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Completed

NCT Number: NCT01910597

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

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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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Songklanagarind Hospital, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

SBG

Drug

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

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

    baseline and then once every 2 months thereafter

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 29, 2013
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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