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

NCT03627390 | Completed Phase 2

• 1 other identifier: PaCa-BPC1/IIA
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Treatment response

  baseline to Day 32 of treatment

• Scores of the general quality of life cancer questionnaire (EORTC QLQ-C30)

  baseline to Day 16 and Day 32 of treatment

• Number of registered adverse events

  screening to Day 32 of treatment and Day 28 of follow-up

Study Arms (2)

BP-C1

EXPERIMENTAL

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

Drug: BP-C1

BP-C1+BP-C2

EXPERIMENTAL

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

Drug: BP-C1; Drug: BP-C2

Interventions

BP-C1 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

Also known as: Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin, Benzene polycarboxylic acids complex with cis-diammineplatinum(II)

BP-C1; BP-C1+BP-C2

BP-C2 DRUG

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

Also known as: molybdenum salts of benzene-polycarboxylic acids

BP-C1+BP-C2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meabco A/S: lead
• Meddoc: collaborator
• Norwegian University of Life Sciences: collaborator

Study Sites (1)

National Liver Institute, Menoufia University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Tarek Ibrahim, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, single center, two arm

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 13, 2018
• Study Start: December 19, 2014
• Primary Completion: March 4, 2016
• Study Completion: March 4, 2016
• Last Updated: November 15, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)