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CompletedNCT01910597Updated Oct 11, 2021

Phase I, Dose-Escalation Study of Soluble Beta-Glucan (SBG) in Patients With Advanced Solid Tumors

A Phase 1 interventional study of SBG in Advanced Solid Tumors, sponsored by Prince of Songkla University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-11.

Sponsored by Prince of Songkla University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

Soluble Beta-Glucan (SBG) is a compound prepared from commercial active dry Baker's yeast which is then proceeded through a multi-step laboratory processes invented by Prof. Rapepun Wititsuwannakul, Faculty of Science, Prince of Songkla University, Thailand. Based upon pre-clinical data, SBG has been shown to inhibit angiogenesis and probably enhance immune function, leading to shrinkage of tumor size in athymic nude mice injected by hepatocellular carcinoma cells (HepG2) and cervical cancer cells. Therefore, the investigators expect to see the safety and anti-cancer property of SBG in patients with advanced cancer whom no available therapy can be offered.

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Conditions studied

  • Advanced Solid Tumors
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In context

Lead sponsor

Prince of Songkla University is the lead sponsor of 112 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of histologically or cytologically documented, advanced-stage, primary or metastatic solid tumors that are refractory to standard therapy or for which no available standard therapy exists.
  • Evidence of measurable or evaluable disease.
  • Age must be at least 18 years.
  • ECOG performance status must be 0 or 2.
  • Received only best supportive care.
  • Patient must meet protocol-specified laboratory values.

Exclusion criteria

Exclusion Criteria:

  • Second primary cancer diagnosed within 5 years, except cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma which completed curative treatment.
  • Concurrent therapy with any other investigational agent.
  • Severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study-drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, make the subject inappropriate for this study.
  • Allergy to study drug.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    SBG

    Drug: SBG

Interventions

  • DrugSBG
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What researchers measure

Primary outcomes

  1. Dose limiting toxicity (DLT) to define the maximum tolerated dose (MTD). The DLT is defined as treatment related grade 3 or grade 4 adverse events or abnormal lab test that occurred in the first 28 days after start of study drug.

    Time frame: continuous monitoring for the first 28 days after start of the study medication

Secondary outcomes

  1. Antitumor activity by comparing baseline and post-treatment changes. Tumor assessment will be performed using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    baseline and then once every 2 months thereafter

    Time frame: baseline, month 2, month 4, month 6 and month 8

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Study locations

1 site
  • Songklanagarind Hospital, Prince of Songkla University
    Hat yai, Songkhla 90110, Thailand
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01910597
Lead sponsor
Prince of Songkla University
Responsible party
Arunee Dechaphunkul (Dr, Prince of Songkla University) — Principal investigator
First posted
Jul 29, 2013
Start date
Aug 1, 2013
Primary completion
Apr 20, 2016
Completion
Apr 20, 2016
Last update
Oct 11, 2021

Study contacts

Arunee Dechaphunkul, MD
principal investigator · Prince of Songkla University, Thailand

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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