Status:
COMPLETED
Phase I, Dose-Escalation Study of Soluble Beta-Glucan (SBG) in Patients With Advanced Solid Tumors
Lead Sponsor:
Prince of Songkla University
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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, F...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01910597
Start Date
August 1 2013
End Date
April 20 2016
Last Update
October 11 2021
Active Locations (1)
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1
Songklanagarind Hospital, Prince of Songkla University
Hat Yai, Changwat Songkhla, Thailand, 90110