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

NCT00913198 | Completed Phase 2

• 1 other identifier: CP4126-201
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 3

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.

Conditions

Advanced Adenocarcinoma of Pancreas

Keywords

Pancreas; Advanced adenocarcinoma; CP-4126

Outcome Measures

Primary Outcomes (1)

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

  Every second cycle

Secondary Outcomes (1)

• Overall survival, Objective response rate.

  Every second cycle - study length

Study Arms (1)

IV CP-4126

EXPERIMENTAL

Drug: IV CP-4126

Interventions

IV CP-4126 DRUG

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.

IV CP-4126

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clavis Pharma: lead

Study Sites (3)

Clinique d'Oncologie Médicale, Institut Jules Bordet

Brussels, 1000, Belgium

Location

Oslo University Hospital, The Norwegian Radium Hospital,

Oslo, 0310, Norway

Location

Oslo University Hospital, Ullevål

Oslo, 0407, Norway

Location

MeSH Terms

Interventions

CP 4126

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 4, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 10, 2012

Record last verified: 2012-02

Locations

BE (1); NO (2)