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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clavis Pharma
ClinicalTrials.gov Identifier:
NCT00913198
First received: June 3, 2009
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival, Objective response rate. [ Time Frame: Every second cycle - study length ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913198

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

No publications provided

Responsible Party: Clavis Pharma
ClinicalTrials.gov Identifier: NCT00913198     History of Changes
Other Study ID Numbers: CP4126-201
Study First Received: June 3, 2009
Last Updated: February 9, 2012
Health Authority: Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency

Keywords provided by Clavis Pharma:
Pancreas
Advanced adenocarcinoma
CP-4126

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Cystic, Mucinous, and Serous
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013