TriangleNCT00939770 · OUTCOME
Number of Participants With Toxicities of Crizotinib
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
- Up to 30 days post-treatment
What was measured
The descriptions and grading scales found in the revised NCI CTCAE version 4.0 will be utilized for AE reporting.
Analysis population: All patients included in analysis
Groups in this outcome
Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
Phase 1: Part A:PF-02341066 130 mg/m²/Dose BID
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
Phase 1: Part A:PF-02341066 165 mg/m²/Dose BID
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
Phase 1: Part A:PF-02341066 215 mg/m²/Dose BID
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
Phase 1: Part A:PF-02341066 280 mg/m²/Dose BID
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
Phase 1: Part A: PF-02341066 365 mg/m²/Dose BID
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
Phase 2: Part B: PF-02341066 280 mg/m2/Dose BID
Part B: Patients with ALK+ relapsed/refractory neuroblastoma
Phase 2:Part C: PF-02341066 280 mg/m2/Dose BID
Part C: Patients with ALK+ relapsed/refractory ALCL
| Group | Source count |
|---|---|
| Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID | 6 |
| Phase 1: Part A:PF-02341066 130 mg/m²/Dose BID | 8 |
| Phase 1: Part A:PF-02341066 165 mg/m²/Dose BID | 23 |
| Phase 1: Part A:PF-02341066 215 mg/m²/Dose BID | 12 |
| Phase 1: Part A:PF-02341066 280 mg/m²/Dose BID | 38 |
| Phase 1: Part A: PF-02341066 365 mg/m²/Dose BID | 11 |
| Phase 2: Part B: PF-02341066 280 mg/m2/Dose BID | 14 |
| Phase 2:Part C: PF-02341066 280 mg/m2/Dose BID | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Part A:PF-02341066 130 mg/m²/Dose BID | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Part A:PF-02341066 165 mg/m²/Dose BID | 23 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Part A:PF-02341066 215 mg/m²/Dose BID | 11 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Part A:PF-02341066 280 mg/m²/Dose BID | 38 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Part A: PF-02341066 365 mg/m²/Dose BID | 11 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Part B: PF-02341066 280 mg/m2/Dose BID | 14 | Not reported | Not reported | Not reported | Not reported |
| Phase 2:Part C: PF-02341066 280 mg/m2/Dose BID | 10 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 38
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 14
- group Id
- OG007
- value
- 10
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 38
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 14
- group Id
- OG007
- value
- 10
- units
- Participants
- description
- The descriptions and grading scales found in the revised NCI CTCAE version 4.0 will be utilized for AE reporting.
- groups
- description
- Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
- id
- OG000
- title
- Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID
- description
- Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
- id
- OG001
- title
- Phase 1: Part A:PF-02341066 130 mg/m²/Dose BID
- description
- Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
- id
- OG002
- title
- Phase 1: Part A:PF-02341066 165 mg/m²/Dose BID
- description
- Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
- id
- OG003
- title
- Phase 1: Part A:PF-02341066 215 mg/m²/Dose BID
- description
- Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
- id
- OG004
- title
- Phase 1: Part A:PF-02341066 280 mg/m²/Dose BID
- description
- Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
- id
- OG005
- title
- Phase 1: Part A: PF-02341066 365 mg/m²/Dose BID
- description
- Part B: Patients with ALK+ relapsed/refractory neuroblastoma
- id
- OG006
- title
- Phase 2: Part B: PF-02341066 280 mg/m2/Dose BID
- description
- Part C: Patients with ALK+ relapsed/refractory ALCL
- id
- OG007
- title
- Phase 2:Part C: PF-02341066 280 mg/m2/Dose BID
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All patients included in analysis
- reporting Status
- POSTED
- time Frame
- Up to 30 days post-treatment
- title
- Number of Participants With Toxicities of Crizotinib
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice