Clinical trial · Interventional
A Study of CP-4126 in Patients With Advanced Pancreatic Cancer
A Phase II Study of CP-4126 in Patients With Advanced Pancreatic Cancer.
NCT00913198CI-TRIAL-00006243completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Adenocarcinoma of Pancreas | Pancreatic Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IV CP-4126 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IV CP-4126
- interventionNames
- Drug: IV CP-4126
Primary outcomes (1)
- measure
- Biological activity of CP-4126 in patients with advanced pancreatic cancer.
- timeFrame
- Every second cycle
Secondary outcomes (1)
- measure
- Overall survival, Objective response rate.
- timeFrame
- Every second cycle - study length
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.