
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Belgium
Clinique d'Oncologie Médicale, Institut Jules Bordet
Brussels, Belgium, 1000
Norway
Oslo University Hospital, The Norwegian Radium Hospital,
Oslo, Norway, 0310
Oslo University Hospital, Ullevål
Oslo, Norway, 0407
Sponsors and Collaborators
Clavis Pharma
More Information
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Responsible Party: Clavis Pharma
ClinicalTrials.gov Identifier: NCT00913198    
Other Study ID Numbers: CP4126-201
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012
Keywords provided by Clavis Pharma:
Pancreas
Advanced adenocarcinoma
CP-4126
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms