TriangleNCT02347917 · OUTCOME
Best Overall Response
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
- Every 6 weeks from the first dose of BBI608 until Week 30, and every 9 weeks from Week 31.
What was measured
The best overall response is the best response recorded from the start of the study treatment until the end of treatment. The RECIST 1.1 was used for the evaluation of tumor response and overall response in patients with NSCLC, and also the evaluation of any non-pleural lesions in patients with MPM. The mRECIST was used for the evaluation of tumor response and overall response in patients with MPM. The result of imaging assessment by study site was used for phase 1 part, and the result of imaging assessment by the imaging assessment committee was used for phase 2 part.
Analysis population: modified ITT population. Efficacy was analyzed using the efficacy analysis population (i.e., modified ITT population; mITT), separately for Phase 1 part (n=4), Phase 2 part (n=24) and Phase 2 part including 1 participant with MPM in Phase 1 part (n=25).
Groups in this outcome
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
MPM: BBI608 + Pem +CDDP (Phase 1 Part)
Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including Participants With MPM in Phase 1 Part)
Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
| Group | Source count |
|---|---|
| NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 3 |
| MPM: BBI608 + Pem +CDDP (Phase 1 Part) | 1 |
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 4 |
| MPM: BBI608 + Pem + CDDP (Phase 2 Part) | 24 |
| MPM: BBI608 + Pem + CDDP (Phase 2 Part Including Participants With MPM in Phase 1 Part) | 25 |
Reported measurements
Source class 1
Complete response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
| MPM: BBI608 + Pem +CDDP (Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
| MPM: BBI608 + Pem + CDDP (Phase 2 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
| MPM: BBI608 + Pem + CDDP (Phase 2 Part Including Participants With MPM in Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
Partial response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
| MPM: BBI608 + Pem +CDDP (Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
| MPM: BBI608 + Pem + CDDP (Phase 2 Part) | 8 | Not reported | Not reported | Not reported | Not reported |
| MPM: BBI608 + Pem + CDDP (Phase 2 Part Including Participants With MPM in Phase 1 Part) | 8 | Not reported | Not reported | Not reported | Not reported |
Stable disease (SD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 3 | Not reported | Not reported | Not reported | Not reported |
| MPM: BBI608 + Pem +CDDP (Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 3 | Not reported | Not reported | Not reported | Not reported |
| MPM: BBI608 + Pem + CDDP (Phase 2 Part) | 11 | Not reported | Not reported | Not reported | Not reported |
| MPM: BBI608 + Pem + CDDP (Phase 2 Part Including Participants With MPM in Phase 1 Part) | 11 | Not reported | Not reported | Not reported | Not reported |
Progressive disease (PD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
| MPM: BBI608 + Pem +CDDP (Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
| MPM: BBI608 + Pem + CDDP (Phase 2 Part) | 2 | Not reported | Not reported | Not reported | Not reported |
| MPM: BBI608 + Pem + CDDP (Phase 2 Part Including Participants With MPM in Phase 1 Part) | 2 | Not reported | Not reported | Not reported | Not reported |
Not evaluated (NE)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
| MPM: BBI608 + Pem +CDDP (Phase 1 Part) | 1 | Not reported | Not reported | Not reported | Not reported |
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 1 | Not reported | Not reported | Not reported | Not reported |
| MPM: BBI608 + Pem + CDDP (Phase 2 Part) | 3 | Not reported | Not reported | Not reported | Not reported |
| MPM: BBI608 + Pem + CDDP (Phase 2 Part Including Participants With MPM in Phase 1 Part) | 4 | 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
- title
- Complete response (CR)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 8
- title
- Partial response (PR)
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 11
- title
- Stable disease (SD)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 2
- title
- Progressive disease (PD)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- title
- Not evaluated (NE)
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 24
- group Id
- OG004
- value
- 25
- units
- Participants
- description
- The best overall response is the best response recorded from the start of the study treatment until the end of treatment. The RECIST 1.1 was used for the evaluation of tumor response and overall response in patients with NSCLC, and also the evaluation of any non-pleural lesions in patients with MPM. The mRECIST was used for the evaluation of tumor response and overall response in patients with MPM. The result of imaging assessment by study site was used for phase 1 part, and the result of imaging assessment by the imaging assessment committee was used for phase 2 part.
- groups
- description
- Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
- id
- OG000
- title
- NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
- description
- Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
- id
- OG001
- title
- MPM: BBI608 + Pem +CDDP (Phase 1 Part)
- description
- Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
- id
- OG002
- title
- MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
- description
- Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
- id
- OG003
- title
- MPM: BBI608 + Pem + CDDP (Phase 2 Part)
- description
- Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
- id
- OG004
- title
- MPM: BBI608 + Pem + CDDP (Phase 2 Part Including Participants With MPM in Phase 1 Part)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- modified ITT population. Efficacy was analyzed using the efficacy analysis population (i.e., modified ITT population; mITT), separately for Phase 1 part (n=4), Phase 2 part (n=24) and Phase 2 part including 1 participant with MPM in Phase 1 part (n=25).
- reporting Status
- POSTED
- time Frame
- Every 6 weeks from the first dose of BBI608 until Week 30, and every 9 weeks from Week 31.
- title
- Best Overall Response
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice