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

Clavis Pharma

Status and phase: Completed; Phase 2

Conditions: Advanced Adenocarcinoma of Pancreas

Treatments: Drug: IV CP-4126

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913198

CP4126-201

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

IV CP-4126

Experimental group

Treatment:

Drug: IV CP-4126