Trial · NCT02508532
(NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors
NCT02508532, Phase 1, Completed, Blueprint Medicines Corporation; results first posted 2021-06-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. (NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors. Trials, record NCT02508532. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02508532
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- (NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors
- NCT number
- NCT02508532
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 250 participants, actual
- Lead sponsor
- Blueprint Medicines Corporation
- Conditions
- Gastrointestinal Stromal Tumors (GIST), Other Relapsed or Refractory Solid Tumors
- Interventions
- Avapritinib
- First posted
- 2015-07-27
- Last updated
- 2022-06-21
- Results first posted
- 2021-06-22
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Avapritinib | Cycle 1 (28 days) of treatment | Patients with event(s) of dose-limiting toxicity |
| Primary | Parts 1 and 2: Number of Patients With Adverse Events (AE) and Serious Adverse Events (SAE) | 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 | 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. |
| Primary | Part 2: Objective Response Rate (ORR) Determined by Central Radiology Assessment Per mRECIST, Version 1.1 | 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. | 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 |
| Secondary | Maximum Plasma Drug Concentration (Cmax) | Cycle 1 Day 1 | Maximum plasma drug concentration (Cmax) following a single dose of avapritinib |
| Secondary | Time to Maximum Plasma Drug Concentration (Tmax) | Cycle 1 Day 1 | Cycle 1 Day 1 PK time to maximum plasma drug concentration (Tmax) |
| Secondary | Plasma Drug Concentration at 24 Hours Postdose Prior to the Next Daily Dose (C24) | Cycle 1 Day 1 | Plasma drug concentration at 24 hours postdose prior to the next daily dose (C24) following a single dose of avapritinib |
| Secondary | Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC 0-24) | Cycle 1 Day 1 | Area under the plasma concentration-time curve from time 0 to 24 hours (AUC 0-24) following a single dose of avapritinib |
| Secondary | Apparent Oral Clearance Unadjusted for Bioavailability (CL/F) | Cycle 1 Day 1 | Apparent oral clearance unadjusted for bioavailability (CL/F) following a single dose of avapritinib |
| Secondary | Apparent Volume of Distribution, Unadjusted for Bioavailability (Vz/F) | Cycle 1 Day 1 | Apparent volume of distribution, unadjusted for bioavailability (Vz/F) following a single dose of avapritinib |
| Secondary | Terminal Elimination Half-life (t1/2) | Cycle 1 Day 1 | Terminal elimination half-life (t1/2) following a single dose of avapritinib |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Avapritinib | Cycle 1 (28 days) of treatment | Patients that completed Part 1 or had a DLT | patients with event(s) of dose-limiting | NUMBER |
| PRIMARY | Parts 1 and 2: Number of Patients With Adverse Events (AE) and Serious Adverse Events (SAE) | 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 | Safety Population - all patients that received at least one dose of avapritinib | participants | NUMBER |
| PRIMARY | Part 2: Objective Response Rate (ORR) Determined by Central Radiology Assessment Per mRECIST, Version 1.1 | 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. | patients enrolled in Part 1 or Part 2 with a starting dose of 300 or 400 mg, including 13 patients enrolled in Part 1 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Plasma Drug Concentration (Cmax) | Cycle 1 Day 1 | Patients enrolled in Part 1 and Part 2 with a starting dose of 300 or 400 mg QD and available samples for PK | ng/mL | MEDIAN |
| SECONDARY | Time to Maximum Plasma Drug Concentration (Tmax) | Cycle 1 Day 1 | Patients enrolled in Part 1 and Part 2 with available samples for PK | hours | MEDIAN |
| SECONDARY | Plasma Drug Concentration at 24 Hours Postdose Prior to the Next Daily Dose (C24) | Cycle 1 Day 1 | Patients enrolled in Part 1 or Part 2 with a starting dose of 300 or 400 mg QD and available PK samples | ng/mL | MEAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC 0-24) | Cycle 1 Day 1 | Patients enrolled in Part 1 or Part 2 with a starting dose of 300 or 400 mg QD and available PK samples | h*ng/mL | MEAN |
| SECONDARY | Apparent Oral Clearance Unadjusted for Bioavailability (CL/F) | Cycle 1 Day 1 | Patients enrolled in Part 1 or Part 2 with a starting dose of 300 or 400 mg QD and available PK samples | L/h | MEAN |
| SECONDARY | Apparent Volume of Distribution, Unadjusted for Bioavailability (Vz/F) | Cycle 1 Day 1 | Patients enrolled in Part 1 and Part 2 with a starting dose of 300 or 400 mg QD and available PK samples | L | MEAN |
| SECONDARY | Terminal Elimination Half-life (t1/2) | Cycle 1 Day 1 | Patients enrolled in Part 1 or Part 2 with a starting dose of 300 or 400 mg QD and available PK samples | h | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group75
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Avapritinib | Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD | 0 | patients with event(s) of dose-limiting | ||
| Part 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Avapritinib | Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD | 0 | patients with event(s) of dose-limiting | ||
| Part 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Avapritinib | Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD | 0 | patients with event(s) of dose-limiting | ||
| Part 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Avapritinib | Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD | 0 | patients with event(s) of dose-limiting | ||
| Part 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Avapritinib | Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD | 0 | patients with event(s) of dose-limiting | ||
| Part 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Avapritinib | Experimental: Part 1 Avapritinib (Formerly BLU-285) 300 mg QD | 0 | patients with event(s) of dose-limiting | ||
| Part 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Avapritinib | Experimental: Part 1 Avapritinib (Formerly BLU-285) 400 mg QD | 0 | patients with event(s) of dose-limiting | ||
| Part 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Avapritinib | Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD | 2 | patients with event(s) of dose-limiting | ||
| Parts 1 and 2: Number of Patients With Adverse Events (AE) and Serious Adverse Events (SAE) | Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD | Participants with an Adverse Event | 6 | participants | |
| Parts 1 and 2: Number of Patients With Adverse Events (AE) and Serious Adverse Events (SAE) | Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD | Participants with an Adverse Event | 6 | participants |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 results by groupParticipant flow90
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 - Dose Determining Period | STARTED | Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD | 6 | |
| Part 1 - Dose Determining Period | STARTED | Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD | 6 | |
| Part 1 - Dose Determining Period | STARTED | Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD | 6 | |
| Part 1 - Dose Determining Period | STARTED | Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD | 6 | |
| Part 1 - Dose Determining Period | STARTED | Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD | 6 | |
| Part 1 - Dose Determining Period | STARTED | Experimental: Part 1 Avapritinib (Formerly BLU-285) 300 mg QD | 6 | |
| Part 1 - Dose Determining Period | STARTED | Experimental: Part 1 Avapritinib (Formerly BLU-285) 400 mg QD | 7 | |
| Part 1 - Dose Determining Period | STARTED | Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD | 3 | |
| Part 1 - Dose Determining Period | STARTED | Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 or 400 mg QD | 0 | |
| Part 1 - Dose Determining Period | Patients From Part 1 Included in the Part 2 Analyses | Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD | 0 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 participant flowAdverse events1,477
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD | 1 | 6 | |
| other | Neutropenia | Blood and lymphatic system disorders | Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD | 1 | 6 | |
| other | Neutropenia | Blood and lymphatic system disorders | Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD | 0 | 6 | |
| other | Neutropenia | Blood and lymphatic system disorders | Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD | 0 | 6 | |
| other | Neutropenia | Blood and lymphatic system disorders | Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD | 1 | 6 | |
| other | Neutropenia | Blood and lymphatic system disorders | Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD | 1 | 3 | |
| other | Neutropenia | Blood and lymphatic system disorders | Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 or 400 mg QD | 24 | 217 | |
| other | Leukopenia | Blood and lymphatic system disorders | Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD | 1 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD | 1 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD | 0 | 6 |
1 to 10 of 1,477Source ClinicalTrials.gov
See all 1,477 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD | 0 | 6 |
| Total, all-cause mortality | Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD | 4 | 6 |
| Total, all-cause mortality | Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD | 2 | 6 |
| Total, all-cause mortality | Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD | 4 | 6 |
| Total, all-cause mortality | Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD | 3 | 6 |
| Total, all-cause mortality | Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD | 1 | 3 |
| Total, all-cause mortality | Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 or 400 mg QD | 111 | 217 |
| Total, other adverse events | Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD | 6 | 6 |
| Total, other adverse events | Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD | 6 | 6 |
| Total, other adverse events | Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD | 5 | 6 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02508532
GET https://conductscience.org/api/trials/v1/NCT02508532/registered?page=2