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

NCT01910597 | Completed Phase 1

• 1 other identifier: 552941411
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

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.

  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, month 2, month 4, month 6 and month 8

Study Arms (1)

SBG

EXPERIMENTAL

Drug: SBG

Interventions

SBG DRUG

SBG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Songklanagarind Hospital, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Study Officials

• Arunee Dechaphunkul, MD

  Prince of Songkla University, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 29, 2013
• Study Start: August 1, 2013
• Primary Completion: April 20, 2016
• Study Completion: April 20, 2016
• Last Updated: October 11, 2021

Record last verified: 2021-10

Locations

TH (1)