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

Phase 2

Completed

• Conditions: Advanced Adenocarcinoma of Pancreas
• Interventions: Drug: IV CP-4126

• Registration Number: NCT00913198
• Lead Sponsor: Clavis Pharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-06-03
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Primary Completion: 2011-06
• Study Completion: 2011-09
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-09
• Last Update Posted: 2012-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IV CP-4126	IV CP-4126	-

Primary Outcome Measures

Name	Time	Method
Biological activity of CP-4126 in patients with advanced pancreatic cancer.	Every second cycle

Secondary Outcome Measures

Name	Time	Method
Overall survival, Objective response rate.	Every second cycle - study length

Trial Locations

Locations (3)

Clinique d'Oncologie Médicale, Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Oslo University Hospital, Ullevål; 🇳🇴 Oslo, Norway

Oslo University Hospital, The Norwegian Radium Hospital,; 🇳🇴 Oslo, Norway