TriangleNCT03989115 · 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: Study Day 1 - Study Day 28 (28 days)
What was measured
Any toxicities occurring during the DLT observation period (cycle 1) that were considered R/T study treatment, including GR4 AEs; GR3 febrile neutropenia or hemorrhage; GR3 thrombocytopenia with clinically significant bleeding; GR ≥2 pneumonitis; GR3 hypertension or rash which does not improve or remains uncontrolled for \>5 or more days despite maximal supportive care; GR3 non hematologic AEs that remain uncontrolled for \>72 hours despite maximal supportive care; Concurrent elevation of AST or ALT \>3 × ULN \& total bilirubin \>2 × ULN or international normalized ratio (INR) \>1.5 in the absence of cholestasis and other causes; Grade 3 QTcF prolongation based on a triplicate ECG; Ejection fraction \<50% with an absolute decrease of \>10% from baseline; Retinal vein occlusion any grade; 50% or less dose intensity of RMC4630 and/or cobimetnib or osimertinib due to study drug related toxicity. Refer to protocol for further details.
Analysis population: DLT-evaluable population was defined as the following: All treated participants in the dose escalation phase who completed the DLT period and received at least 75% of planned dose of RMC-4630 and cobimetinib or RMC-4630 and Osimertinib (ie, not have missed ≥3 doses of RMC-4630 and cobimetinib on the D1D2 intermittent schedule or ≥6 doses of cobimetinib on the 21 on/7 off schedule, or ≥8 doses for reasons other than toxicity) within the DLT observation period (i.e Cycle 1)
Groups in this outcome
Intermittent RMC-4630 (D1D4 or D1D2) + Daily Cobimetinib (QD21/7)
Participants who received intermittent dose of RMC-4630 80 mg or 140 mg on D1 and D4 or on D1 and D2 of a 28-day cycle and daily dose of Cobimetinib 20 mg or 40 mg from D1 through D21 and then 7 days off Cobimetinib from D22 to D28 of a 28-day cycle.
Intermittent RMC-4630 (D1D2) + Intermittent Cobimetinib (D1D2)
Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and intermittent dose of Cobimetinib 40 mg or 60 mg on D1 and D2 of a 28-day cycle.
Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)
Participants who received intermittent dose of RMC-4630 140 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle.
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)
Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle.
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)
Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 40mg D1 and D2 of a 28-day cycle.
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2
Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 60mg D1 and D2 of a 28-day cycle.
Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)
Participants who received intermittent dose of RMC-4630 100 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle.
Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)
Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle.
| Group | Source count |
|---|---|
| Intermittent RMC-4630 (D1D4 or D1D2) + Daily Cobimetinib (QD21/7) | 6 |
| Intermittent RMC-4630 (D1D2) + Intermittent Cobimetinib (D1D2) | 6 |
| Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7) | 9 |
| Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7) | 6 |
| Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2) | 5 |
| Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2 | 6 |
| Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD) | 4 |
| Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD) | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Intermittent RMC-4630 (D1D4 or D1D2) + Daily Cobimetinib (QD21/7) | 1 | Not reported | Not reported | Not reported | Not reported |
| Intermittent RMC-4630 (D1D2) + Intermittent Cobimetinib (D1D2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7) | 3 | Not reported | Not reported | Not reported | Not reported |
| Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7) | 1 | Not reported | Not reported | Not reported | Not reported |
| Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD) | 1 | Not reported | Not reported | Not reported | Not reported |
| Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD) | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 4
- units
- Participants
- description
- Any toxicities occurring during the DLT observation period (cycle 1) that were considered R/T study treatment, including GR4 AEs; GR3 febrile neutropenia or hemorrhage; GR3 thrombocytopenia with clinically significant bleeding; GR ≥2 pneumonitis; GR3 hypertension or rash which does not improve or remains uncontrolled for \>5 or more days despite maximal supportive care; GR3 non hematologic AEs that remain uncontrolled for \>72 hours despite maximal supportive care; Concurrent elevation of AST or ALT \>3 × ULN \& total bilirubin \>2 × ULN or international normalized ratio (INR) \>1.5 in the absence of cholestasis and other causes; Grade 3 QTcF prolongation based on a triplicate ECG; Ejection fraction \<50% with an absolute decrease of \>10% from baseline; Retinal vein occlusion any grade; 50% or less dose intensity of RMC4630 and/or cobimetnib or osimertinib due to study drug related toxicity. Refer to protocol for further details.
- groups
- description
- Participants who received intermittent dose of RMC-4630 80 mg or 140 mg on D1 and D4 or on D1 and D2 of a 28-day cycle and daily dose of Cobimetinib 20 mg or 40 mg from D1 through D21 and then 7 days off Cobimetinib from D22 to D28 of a 28-day cycle.
- id
- OG000
- title
- Intermittent RMC-4630 (D1D4 or D1D2) + Daily Cobimetinib (QD21/7)
- description
- Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and intermittent dose of Cobimetinib 40 mg or 60 mg on D1 and D2 of a 28-day cycle.
- id
- OG001
- title
- Intermittent RMC-4630 (D1D2) + Intermittent Cobimetinib (D1D2)
- description
- Participants who received intermittent dose of RMC-4630 140 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle.
- id
- OG002
- title
- Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)
- description
- Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle.
- id
- OG003
- title
- Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)
- description
- Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 40mg D1 and D2 of a 28-day cycle.
- id
- OG004
- title
- Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)
- description
- Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 60mg D1 and D2 of a 28-day cycle.
- id
- OG005
- title
- Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2
- description
- Participants who received intermittent dose of RMC-4630 100 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle.
- id
- OG006
- title
- Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)
- description
- Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle.
- id
- OG007
- title
- Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- DLT-evaluable population was defined as the following: All treated participants in the dose escalation phase who completed the DLT period and received at least 75% of planned dose of RMC-4630 and cobimetinib or RMC-4630 and Osimertinib (ie, not have missed ≥3 doses of RMC-4630 and cobimetinib on the D1D2 intermittent schedule or ≥6 doses of cobimetinib on the 21 on/7 off schedule, or ≥8 doses for reasons other than toxicity) within the DLT observation period (i.e Cycle 1)
- reporting Status
- POSTED
- time Frame
- Cycle 1: Study Day 1 - Study Day 28 (28 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