TriangleNCT01713582 · OUTCOME
Number of Participants With Dose Limiting Toxicities (DLTs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Cycle 1 (Up to 21 days)
What was measured
A DLT was graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.02 and defined as any of the following: grade 3 or 4 non-hematologic adverse events unless they were not optimally treated with supportive care; grade 3 or 4 asymptomatic laboratory abnormal values lasting \>7 days; prolonged grade 2 toxicity (lasting more than 2 weeks) leading to treatment interruption and/or dose reduction; pancytopenia with a hypocellular bone marrow and no marrow blasts lasting ≥6 weeks (AL participants); grade 3 neutropenia with fever or infection (OHM participants); grade 3 thrombocytopenia with bleeding (OHM participants); or grade 4 neutropenia or thrombocytopenia, regardless of symptoms and lasting ≥3 days (OHM participants).
Analysis population: All participants who received at least 85% of the intended dose of study therapy during the first cycle (i.e. \>12 days at full dose for AL and \>18 days at full dose for other hematological malignancies) or discontinued from the study due to a DLT attributable to study therapy.
Groups in this outcome
AL 10 mg QD 14-21
Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (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, twice a day (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 | 6 |
| AL 120 mg QD 14-21 | 6 |
| AL 120 mg QD 21-21 | 6 |
| AL 160 mg QD 14-21 | 6 |
| AML de Novo 80 mg QD 14-21 | 17 |
| AML/MDS 80 mg QD 14-21 | 14 |
| OHM 10 mg QD 21-21 | 3 |
| OHM 20 mg QD 21-21 | 3 |
| OHM 40 mg QD 21-21 | 3 |
| OHM 80 mg QD 21-21 | 7 |
| OHM 40 mg BID 21-21 | 6 |
| OHM 120 mg QD 21-21 | 6 |
| OHM 120 mg QD 14-21 | 3 |
| OHM 120 mg QD 5-7 | 4 |
| OHM 120 mg QD 7-21 | 5 |
| OHM/DLBCL 80 mg QD 14-21 | 14 |
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 | 0 | 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 | 0 | 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 | 2 | 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 | 1 | 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 | 2 | Not reported | Not reported | Not reported | Not reported |
| OHM 40 mg BID 21-21 | 5 | Not reported | Not reported | Not reported | Not reported |
| OHM 120 mg QD 21-21 | 4 | Not reported | Not reported | Not reported | Not reported |
| OHM 120 mg QD 14-21 | 2 | Not reported | Not reported | Not reported | Not reported |
| OHM 120 mg QD 5-7 | 3 | Not reported | Not reported | Not reported | Not reported |
| OHM 120 mg QD 7-21 | 2 | Not reported | Not reported | Not reported | Not reported |
| OHM/DLBCL 80 mg QD 14-21 | 0 | 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
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 1
- 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
- 6
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 17
- group Id
- OG010
- value
- 14
- group Id
- OG011
- value
- 3
- units
- Participants
- description
- A DLT was graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.02 and defined as any of the following: grade 3 or 4 non-hematologic adverse events unless they were not optimally treated with supportive care; grade 3 or 4 asymptomatic laboratory abnormal values lasting \>7 days; prolonged grade 2 toxicity (lasting more than 2 weeks) leading to treatment interruption and/or dose reduction; pancytopenia with a hypocellular bone marrow and no marrow blasts lasting ≥6 weeks (AL participants); grade 3 neutropenia with fever or infection (OHM participants); grade 3 thrombocytopenia with bleeding (OHM participants); or grade 4 neutropenia or thrombocytopenia, regardless of symptoms and lasting ≥3 days (OHM participants).
- groups
- description
- Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (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, twice a day (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
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who received at least 85% of the intended dose of study therapy during the first cycle (i.e. \>12 days at full dose for AL and \>18 days at full dose for other hematological malignancies) or discontinued from the study due to a DLT attributable to study therapy.
- reporting Status
- POSTED
- time Frame
- Cycle 1 (Up to 21 days)
- title
- Number of Participants With Dose Limiting Toxicities (DLTs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice