Clinical trial · Interventional
BP-C1 in Short-term Treatment of Metastatic Pancreatic Cancer
The Effect of BP-C1 in Treatment of Inoperable Pancreatic Cancer Patients: A Single Centre Pilot Study
NCT03627390CI-TRIAL-00035794completedPhase 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 aim of this study is to investigate the short-term effect and tolerability BP-C1 in patients with metastatic pancreatic cancer who has undergone guideline-recommended chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Unresectable Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BP-C1 | Drug | — | UNRESOLVED |
| BP-C2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BP-C1
- description
- Patients will be treated with BP-C1 for 32 consecutive days
- interventionNames
- Drug: BP-C1
- type
- EXPERIMENTAL
- label
- BP-C1+BP-C2
- description
- Patients will be treated with BP-C1 and BP-C2 for 32 consecutive days
- interventionNames
- Drug: BP-C1
- Drug: BP-C2
Primary outcomes (3)
- measure
- Change (%) in the sum of diameters of target lesions
- timeFrame
- baseline to Day 32 of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients of all genders between 18 and 80 years of age with metastatic pancreatic cancer (unresectable pancreatic cancer with increased levels of cancer antigen 19-9), who had an expected survival time of at least 3 months. Exclusion Criteria: Patients fulfilling at least one of the following criteria will be excluded from participation in the study: * Abnormal liver function classified as total bilirubin \>136 μmol/L (8.0 mg/dL) * Abnormal kidney function defined by serum creatinine \>120 μmol/L (1.5 mg/dL). * Abnormal coagulation capacity defined by the relative arbitrary concentration of coagulation factors 2,7,10 \< 0.7 or international normalized ratio \>1.5. * Verified metastases to the brain. * Synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer. * Abnormal haematology status defined by hemoglobin \< 6.0 g/dL, platelet count \< 100,000/mm\^3 or leucocytes \< 3 x 10\^9/L. * Clinically significant abnormal ECG. * Karnofsky performance status score \<60%. * Pregnancy or breast-feeding. * Women of fertile age who do not want to be tested for possible pregnancy. * Uncontrolled bacterial, viral, fungal or parasite infection. * Under systemic treatment with corticosteroids or other immunosuppressive drugs in the last 21 days before start of the trial treatment. * Participating in another clinical trial with pharmaceuticals in the last six weeks before start of this trial treatment. * Not able to understand information. * Not willing or not able to give written consent to participate in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.