Trial Outcomes & Findings for Phase I Study of OPB-51602 in Patients With Hematologic Malignancies (NCT NCT01344876)
NCT ID: NCT01344876
Last Updated: 2015-06-08
Results Overview
Treatment emergent adverse events observed during outcome measure time frame. A Treatment Emergent Adverse Event was defined as an AE occurring after the start of IMP administration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)
Results posted on
2015-06-08
Participant Flow
Participant milestones
| Measure |
OPB-51602: 1mg/Day
OPB-51602: 1, 2, 3,4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602: 2mg/Day
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602: 3mg/Day
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602: 4mg/Day
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602: 6mg/Day
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
4
|
6
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
OPB-51602: 1mg/Day
OPB-51602: 1, 2, 3,4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602: 2mg/Day
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602: 3mg/Day
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602: 4mg/Day
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602: 6mg/Day
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Definite progression of primary disease
|
1
|
0
|
0
|
3
|
0
|
Baseline Characteristics
Phase I Study of OPB-51602 in Patients With Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
OPB-51602
n=20 Participants
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
OPB-51602: once daily during the treatment period
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=93 Participants
|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 6.5 • n=93 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
|
Region of Enrollment
Japan
|
20 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)Population: Safety population No statistical analysis provided for Subjects With Treatment Emergent Adverse Events.
Treatment emergent adverse events observed during outcome measure time frame. A Treatment Emergent Adverse Event was defined as an AE occurring after the start of IMP administration.
Outcome measures
| Measure |
OPB-51602
n=20 Participants
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
OPB-51602: once daily during the treatment period
|
OPB-51602 2mg/Day
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602 3mg/Day
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602 4mg/Day
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602 6mg/Day
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
|---|---|---|---|---|---|
|
Subjects With Treatment Emergent Adverse Events
|
20 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)Population: DLT evaluated subjects who had achieved ≧75% study drug compliance during a 4-week (28-day) treatment period starting from Day 4. No statistical analysis provided for Subjects With DLTs.
DLT was defined as adverse events occurring during Cycle 1 and: (1) Grade 3 or higher nausea, vomiting, or diarrhea despite the use of anti-emetic or antidiarrheal drugs, (2) Grade 3 or higher non-hematologic toxicity, excluding alopecia, (3) AEs requiring interruption of the IMP for a total of 8 days or longer, (4) Grade 4 neutropenia lasting ≥ 8 days (not applicable for leukemia), (5) Grade 3 or higher febrile neutropenia or infection due to neutropenia (not applicable for leukemia), (6) Grade 4 thrombocytopenia or Grade 3 thrombocytopenia requiring platelet transfusion (not applicable for leukemia).
Outcome measures
| Measure |
OPB-51602
n=4 Participants
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
OPB-51602: once daily during the treatment period
|
OPB-51602 2mg/Day
n=3 Participants
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602 3mg/Day
n=4 Participants
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602 4mg/Day
n=6 Participants
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602 6mg/Day
n=3 Participants
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From first dose of study medication to withdrawal examinationPopulation: Efficacy population included all treated subjects who had received at least 1 dose of study drug. No statistical analysis provided for treatment response.
Assessment of the treatment response was evaluated according to internationally recognized response criteria for multiple myeloma, non-Hodgkin's lymphoma, acute myeloid leukemia, chronic myeloid leukemia. "Response" was defined as at least partial response or partial remission (PR) according to the criteria for efficacy assessment.
Outcome measures
| Measure |
OPB-51602
n=20 Participants
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
OPB-51602: once daily during the treatment period
|
OPB-51602 2mg/Day
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602 3mg/Day
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602 4mg/Day
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602 6mg/Day
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
|---|---|---|---|---|---|
|
Treatment Response
|
0 participants
|
—
|
—
|
—
|
—
|
Adverse Events
OPB-51602 1mg/Day
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
OPB-51602 2mg/Day
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
OPB-51602 3mg/Day
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
OPB-51602 4mg/Day
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
OPB-51602 6mg/Day
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OPB-51602 1mg/Day
n=4 participants at risk
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602 2mg/Day
n=3 participants at risk
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602 3mg/Day
n=4 participants at risk
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602 4mg/Day
n=6 participants at risk
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602 6mg/Day
n=3 participants at risk
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/3 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/4 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/6 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/3 • From first dose of study medication to 30 days after last dose of study medication.
|
|
General disorders
Fatigue
|
0.00%
0/4 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/3 • From first dose of study medication to 30 days after last dose of study medication.
|
25.0%
1/4 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/6 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/3 • From first dose of study medication to 30 days after last dose of study medication.
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/3 • From first dose of study medication to 30 days after last dose of study medication.
|
25.0%
1/4 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/6 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/3 • From first dose of study medication to 30 days after last dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/3 • From first dose of study medication to 30 days after last dose of study medication.
|
25.0%
1/4 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/6 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/3 • From first dose of study medication to 30 days after last dose of study medication.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/3 • From first dose of study medication to 30 days after last dose of study medication.
|
25.0%
1/4 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/6 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/3 • From first dose of study medication to 30 days after last dose of study medication.
|
|
Nervous system disorders
Spinal cord infarction
|
25.0%
1/4 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/3 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/4 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/6 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/3 • From first dose of study medication to 30 days after last dose of study medication.
|
Other adverse events
| Measure |
OPB-51602 1mg/Day
n=4 participants at risk
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602 2mg/Day
n=3 participants at risk
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602 3mg/Day
n=4 participants at risk
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602 4mg/Day
n=6 participants at risk
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
OPB-51602 6mg/Day
n=3 participants at risk
OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/3 • From first dose of study medication to 30 days after last dose of study medication.
|
50.0%
2/4 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
2/6 • Number of events 4 • From first dose of study medication to 30 days after last dose of study medication.
|
66.7%
2/3 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 7 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
1/3 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
100.0%
4/4 • Number of events 5 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
2/6 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
1/3 • Number of events 3 • From first dose of study medication to 30 days after last dose of study medication.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
1/3 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
25.0%
1/4 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
50.0%
3/6 • Number of events 3 • From first dose of study medication to 30 days after last dose of study medication.
|
100.0%
3/3 • Number of events 6 • From first dose of study medication to 30 days after last dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
1/3 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
25.0%
1/4 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
2/6 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
66.7%
2/3 • Number of events 4 • From first dose of study medication to 30 days after last dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From first dose of study medication to 30 days after last dose of study medication.
|
66.7%
2/3 • Number of events 4 • From first dose of study medication to 30 days after last dose of study medication.
|
50.0%
2/4 • Number of events 3 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/6 • From first dose of study medication to 30 days after last dose of study medication.
|
66.7%
2/3 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
|
General disorders
Malaise
|
0.00%
0/4 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/3 • From first dose of study medication to 30 days after last dose of study medication.
|
50.0%
2/4 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
2/6 • Number of events 5 • From first dose of study medication to 30 days after last dose of study medication.
|
100.0%
3/3 • Number of events 3 • From first dose of study medication to 30 days after last dose of study medication.
|
|
General disorders
Fatigue
|
0.00%
0/4 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
1/3 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
50.0%
2/4 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/6 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
1/3 • Number of events 5 • From first dose of study medication to 30 days after last dose of study medication.
|
|
Investigations
Neutrophil count decreased
|
50.0%
2/4 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/3 • From first dose of study medication to 30 days after last dose of study medication.
|
25.0%
1/4 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
66.7%
4/6 • Number of events 6 • From first dose of study medication to 30 days after last dose of study medication.
|
66.7%
2/3 • Number of events 3 • From first dose of study medication to 30 days after last dose of study medication.
|
|
Investigations
White blood cell count decreased
|
50.0%
2/4 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
1/3 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
25.0%
1/4 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
50.0%
3/6 • Number of events 4 • From first dose of study medication to 30 days after last dose of study medication.
|
66.7%
2/3 • Number of events 4 • From first dose of study medication to 30 days after last dose of study medication.
|
|
Investigations
Lymphocyte count decreased
|
50.0%
2/4 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
1/3 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
50.0%
2/4 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
2/6 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
1/3 • Number of events 3 • From first dose of study medication to 30 days after last dose of study medication.
|
|
Investigations
Platelet count decreased
|
50.0%
2/4 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/3 • From first dose of study medication to 30 days after last dose of study medication.
|
25.0%
1/4 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
2/6 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
1/3 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
1/3 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
25.0%
1/4 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
16.7%
1/6 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
1/3 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
1/3 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
50.0%
2/4 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
50.0%
3/6 • Number of events 3 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/3 • From first dose of study medication to 30 days after last dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • From first dose of study medication to 30 days after last dose of study medication.
|
66.7%
2/3 • Number of events 4 • From first dose of study medication to 30 days after last dose of study medication.
|
25.0%
1/4 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
0.00%
0/6 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
1/3 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
1/3 • Number of events 1 • From first dose of study medication to 30 days after last dose of study medication.
|
75.0%
3/4 • Number of events 3 • From first dose of study medication to 30 days after last dose of study medication.
|
33.3%
2/6 • Number of events 2 • From first dose of study medication to 30 days after last dose of study medication.
|
100.0%
3/3 • Number of events 3 • From first dose of study medication to 30 days after last dose of study medication.
|
Additional Information
Leader of Department of "Small Global" Clinical Development
Otsuka Pharmaceutical Co., Ltd
Phone: +81-3-6361-7366
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place