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A Study of Syngenon (BSG-001) for Inhalation in Subjects With Malignant Pleural Effusion and/or Malignant Ascites

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ClinicalTrials.gov Identifier: NCT03736122
Recruitment Status : Not yet recruiting
First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
BioSyngen Pte Ltd

Brief Summary:

Malignant pleural effusion and/ or malignant ascites is generally defined by presence of malignant cells in the effusion fluid. The first-line therapies are mostly intrusive, medically demanding and inefficient, and therefore, it is important to study and develop new therapeutic option to address the unmet need.

This protocol for BSG-001 is developed for the treatment of malignant pleural effusion and/ or malignant ascites. BSG-001 is an immune-modulator primarily exerts its effect via Toll-like receptor.

The purpose of this study is to assess the safety and tolerability of BSG-001. All eligible subjects will receive BSG-001 for at least 12 weeks (3 cycles).


Condition or disease Intervention/treatment Phase
Malignant Pleural Effusion Malignant Ascites Drug: BSG-001 Phase 1 Phase 2

Detailed Description:

This study is a phase 1/2a, single arm study with main purpose to evaluate the safety, tolerability and efficacy of BSG-001 in subjects with cancer that causes an abnormal amount of fluid to collect between the thin layers of tissue (pleura) lining the outside of the lung and the wall of the chest cavity, namely malignant pleural effusion and/ or subjects with cancer that causes the accumulation of fluid in the peritoneal cavity, causing abdominal swelling, namely malignant ascites.

The study aims to recruit 9 - 18 subjects in phase 1, and once the safety, tolerability and the preliminary efficacy of BSG-001 reach an optimal target exposure for recommended dose (RD), phase 2a will be opened for enrolment of approximately 40 subjects.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/IIa Study of Syngenon (BSG-001) for Inhalation in Subjects With Malignant Pleural Effusion and/or Malignant Ascites
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Experimental: BSG-001
Inhalation route, daily
Drug: BSG-001

BSG-001 is in solution form, 4mg per vial (2mg/mL) with Inhalation as route of administration using nebulizer.

BSG-001 will be administrated as an approximately 5 - 30 minutes inhalation session daily for 3 cycles (in repeated 28 days cycle).





Primary Outcome Measures :
  1. Safety and Tolerability of BSG-001 assessed with incidence of Treatment-Emergent Adverse Events (AEs) and Serious AEs [ Time Frame: From start of treatment throughout 12 weeks dosing ]
    Treatment-Emergent Adverse Events (AEs) and Serious AEs will be assessed by CTCAE v4.0 or higher version

  2. Efficacy of BSG-001 assessed with change in fluid volume of Malignant Pleural Effusion and/or Malignant Ascites [ Time Frame: From start of treatment throughout 12 weeks dosing, until disease progression and onward survival follow up up to 6 months or study completion, whichever came first. ]
    Efficacy of BSG-001 will be assessed with change in frequency and total change volume (for subjects require paracentesis and/or thoracentesis) and assessed by radiographic imaging (CT/ ultrasound) (for subjects without catheter drainage)


Secondary Outcome Measures :
  1. Recommended dose (RD) of BSG-001 [ Time Frame: Start of treatment throughout 28-day DLT dosing period ]
    RD will be assessed with incidence of BSG-001-related Adverse Events Grading during the dose limiting toxicity (DLT) period


Other Outcome Measures:
  1. Subjects' reported quality of life [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQLQ-30), version 3] [ Time Frame: From screening/ baseline, followed by Day 1 of every cycle prior to other procedures (each cycle is 28 days) for 3 cycles. ]
    Reported quality of life will be assessed through EORTC QLQ-30 questionnaire score change from baseline, by a four-point scale (first 28 questions) and a 7-point scale (last 2 questions) total of 30 questions, where higher score represents higher (better) response level. Calculation is based on linear transformation to standardise the raw score, so that scores range from 0 to 100.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically documented malignant pleural effusion and/or malignant ascites OR morphological diagnosis of malignant pleural effusion and/or malignant ascites by CT or ultrasound
  2. Histologically confirmed cancer
  3. Malignant pleural effusion and/or malignant ascites clinically judged as not responsive to conventional systemic therapy(ies) for primary malignancy
  4. Adequate liver and renal function as defined below:
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  6. Life expectancy of > 12 weeks
  7. Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
  8. Females of childbearing potential must have a negative serum pregnancy test at screening and be willing to have additional serum pregnancy tests during the study.
  9. Willing and able to comply with all study procedures

Exclusion Criteria:

  1. Presence of > grade 3 active infection or gastric bleeding at the time of screening
  2. Change in chemotherapy regimen within 28 days before Day 1 of study drug administration
  3. Concurrent use of any investigational product (IP) or investigational medicine within 28 days before Day 1 of study drug administration
  4. Symptomatic interstitial lung disease or inflammatory pneumonitis
  5. Concurrent disease or condition which, in the opinion of the Investigator, would pose a risk to patient safety or interfere with study participation or interpretation of individual patient results
  6. Breastfeeding at screening or planning to become pregnant (self or partner) at any time during study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736122


Contacts
Contact: Grace Khoo Koay (65) 6926 0818 clinicaltrials@biosg.com

Locations
Australia, South Australia
Flinders Medical Centre Not yet recruiting
Adelaide, South Australia, Australia, 5042
Contact: Kathrina Bartolay    +61 8 8404 2201    Kathrina.Bartolay@sa.gov.au   
Principal Investigator: Anand Rose, MD         
Sponsors and Collaborators
BioSyngen Pte Ltd
Investigators
Study Director: Lietao Li, MD BioSyngen Australia Pty Ltd

Responsible Party: BioSyngen Pte Ltd
ClinicalTrials.gov Identifier: NCT03736122     History of Changes
Other Study ID Numbers: BSG-001-001
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pleural Effusion
Ascites
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pathologic Processes
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms