Digestive System Diseases

All Conditions

Gastrointestinal Diseases

Antrodia cinnamomea and concomitant chemotherapy

Antrodia cinnamomea compounds of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days

AC-Can

Placebo of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days

placebo

Hsien-Hsueh E Chiu, MD

Pey-Harn Ywi-Chi, Bachelor

Kun-Ming Rau, MD

Yu-Chiang Hung, MD, PhD

The purpose of this study is to investigate if food supplements,Antrodia cinnamomea, could minimize the gastrointestinal symptom of cancer patients with chemotherapy.

In our unpublished report shows that patients who took Antrodia Cinnamomea compound of 15 milliliters liquid twice in a day, might help white blood cells, red blood cells and hemoglobin increase after 2 months; liver glutamic pyruvic transaminase(GPT) index mitigation, P \<0.05 difference statistically; In addition, liver glutamate oxaloacetate transaminase(GOT) and biochemical index of renal function had no abnormal data statistically. However, cancer patients with gastrointestinal disorders after chemotherapy is known to be a common side effect, we seek to investigate if Antrodia Cinnamomea improves the function of gastrointestinal system.

Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy

Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy- a Double Blinded, Randomized, Placebo-controlled Trial

Post-chemotherapy nausea, vomiting and epigastragia, etc. including gastrointestinal symptom/sign without mention above.

Life science related questionnairs visit 4 times just before treatment, after intervention 7 days, 30 days and 90 days.

New Bellus Enterprises

Chang Gung Memorial Hospital

Yu-Chiang Hung / MD, PhD

Oral qd, at least 30 minutes before breakfast

OB318 capsule

Ciao Hong

Lisa Liang

Ching-Liang Ho

Wei-Hong Cheng

The objectives of this Phase I study are to determine the maximum tolerable dose (MTD) and to evaluate pharmacokinetics (PK), safety/ tolerability and preliminary efficacy of OB318 in patients with advanced solid malignancies.

Evaluate Safety, Tolerability, PK, Preliminary Clinical Activity of OB318 in Patients With Advanced Solid Malignancies

A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Clinical Activity of OB318 in Patients With Advanced Solid Malignancies

NOTE: DLT is defined as any grade 3 or above toxicity by NCI-CTCAE version 4.03, as determined by the investigator and sponsor, to be at least possibly related in causality to the administered investigational product OB318 and will be observed during the 4 weeks of treatment for patients in the dose escalation phase.

NOTE:- MTD is defined as the prior dose level below the dose level at which 2/3 or 2/6 subjects suffer dose limiting toxicity (DLT) in the dose escalation phase

Laboratory safety tests will be performed at screening, baseline, Day 14 and Day 28 for the dose escalation, and at the last follow-up visit. For the extension phase, lab tests will be done before each 28 days cycle.

Physical examination will be performed at screening, baseline, and Day 28 for the dose escalation, and at the last follow-up visit. For the extension phase, physical examination will be done at last day of each cycle.

Vital signs will be performed at each study visit.

Electrocardiogram (ECG) is conducted at screening, baseline, Day 14 and Day 28 for the dose escalation, and at the last follow-up visit. For the extension phase, ECG will be conducted at the same time.

Imaging for tumor assessment will be made at screening, at the end of the treatment for the dose escalation and at the end of Cycle 2 for the extension phase.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy	NCT01287286	Neoplasm Functional Gast...	AC-Can placebo	18 Years - 80 Years	Chang Gung Memorial Hospital
Evaluate Safety, Tolerability, PK, Preliminary Clinical Activity of OB318 in Patients With Advanced Solid Malignancies	NCT02347228	Advanced Solid ...	OB318 capsule	20 Years -	Oneness Biotech Co., Ltd.
Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy	NCT01287286	Neoplasm Functional Gast...	AC-Can placebo	18 Years - 80 Years	Chang Gung Memorial Hospital

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