NCT04579757 · OUTCOME
Dose Expansion Phase: Number of Patients With Treatment-Emergent Adverse Events, Treatment-Emergent Serious Adverse Events and TEAEs Leading to Treatment Discontinuation
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
- From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 33 months
What was measured
An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment in humans, whether or not considered related to the treatment. An AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that started or worsened in severity on or after the first dose of study treatment and up to 30 days after the date of last study treatment administration.
Analysis population: The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
Groups in this outcome
Dose Expansion Phase: Cohort A: CRC
Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Dose Expansion Phase: Cohort B1: Thoracic NETs
Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Dose Expansion Phase: Cohort B2: GEP NETs
Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Dose Expansion Phase: Cohort C: SCLC
Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Dose Expansion Phase: Cohort D: GC
Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Dose Expansion Phase: Cohort E2: UPS
Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Dose Expansion Phase: Cohort F: ATC
Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
| Group | Source count |
|---|---|
| Dose Expansion Phase: Cohort A: CRC | 15 |
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 10 |
| Dose Expansion Phase: Cohort B2: GEP NETs | 20 |
| Dose Expansion Phase: Cohort C: SCLC | 15 |
| Dose Expansion Phase: Cohort D: GC | 3 |
| Dose Expansion Phase: Cohort E2: UPS | 9 |
| Dose Expansion Phase: Cohort F: ATC | 3 |
Reported measurements
Any TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Expansion Phase: Cohort A: CRC | 14 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 10 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort B2: GEP NETs | 20 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort C: SCLC | 15 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort D: GC | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort E2: UPS | 9 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort F: ATC | 3 | Not reported | Not reported | Not reported | Not reported |
Any TESAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Expansion Phase: Cohort A: CRC | 9 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort B2: GEP NETs | 9 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort C: SCLC | 8 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort D: GC | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort E2: UPS | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort F: ATC | 1 | Not reported | Not reported | Not reported | Not reported |
Any TEAEs leading to surufatinib treatment discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Expansion Phase: Cohort A: CRC | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort B2: GEP NETs | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort C: SCLC | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort D: GC | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort E2: UPS | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort F: ATC | 0 | Not reported | Not reported | Not reported | Not reported |
Any TEAEs leading to tislelizumab treatment discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Expansion Phase: Cohort A: CRC | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort B2: GEP NETs | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort C: SCLC | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort D: GC | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort E2: UPS | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort F: ATC | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 3
- title
- Any TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 1
- title
- Any TESAEs
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- title
- Any TEAEs leading to surufatinib treatment discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- title
- Any TEAEs leading to tislelizumab treatment discontinuation
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 3
- units
- Participants
- description
- An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment in humans, whether or not considered related to the treatment. An AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that started or worsened in severity on or after the first dose of study treatment and up to 30 days after the date of last study treatment administration.
- groups
- description
- Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- id
- OG000
- title
- Dose Expansion Phase: Cohort A: CRC
- description
- Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- id
- OG001
- title
- Dose Expansion Phase: Cohort B1: Thoracic NETs
- description
- Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- id
- OG002
- title
- Dose Expansion Phase: Cohort B2: GEP NETs
- description
- Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- id
- OG003
- title
- Dose Expansion Phase: Cohort C: SCLC
- description
- Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- id
- OG004
- title
- Dose Expansion Phase: Cohort D: GC
- description
- Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- id
- OG005
- title
- Dose Expansion Phase: Cohort E2: UPS
- description
- Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- id
- OG006
- title
- Dose Expansion Phase: Cohort F: ATC
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
- reporting Status
- POSTED
- time Frame
- From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 33 months
- title
- Dose Expansion Phase: Number of Patients With Treatment-Emergent Adverse Events, Treatment-Emergent Serious Adverse Events and TEAEs Leading to Treatment Discontinuation
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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