TriangleNCT01713582 · OUTCOME
Number of Participants Whose Best Response Was Partial Response (PR) or Complete Response (CR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From time of first dose of study therapy until the end of treatment (up to 26 months)
What was measured
Best response was determined from the start of treatment until disease progression, recurrence, or completion of 26 months of treatment. Partial and complete response was assessed by bone marrow aspiration (AL participants); or computed tomography scan, magnetic resonance imaging, positron emission tomography, or X-ray (OHM participants) using standard criteria. Acute leukemia participants were assessed based on the recommendations from the European LeukemiaNet Döhner 2010); lymphoma participants according to Cheson 2007; and MM participants according to Durie 2006.
Analysis population: All participants who received one dose of study therapy and had at least one available tumor assessment by the end of Cycle 2 or later or with earlier evidence of response or progression.
Groups in this outcome
AL 10 mg QD 14-21
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
AL 20 mg QD 14-21
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
AL 40 mg QD 14-21
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
AL 20 mg BID 21-21
Participants received 20 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
AL 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
AL 40 mg BID 14-21
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
AL 120 mg QD 14-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
AL 120 mg QD 21-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
AL 160 mg QD 14-21
Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
AML de Novo 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
AML/MDS 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
OHM 10 mg QD 21-21
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
OHM 20 mg QD 21-21
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
OHM 40 mg QD 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
OHM 80 mg QD 21-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
OHM 40 mg BID 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
OHM 120 mg QD 21-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
OHM 120 mg QD 14-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
OHM 120 mg QD 5-7
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
OHM 120 mg QD 7-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
OHM/DLBCL 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
| Group | Source count |
|---|---|
| AL 10 mg QD 14-21 | 3 |
| AL 20 mg QD 14-21 | 3 |
| AL 40 mg QD 14-21 | 4 |
| AL 20 mg BID 21-21 | 3 |
| AL 80 mg QD 14-21 | 4 |
| AL 40 mg BID 14-21 | 8 |
| AL 120 mg QD 14-21 | 7 |
| AL 120 mg QD 21-21 | 6 |
| AL 160 mg QD 14-21 | 6 |
| AML de Novo 80 mg QD 14-21 | 18 |
| AML/MDS 80 mg QD 14-21 | 16 |
| OHM 10 mg QD 21-21 | 5 |
| OHM 20 mg QD 21-21 | 3 |
| OHM 40 mg QD 21-21 | 4 |
| OHM 80 mg QD 21-21 | 7 |
| OHM 40 mg BID 21-21 | 6 |
| OHM 120 mg QD 21-21 | 7 |
| OHM 120 mg QD 14-21 | 3 |
| OHM 120 mg QD 5-7 | 5 |
| OHM 120 mg QD 7-21 | 5 |
| OHM/DLBCL 80 mg QD 14-21 | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AL 10 mg QD 14-21 | 0 | Not reported | Not reported | Not reported | Not reported |
| AL 20 mg QD 14-21 | 0 | Not reported | Not reported | Not reported | Not reported |
| AL 40 mg QD 14-21 | 1 | Not reported | Not reported | Not reported | Not reported |
| AL 20 mg BID 21-21 | 0 | Not reported | Not reported | Not reported | Not reported |
| AL 80 mg QD 14-21 | 1 | Not reported | Not reported | Not reported | Not reported |
| AL 40 mg BID 14-21 | 0 | Not reported | Not reported | Not reported | Not reported |
| AL 120 mg QD 14-21 | 0 | Not reported | Not reported | Not reported | Not reported |
| AL 120 mg QD 21-21 | 0 | Not reported | Not reported | Not reported | Not reported |
| AL 160 mg QD 14-21 | 1 | Not reported | Not reported | Not reported | Not reported |
| AML de Novo 80 mg QD 14-21 | 0 | Not reported | Not reported | Not reported | Not reported |
| AML/MDS 80 mg QD 14-21 | 0 | Not reported | Not reported | Not reported | Not reported |
| OHM 10 mg QD 21-21 | 0 | Not reported | Not reported | Not reported | Not reported |
| OHM 20 mg QD 21-21 | 0 | Not reported | Not reported | Not reported | Not reported |
| OHM 40 mg QD 21-21 | 0 | Not reported | Not reported | Not reported | Not reported |
| OHM 80 mg QD 21-21 | 1 | Not reported | Not reported | Not reported | Not reported |
| OHM 40 mg BID 21-21 | 0 | Not reported | Not reported | Not reported | Not reported |
| OHM 120 mg QD 21-21 | 1 | Not reported | Not reported | Not reported | Not reported |
| OHM 120 mg QD 14-21 | 1 | Not reported | Not reported | Not reported | Not reported |
| OHM 120 mg QD 5-7 | 0 | Not reported | Not reported | Not reported | Not reported |
| OHM 120 mg QD 7-21 | 0 | Not reported | Not reported | Not reported | Not reported |
| OHM/DLBCL 80 mg QD 14-21 | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 18
- group Id
- OG010
- value
- 16
- group Id
- OG011
- value
- 5
- units
- Participants
- description
- Best response was determined from the start of treatment until disease progression, recurrence, or completion of 26 months of treatment. Partial and complete response was assessed by bone marrow aspiration (AL participants); or computed tomography scan, magnetic resonance imaging, positron emission tomography, or X-ray (OHM participants) using standard criteria. Acute leukemia participants were assessed based on the recommendations from the European LeukemiaNet Döhner 2010); lymphoma participants according to Cheson 2007; and MM participants according to Durie 2006.
- groups
- description
- Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
- id
- OG000
- title
- AL 10 mg QD 14-21
- description
- Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
- id
- OG001
- title
- AL 20 mg QD 14-21
- description
- Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
- id
- OG002
- title
- AL 40 mg QD 14-21
- description
- Participants received 20 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
- id
- OG003
- title
- AL 20 mg BID 21-21
- description
- Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
- id
- OG004
- title
- AL 80 mg QD 14-21
- description
- Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
- id
- OG005
- title
- AL 40 mg BID 14-21
- description
- Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
- id
- OG006
- title
- AL 120 mg QD 14-21
- description
- Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
- id
- OG007
- title
- AL 120 mg QD 21-21
- description
- Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
- id
- OG008
- title
- AL 160 mg QD 14-21
- description
- Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
- id
- OG009
- title
- AML de Novo 80 mg QD 14-21
- description
- Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
- id
- OG010
- title
- AML/MDS 80 mg QD 14-21
- description
- Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
- id
- OG011
- title
- OHM 10 mg QD 21-21
- param Type
- NUMBER
- population Description
- All participants who received one dose of study therapy and had at least one available tumor assessment by the end of Cycle 2 or later or with earlier evidence of response or progression.
- reporting Status
- POSTED
- time Frame
- From time of first dose of study therapy until the end of treatment (up to 26 months)
- title
- Number of Participants Whose Best Response Was Partial Response (PR) or Complete Response (CR)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice