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

February 9, 2012 updated by: Clavis Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Clinique d'Oncologie Médicale, Institut Jules Bordet
  • Norway
      • Oslo, Norway, 0407
        • Oslo University Hospital, Ullevål
      • Oslo, Norway, 0310
        • Oslo University Hospital, The Norwegian Radium Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biological activity of CP-4126 in patients with advanced pancreatic cancer.
Time Frame: Every second cycle
Every second cycle

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival, Objective response rate.
Time Frame: Every second cycle - study length
Every second cycle - study length

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clavis Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

June 3, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (ESTIMATE)

June 4, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 10, 2012

Last Update Submitted That Met QC Criteria

February 9, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP4126-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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