NCT02508532 · STUDY IN CONTEXT

(NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Patients with event(s) of dose-limiting toxicity

Patients that completed Part 1 or had a DLT

→

primary · POSTED

The overall safety profile of the drug was assessed by reviewing the number of patients with AEs, SAEs and other events. There was no formal statistical analysis. Safety assessments continued for the duration of treatment.

Safety Population - all patients that received at least one dose of avapritinib

→

primary · POSTED

To evaluate objective response rate (ORR) determined by central radiology assessment per mRECIST, version 1.1 in patients with advanced GIST treated with avapritinib. A complete response per modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) is defined as complete disappearance of all target lesions. A partial response is defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Overall Response (OR) = CR + PR

patients enrolled in Part 1 or Part 2 with a starting dose of 300 or 400 mg, including 13 patients enrolled in Part 1

→

secondary · POSTED

Maximum plasma drug concentration (Cmax) following a single dose of avapritinib

Patients enrolled in Part 1 and Part 2 with a starting dose of 300 or 400 mg QD and available samples for PK

→

secondary · POSTED

Cycle 1 Day 1 PK time to maximum plasma drug concentration (Tmax)

Patients enrolled in Part 1 and Part 2 with available samples for PK

→

secondary · POSTED

Plasma drug concentration at 24 hours postdose prior to the next daily dose (C24) following a single dose of avapritinib

Patients enrolled in Part 1 or Part 2 with a starting dose of 300 or 400 mg QD and available PK samples

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-gastrointestinal-stromal-tumors
nct id: NCT02508532
trial label: (NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 7
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0000
source section id
NCT02508532-om-0000
source outcome index
0
endpoint
Part 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Avapritinib
endpoint definition
Patients with event(s) of dose-limiting toxicity
time origin
Cycle 1 (28 days) of treatment
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients that completed Part 1 or had a DLT
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0001
source section id
NCT02508532-om-0001
source outcome index
1
endpoint
Parts 1 and 2: Number of Patients With Adverse Events (AE) and Serious Adverse Events (SAE)
endpoint definition
The overall safety profile of the drug was assessed by reviewing the number of patients with AEs, SAEs and other events. There was no formal statistical analysis. Safety assessments continued for the duration of treatment.
time origin
AEs were collected from the start of study drug until 30 days after the last dose, SAEs were collected from the date of the informed consent signature until 30 days after the last dose of study drug, up to 5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Safety Population - all patients that received at least one dose of avapritinib
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0002
source section id
NCT02508532-om-0002
source outcome index
2
endpoint
Part 2: Objective Response Rate (ORR) Determined by Central Radiology Assessment Per mRECIST, Version 1.1
endpoint definition
To evaluate objective response rate (ORR) determined by central radiology assessment per mRECIST, version 1.1 in patients with advanced GIST treated with avapritinib. A complete response per modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) is defined as complete disappearance of all target lesions. A partial response is defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Overall Response (OR) = CR + PR
time origin
Tumor assessments were performed at screening, Cycle 3 Day 1, then every 2 cycles through Cycle 13, then every 3 cycles thereafter up to approximately 4 years. Each cycle is 28 days.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
patients enrolled in Part 1 or Part 2 with a starting dose of 300 or 400 mg, including 13 patients enrolled in Part 1
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0003
source section id
NCT02508532-om-0003
source outcome index
3
endpoint
Maximum Plasma Drug Concentration (Cmax)
endpoint definition
Maximum plasma drug concentration (Cmax) following a single dose of avapritinib
time origin
Cycle 1 Day 1
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients enrolled in Part 1 and Part 2 with a starting dose of 300 or 400 mg QD and available samples for PK
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0004
source section id
NCT02508532-om-0004
source outcome index
4
endpoint
Time to Maximum Plasma Drug Concentration (Tmax)
endpoint definition
Cycle 1 Day 1 PK time to maximum plasma drug concentration (Tmax)
time origin
Cycle 1 Day 1
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients enrolled in Part 1 and Part 2 with available samples for PK
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0005
source section id
NCT02508532-om-0005
source outcome index
5
endpoint
Plasma Drug Concentration at 24 Hours Postdose Prior to the Next Daily Dose (C24)
endpoint definition
Plasma drug concentration at 24 hours postdose prior to the next daily dose (C24) following a single dose of avapritinib
time origin
Cycle 1 Day 1
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients enrolled in Part 1 or Part 2 with a starting dose of 300 or 400 mg QD and available PK samples
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0000
arm key
OG000
arm label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD
regimen
Part 1: Patients received a starting dose of 30 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02508532-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0000
arm key
OG001
arm label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD
regimen
Part 1: Patients received a starting dose of 60 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02508532-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0000
arm key
OG002
arm label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD
regimen
Part 1: Patients received a starting dose of 90 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02508532-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0000
arm key
OG003
arm label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD
regimen
Part 1: Patients received a starting dose of 135 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02508532-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0000
arm key
OG004
arm label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD
regimen
Part 1: Patients received a starting dose of 200 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. .
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02508532-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0000
arm key
OG005
arm label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 300 mg QD
regimen
Part 1: Patients received a starting dose of 300 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. Patients that received at least one dose of avapritinib were included in the Part 2 analysis.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02508532-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0000
arm key
OG006
arm label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 400 mg QD
regimen
Part 1: Patients received a starting dose of 400 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. Patients that received at least one dose of avapritinib were included in the Part 2 analysis.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02508532-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0000
arm key
OG007
arm label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD
regimen
Part 1: Patients received a starting dose of 600 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02508532-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0001
arm key
OG000
arm label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD
regimen
Part 1: Patients received a starting dose of 30 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02508532-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0001
arm key
OG001
arm label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD
regimen
Part 1: Patients received a starting dose of 60 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02508532-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0001
arm key
OG002
arm label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD
regimen
Part 1: Patients received a starting dose of 90 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02508532-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
outcome key
om-0001
arm key
OG003
arm label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD
regimen
Part 1: Patients received a starting dose of 135 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02508532-om-0001#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
harm key
EG000
source section id
NCT02508532-ae
event group key
EG000
event group label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD
serious affected
3
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
For each patient adverse event data were collected starting at the time of the first dose of study drug until 30 days after the final dose of study drug. Serious adverse event data were collected from the time the informed consent was signed until 30 days after the final dose of study drug. On average 8 months, up to 5 years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
harm key
EG001
source section id
NCT02508532-ae
event group key
EG001
event group label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD
serious affected
4
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
For each patient adverse event data were collected starting at the time of the first dose of study drug until 30 days after the final dose of study drug. Serious adverse event data were collected from the time the informed consent was signed until 30 days after the final dose of study drug. On average 8 months, up to 5 years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
harm key
EG002
source section id
NCT02508532-ae
event group key
EG002
event group label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD
serious affected
5
serious at risk
6
other affected
5
other at risk
6
frequency threshold
5
collection period
For each patient adverse event data were collected starting at the time of the first dose of study drug until 30 days after the final dose of study drug. Serious adverse event data were collected from the time the informed consent was signed until 30 days after the final dose of study drug. On average 8 months, up to 5 years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
harm key
EG003
source section id
NCT02508532-ae
event group key
EG003
event group label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD
serious affected
5
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
For each patient adverse event data were collected starting at the time of the first dose of study drug until 30 days after the final dose of study drug. Serious adverse event data were collected from the time the informed consent was signed until 30 days after the final dose of study drug. On average 8 months, up to 5 years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
harm key
EG004
source section id
NCT02508532-ae
event group key
EG004
event group label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD
serious affected
5
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
For each patient adverse event data were collected starting at the time of the first dose of study drug until 30 days after the final dose of study drug. Serious adverse event data were collected from the time the informed consent was signed until 30 days after the final dose of study drug. On average 8 months, up to 5 years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
harm key
EG005
source section id
NCT02508532-ae
event group key
EG005
event group label
Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD
serious affected
3
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
For each patient adverse event data were collected starting at the time of the first dose of study drug until 30 days after the final dose of study drug. Serious adverse event data were collected from the time the informed consent was signed until 30 days after the final dose of study drug. On average 8 months, up to 5 years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT02508532
harm key
EG006
source section id
NCT02508532-ae
event group key
EG006
event group label
Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 or 400 mg QD
serious affected
140
serious at risk
217
other affected
214
other at risk
217
frequency threshold
5
collection period
For each patient adverse event data were collected starting at the time of the first dose of study drug until 30 days after the final dose of study drug. Serious adverse event data were collected from the time the informed consent was signed until 30 days after the final dose of study drug. On average 8 months, up to 5 years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice