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

November 13, 2018 updated by: Meabco A/S

The Effect of BP-C1 in Treatment of Inoperable Pancreatic Cancer Patients: A Single Centre Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt
        • National Liver Institute, Menoufia University

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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
Other Names:
  • Benzene polycarboxylic acids complex with cis-diammineplatinum(II)
  • Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin
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
Other Names:
  • Benzene polycarboxylic acids complex with cis-diammineplatinum(II)
  • Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin
Drug: BP-C2
BP-C2, 0.15% solution for oral use; 15 ml orally once daily for 32 consecutive days
Other Names:
  • molybdenum salts of benzene-polycarboxylic acids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change (%) in the sum of diameters of target lesions
Time Frame: baseline to Day 32 of treatment
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
Time Frame: baseline to Day 32 of treatment
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
Time Frame: baseline to Day 32 of treatment
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

Outcome Measure
Measure Description
Time Frame
Treatment response
Time Frame: baseline to Day 32 of treatment

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)
Time Frame: baseline to Day 16 and Day 32 of treatment
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
Time Frame: screening to Day 32 of treatment and Day 28 of follow-up
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

Collaborators and Investigators

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

Sponsor

Meabco A/S

Collaborators

Meddoc
Norwegian University of Life Sciences

Investigators

  • Principal Investigator: Tarek Ibrahim, MD, Department of HPH Surgery, National Liver Institute, University of Menoufia, Egypt

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 Major Dates

Study Start (Actual)

December 19, 2014

Primary Completion (Actual)

March 4, 2016

Study Completion (Actual)

March 4, 2016

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (Actual)

August 13, 2018

Study Record Updates

Last Update Posted (Actual)

November 15, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PaCa-BPC1/IIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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