BP-C1 In Short-term Treatment Of Metastatic Pancreatic Cancer

Study Overview

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

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.

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.

Metastatic Pancreatic Cancer
Unresectable Pancreatic Cancer

DRUG: BP-C1
DRUG: BP-C2

PaCa-BPC1/IIA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-07-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-11-13
First Submitted that Met QC Criteria 2018-08-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-11-15
First Posted (ACTUAL) 2018-08-13	Results First Posted N/A	Last Verified 2018-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: BP-C1 Patients will be treated with BP-C1 for 32 consecutive days	DRUG: 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 DRUG: BP-C2 BP-C2, 0.15% solution for oral use; 15 ml orally once daily for 32 consecutive days
EXPERIMENTAL: BP-C1+BP-C2 Patients will be treated with BP-C1 and BP-C2 for 32 consecutive days	DRUG: 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 DRUG: BP-C2 BP-C2, 0.15% solution for oral use; 15 ml orally once daily for 32 consecutive days

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: BP-C1

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

DRUG: 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

DRUG: BP-C2

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

EXPERIMENTAL: BP-C1+BP-C2

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

DRUG: 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

DRUG: BP-C2

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

Primary Outcome Measures	Measure Description	Time Frame
Change (%) in the sum of diameters of target lesions	Diameter of target lesions will be measured by computer tomography (CT) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1	baseline to Day 32 of treatment
Maximum Common Toxicity Criteria (CTC) score	Maximum CTC score will be recorded using NCI Common Toxicity Criteria v2.0 divided in 15 categories	baseline to Day 32 of treatment
Sum CTC score	The Sum CTC score will be a sum of all registered CTC scores by 15 categories	baseline to Day 32 of treatment

Secondary Outcome Measures	Measure Description	Time Frame
Treatment response	In accordance with RECIST v1.1 the treatment response will be classified as 'complete response', 'partial response', 'stable disease' or 'progressive disease': Complete response (CR): disappearance of all target lesions. Partial response (PR): at least 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of diameters. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum might also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions will also be considered progression. Stable disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.	baseline to Day 32 of treatment
Scores of the general quality of life cancer questionnaire (EORTC QLQ-C30)	The EORTC QLQ-C30 is a general quality of life questionnaire for cancer patients. The questionnaire contains 30 questions. Three variables will be obtained from the EORTC QLQ-C30: the sum of scores C1 to C5 denoted as "Physical activity problem last week", the sum of scores C6 to C28 denoted as "Discomfort last week", and the sum of scores C29 and C30 denoted as "Health and quality of life"	baseline to Day 16 and Day 32 of treatment
Number of registered adverse events	Adverse events (AEs) will be coded according to the MedDRA (version 16.1E). AEs will be systemized by system organ class and by preferred term. AEs will be analyzed by severity, seriousness and relatedness to the drug.	screening to Day 32 of treatment and Day 28 of follow-up

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Meddoc
Norwegian University of Life Sciences

Investigators

PRINCIPAL_INVESTIGATOR: Tarek Ibrahim, MD, Department of HPH Surgery, National Liver Institute, University of Menoufia, Egypt

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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