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

Primary Purpose

Advanced Adenocarcinoma of Pancreas

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IV CP-4126
Sponsored by
Clavis Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Adenocarcinoma of Pancreas focused on measuring Pancreas, Advanced adenocarcinoma, CP-4126

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique d'Oncologie Médicale, Institut Jules Bordet
  • Oslo University Hospital, The Norwegian Radium Hospital,
  • Oslo University Hospital, Ullevål

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IV CP-4126

Arm Description

Outcomes

Primary Outcome Measures

Biological activity of CP-4126 in patients with advanced pancreatic cancer.

Secondary Outcome Measures

Overall survival, Objective response rate.

Full Information

First Posted
June 3, 2009
Last Updated
February 9, 2012
Sponsor
Clavis Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00913198
Brief Title
A Study of CP-4126 in Patients With Advanced Pancreatic Cancer
Official Title
A Phase II Study of CP-4126 in Patients With Advanced Pancreatic Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clavis Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Adenocarcinoma of Pancreas
Keywords
Pancreas, Advanced adenocarcinoma, CP-4126

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV CP-4126
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IV CP-4126
Intervention Description
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.
Primary Outcome Measure Information:
Title
Biological activity of CP-4126 in patients with advanced pancreatic cancer.
Time Frame
Every second cycle
Secondary Outcome Measure Information:
Title
Overall survival, Objective response rate.
Time Frame
Every second cycle - study length

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Clinique d'Oncologie Médicale, Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Oslo University Hospital, The Norwegian Radium Hospital,
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Facility Name
Oslo University Hospital, Ullevål
City
Oslo
ZIP/Postal Code
0407
Country
Norway

12. IPD Sharing Statement

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

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