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Register:	EUCTR
Last refreshed on:	26 June 2012
Main ID:	EUCTR2007-007476-42-FR
Date of registration:	11/09/2009
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:	03/12/2009
Target sample size:	120
Recruitment status:	Authorised-recruitment may be ongoing or finished
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: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes 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 adenocarcinoma*
2. Pre-treatment serum CA 19-9 = 1.5 x ULN
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. Radical resection less than one year prior to inclusion in the study. 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-

Product Name: gemcitabine
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: gemcitabine
CAS Number: 95058-81-4
Current Sponsor code: gemcitabine

Primary Outcome(s)

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

Primary end point(s): • CA 19-9 responses

Secondary Objective: The correlation between hENT1 (human equilibrative nucleoside transporter 1) in tumour tissue and response will be measured as change in tumour marker CA 19-9 and objective response in addition to overall survival

Secondary Outcome(s)

Secondary ID(s)

CP4126-201

2007-007476-42-SE

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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