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

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: SBG

• Registration Number: NCT01910597
• Lead Sponsor: Prince of Songkla University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-07-25
• Study First Posted: 2013-07-29
• Study Start: 2013-08-01
• Primary Completion: 2016-04-20
• Study Completion: 2016-04-20
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-03
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBG	SBG	-

Primary Outcome Measures

Name	Time	Method
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.	continuous monitoring for the first 28 days after start of the study medication

Secondary Outcome Measures

Name	Time	Method
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, month 2, month 4, month 6 and month 8	baseline and then once every 2 months thereafter

Trial Locations

Locations (1)

Songklanagarind Hospital, Prince of Songkla University; 🇹🇭 Hat yai, Songkhla, Thailand