Trial Outcomes & Findings for Belinostat in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery (NCT NCT00321594)

Last Updated: 2017-11-06

Results Overview

DLT is defined as any grade 4 hematological toxicity and any grade 3 or 4 non hematological toxicity during cycle 1, excluding alopecia. Specifically, grade 3 nausea, vomiting, or diarrhea that does not respond to therapy is considered dose-limiting. Also, delays in treatment greater than 2 weeks are also dose-limiting. MTD is defined as the dose below which \>= 2 of 3 or \>= 2 of 6 patients experience DLT. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

54 participants

Primary outcome timeframe

Course 1

Results posted on

2017-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Phase I, Level 1 Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. belinostat: Given IV Dose level: 600 mg/m2/day	Phase I, Level 2 Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. belinostat: Given IV Dose level: 900 mg/m2/day	Phase I, Level 3 Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. belinostat: Given IV Dose level: 1200 mg/m2/day	Phase I, Level 4 Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. belinostat: Given IV Dose level: 1400 mg/m2/day	Phase II, MTD Dose Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. belinostat: Given IV Dose level: 1400 mg/m2/day
Phase I, Level 1-4 STARTED	3	3	6	6	0
Phase I, Level 1-4 COMPLETED	3	3	6	6	0
Phase I, Level 1-4 NOT COMPLETED	0	0	0	0	0
Phase II, MTD Dose STARTED	0	0	0	6	36
Phase II, MTD Dose COMPLETED	0	0	0	6	36
Phase II, MTD Dose NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Belinostat in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I n=12 Participants Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. belinostat: Given IV Level 1: Dose: 600mg/m2/day Level 2: Dose: 900mg/m2/day Level 3: Dose: 1200mg/m2/day	Treatment (Enzyme Inhibitor Therapy) n=42 Participants Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. belinostat: Given IV Dose: 1400mg/m2/day	Total n=54 Participants Total of all reporting groups
Age, Continuous	54 year n=5 Participants	57.5 year n=7 Participants	56.5 year n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	38 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants	42 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Singapore	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment United States	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Hong Kong	10 participants n=5 Participants	34 participants n=7 Participants	44 participants n=5 Participants
Region of Enrollment South Korea	0 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Australia	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Course 1

Outcome measures

Outcome measures
Measure	Phase I, Level 3 n=6 Participants Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. belinostat: Given IV Dose: 1200mg/m2/day	Phase I, Level 4 n=6 Participants Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. belinostat: Given IV Dose: 1400mg/m2/day	Phase II, MTD n=3 Participants Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. belinostat: Given IV Dose: 1400mg/m2/day	Phase I, Level 2 n=3 Participants Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. belinostat: Given IV Dose: 900 mg/m2/day
Dose-limiting Toxicities (DLT) and Maximum Tolerated Dose (MTD) of Belinostat in Patients With Inoperable HCC (Phase I)	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Every 2 courses (approximately 6 weeks)

Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The 95% confidence intervals should be provided.