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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	26 June 2012
Main ID:	EUCTR2007-007476-42-SE
Date of registration:	05/11/2008
Prospective Registration:	Yes
Primary sponsor:	Clavis Pharma ASA
Public title:	A phase II study of CP-4126 in patients with advanced pancreatic cancer - CP4126-201
Scientific title:	A phase II study of CP-4126 in patients with advanced pancreatic cancer - CP4126-201
Date of first enrolment:	09/01/2009
Target sample size:	40
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007476-42
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
Phase:

Countries of recruitment
France	Sweden

Contacts

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Affiliation:

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Key inclusion & exclusion criteria

Inclusion criteria:
1. Histological or cytological confirmed advanced pancreatic cancer*
2. Not eligible for curative resection
3. Performance status (ECOG) 0-2
4. Estimated life expectancy of at least 12 weeks
5. Age = 18 years
6. Adequate haematological and biological functions:
• Bone marrow function:
a. Neutrophils = 1.5 x 109/L
b. Platelets > 100.0 x 109/L
c. Hb = 10 g/dL
• Hepatic function:
a. 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
b. Bilirubin = 1.5 times institutional ULN, if liver metastases = 3 x institutional ULN
• Renal function:
a. Serum creatinine = 1.5 times institutional ULN
7. Signed informed consent
*When feasible, the biopsy for diagnosis and hENT1 can be combined, so that the patient only needs to have one biopsy performed

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Prior chemotherapy for metastatic disease
2. Symptomatic brain metastases
3. Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
4. Requirement of concomitant treatment with a non-permitted medication, including high doses of vitamins and alternative drugs
5. History of allergic reactions to gemcitabine or egg
6. Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
7. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance
8. Pregnant or breastfeeding women
9. 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
10. Known positive status for HIV
11. Any reason why, in the investigator’s opinion, the patient should not participate in the study.
12. Drug or alcohol abuse
13. Prior radical resection, but exploratory laparotomy as well palliative (e.g. bypass) surgery are allowed

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Pancreatic Cancer

Intervention(s)

Product Name: CP-4126 for infusion
Product Code: CP-4126
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NA
CAS Number: 210829-30-4
Current Sponsor code: CP-4126
Other descriptive name: gemcitabine-5'-elaidate acid ester
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 15-

Primary Outcome(s)

Main Objective: The main objective is to assess the biological activity of CP-4126 in patients with advanced pancreatic cancer.

Primary end point(s): • Overall survival (OS); relation between hENT1 expression level and survival
• Objective response rate (ORR) according to Response Evaluation Criteria In Solid Tumours (RECIST) in patients with measurable disease. Changes in the tumour marker, CA19-9 will also be considered.
• Safety profile
• Feasibility: patient acceptance, biopsy sampling and analysis

Secondary Objective: Additional objectives is to assess

- the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival
- safety profile

Secondary Outcome(s)

Secondary ID(s)

CP4126-201

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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