Trial Outcomes & Findings for Belinostat in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery (NCT NCT00321594)
NCT ID: 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
| 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
| 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=99 Participants
|
57.5 year
n=107 Participants
|
56.5 year
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Singapore
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Hong Kong
|
10 participants
n=99 Participants
|
34 participants
n=107 Participants
|
44 participants
n=206 Participants
|
|
Region of Enrollment
South Korea
|
0 participants
n=99 Participants
|
5 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Course 1DLT 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.
Outcome measures
| Measure |
Phase I, Level 1
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: 600 mg/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
|
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
|
|---|---|---|---|---|
|
Dose-limiting Toxicities (DLT) and Maximum Tolerated Dose (MTD) of Belinostat in Patients With Inoperable HCC (Phase I)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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.
Outcome measures
| Measure |
Phase I, Level 1
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: 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: 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: 1200mg/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: 1400mg/m2/day
|
|---|---|---|---|---|
|
Tumor Response in Patients With Inoperable HCC Using Belinostat (Phase II)
Partial Response
|
1 Participants
|
—
|
—
|
—
|
|
Tumor Response in Patients With Inoperable HCC Using Belinostat (Phase II)
Stable disease
|
19 Participants
|
—
|
—
|
—
|
|
Tumor Response in Patients With Inoperable HCC Using Belinostat (Phase II)
Progressive disease
|
22 Participants
|
—
|
—
|
—
|
Adverse Events
Phase I, Level 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1, Level 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase I, Level 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase I, Level 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase II, MTD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Winnie Yeo
Department of Clinical Oncology, The Chinese University of Hong Kong
Phone: 852-2632
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60