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

This study has been completed.
Information provided by (Responsible Party):
Clavis Pharma Identifier:
First received: June 3, 2009
Last updated: February 9, 2012
Last verified: February 2012
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 Intervention Phase
Advanced Adenocarcinoma of Pancreas Drug: IV CP-4126 Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Clavis Pharma:

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

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

Enrollment: 21
Study Start Date: April 2009
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

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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Please refer to this study by its identifier: NCT00913198

Clinique d'Oncologie Médicale, Institut Jules Bordet
Brussels, Belgium, 1000
Oslo University Hospital, The Norwegian Radium Hospital,
Oslo, Norway, 0310
Oslo University Hospital, Ullevål
Oslo, Norway, 0407
Sponsors and Collaborators
Clavis Pharma
  More Information

Responsible Party: Clavis Pharma Identifier: NCT00913198     History of Changes
Other Study ID Numbers: CP4126-201
Study First Received: June 3, 2009
Last Updated: February 9, 2012

Keywords provided by Clavis Pharma:
Advanced adenocarcinoma

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases processed this record on August 22, 2017