Clinical trial NCT03627390: BP-C1 in Short-term Treatment of Metastatic Pancreatic Cancer
Official title: The Effect of BP-C1 in Treatment of Inoperable Pancreatic Cancer Patients: A Single Centre Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Cancer
Unresectable Pancreatic Cancer
Keywords: Benzene polycarboxylic acids complex with cis-diammineplatinum(II)
BP-C1
Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin
Platinum analogue
Metronomic chemotherapy
Cisplatin
Pancreatic cancer
BP-C2
molybdenum salts of benzene-polycarboxylic acids
Lead sponsor: Meabco A/S
Sponsor class: INDUSTRY
Collaborators: name: Meddoc
name: Norwegian University of Life Sciences
First posted: 2018-08-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label, single center, two arm
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: BP-C1, solution for injections 0.05%, is currently being developed for treatment of patients with metastatic breast cancer and metastatic pancreatic cancer with palliative intent. Active substance of the product, which is a novel platinum-containing anticancer agent developed for intramuscular administration, is a complex between cis-diammineplatinum(II) derived core and an amphiphilic polymer, containing a composition of benzene polycarboxylic acids. The amphiphilic characteristics of the polymer have resulted in a product with clear and significantly altered and improved properties compared to other platinum analogues, e.g. cisplatin, carboplatin and oxaliplatin.

BP-C1 preserves antitumour activity of its predecessors (e.g. cisplatin and carboplatin), additionally offering the following advantages that ensure favourable outcome of treatment in metastatic cancer patients:

* injectable solution (intramuscular) does not cause injection site reactions;
* can be administered at home by a nurse or a patient;
* has an improved pharmacokinetic profile;
* exerts an additional immunomodulatory activity.

BP-C2 is a novel lignin-derived polyphenolic composition with ammonium molybdate. BP-C2, given orally, is believed to reduce the toxicity of chemotherapeutic agents.

This is a single center, two arm, open label pilot study (phase IIa). The eligible patients will be allocated either to BP-C1 arm or to BP-C1+BP-C2 arm and treated for 32 days with further follow-up for 28 days.

Eligibility criteria: 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.

Primary outcomes:
measure: Change (%) in the sum of diameters of target lesions
timeFrame: baseline to Day 32 of treatment
measure: Maximum Common Toxicity Criteria (CTC) score
timeFrame: baseline to Day 32 of treatment
measure: Sum CTC score
timeFrame: baseline to Day 32 of treatment
Secondary outcomes:
measure: Treatment response
timeFrame: baseline to Day 32 of treatment
measure: Scores of the general quality of life cancer questionnaire (EORTC QLQ-C30)
timeFrame: baseline to Day 16 and Day 32 of treatment
measure: Number of registered adverse events
timeFrame: screening to Day 32 of treatment and Day 28 of follow-up
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Liver Institute, Menoufia University
Study officials:
affiliation: Department of HPH Surgery, National Liver Institute, University of Menoufia, Egypt
name: Tarek Ibrahim, MD
role: PRINCIPAL_INVESTIGATOR
References: