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Metastatic Pancreatic CancerPhase 2NCT03627390

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

A Phase 2 study testing BP-C1 and BP-C2 in people with Metastatic Pancreatic Cancer and Unresectable Pancreatic Cancer, run by Meabco A/S at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
BP-C1 and BP-C2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteEgypt
Study dates
19 Dec 2014to 4 Mar 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • National Liver Institute, Menoufia University

    Cairo

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
BP-C1, BP-C2
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
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BP-C1Drug

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

  • BP-C2Drug

    Also called molybdenum salts of benzene-polycarboxylic acids

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

Study groups in NCT03627390
Study groupRoleWhat they receive
BP-C1ExperimentalPatients will be treated with BP-C1 for 32 consecutive days
Receives: Drug: BP-C1
BP-C1+BP-C2ExperimentalPatients will be treated with BP-C1 and BP-C2 for 32 consecutive days
Receives: Drug: BP-C1; Drug: BP-C2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: baseline to Day 32 of treatment

  2. Maximum Common Toxicity Criteria (CTC) score

    Maximum CTC score will be recorded using NCI Common Toxicity Criteria v2.0 divided in 15 categories

    Measured: baseline to Day 32 of treatment

  3. Sum CTC score

    The Sum CTC score will be a sum of all registered CTC scores by 15 categories

    Measured: baseline to Day 32 of treatment

Secondary outcomes (3)

  1. 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.

    Measured: baseline to Day 32 of treatment

  2. 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"

    Measured: baseline to Day 16 and Day 32 of treatment

  3. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2018
  2. Study start19 Dec 2014
  3. Primary completion4 Mar 2016
  4. Study completion4 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open label, single center, two arm
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03627390
Sponsor's protocol ID
PaCa-BPC1/IIA
Status last verified
Nov 2018
First submitted
26 Jul 2018
Last updated
15 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BP-C1 and BP-C2 in people with Metastatic Pancreatic Cancer and Unresectable Pancreatic Cancer, run by Meabco A/S at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change (%) in the sum of diameters of target lesions (time frame: baseline to Day 32 of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03627390.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.

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