BP-C1 in Short-term Treatment of Metastatic Pancreatic Cancer

NCT ID: NCT03627390

Last Updated: 2018-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-19
• Study Completion Date: 2016-03-04

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.

Conditions

Metastatic Pancreatic Cancer; Unresectable Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BP-C1

Patients will be treated with BP-C1 for 32 consecutive days

Group Type: EXPERIMENTAL

BP-C1

Intervention Type: DRUG

BP-C1, 0.05% solution for injections; doses: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days

BP-C1+BP-C2

Patients will be treated with BP-C1 and BP-C2 for 32 consecutive days

Group Type: EXPERIMENTAL

BP-C1

Intervention Type: DRUG

BP-C1, 0.05% solution for injections; doses: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days

BP-C2

Intervention Type: DRUG

BP-C2, 0.15% solution for oral use; 15 ml orally once daily for 32 consecutive days

Interventions

BP-C1

BP-C1, 0.05% solution for injections; doses: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days

Intervention Type: DRUG

BP-C2

BP-C2, 0.15% solution for oral use; 15 ml orally once daily for 32 consecutive days

Intervention Type: DRUG

Other Intervention Names

Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin; Benzene polycarboxylic acids complex with cis-diammineplatinum(II); molybdenum salts of benzene-polycarboxylic acids

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meddoc

OTHER

Sponsor Role: collaborator

Norwegian University of Life Sciences

OTHER

Sponsor Role: collaborator

Meabco A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tarek Ibrahim, MD

Role: PRINCIPAL_INVESTIGATOR

Department of HPH Surgery, National Liver Institute, University of Menoufia, Egypt

Locations

National Liver Institute, Menoufia University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

PaCa-BPC1/IIA

Identifier Type: -

Identifier Source: org_study_id