Trial · NCT02508532
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| 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 |
| Secondary | Maximum Plasma Drug Concentration (Cmax) at Steady State | Cycle 1 Day 15 | Maximum plasma drug concentration (Cmax) at steady state following 15 days of QD dosing |
| Secondary | Time of Maximal Concentration (Tmax) at Steady State | Cycle 1 Day 15 | Time of maximal concentration (Tmax) at steady state following 15 days of QD dosing |
| Secondary | Plasma Drug Concentration at 24 Hours Postdose Prior to the Next Daily Dose at Steady State (C24,ss) | Cycle 1 Day 15 | Plasma Drug Concentration at 24 Hours Postdose Prior to the Next Daily Dose at steady state (C24,ss) following 15 days of QD dosing |
| Secondary | Area Under the Plasma Concentration-time Curve Over the Dosing Interval at Steady Sate (AUC0-τ,ss) (τ=24 h) | Cycle 1 Day 15 | Area under the plasma concentration-time curve over the dosing interval at steady sate (AUC0-τ,ss) (τ=24 h) following 15 days of QD dosing |
| Secondary | Progression-free Survival 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. | Progression-free survival is defined as the time in months from the start of treatment to the date of first documented progression or death due to any cause. Progression-free survival determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST), version 1.1 in patients with advanced GIST. A progressively growing tumor must meet the following criteria: a) the target lesions must be greater or equal to 2cm in size and be a new GIST active lesion or b) the target lesions must be expanding on at least 2 sequential imaging studies. |
| Secondary | Apparent Oral Clearance at Steady State, Unadjusted for Bioavailability (CLss/F) | Cycle 1 Day 15 | Apparent oral clearance at steady state, unadjusted for bioavailability (CLss/F) following 15 days of QD dosing |
| Secondary | Clinical Benefit Rate 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. | Percent of patients with a complete response, partial response or stable disease lasting more than 16 weeks. 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. Stable disease is defined as a tumor that does not meet the criteria for progression or for response. A progressively growing tumor must meet the following criteria: a) the target lesions must be greater or equal to 2cm in size and be a new GIST active lesion or b) the target lesions must be expanding on at least 2 sequential imaging studies. |
| Secondary | Response Rate Determined by Central Radiology Assessment Per Choi Criteria | 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. | A complete response is defined as complete disappearance of all target lesions. A partial response is ≥10% decrease tumor size at computed tomography (CT) or ≥15% decrease in tumor attenuation at computed tomography (CT) and no new lesions. The response rate is defined as complete response plus partial response. |
| Secondary | Duration of Response 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. | Duration from time to first documented CR/PR to date of first documented disease progression or death. 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 | Median PFS on Last Prior Anti-cancer Therapy | Historical data collected at enrollment, all available data on prior therapy was collected | Progression Free Survival (PFS) is defined as the time in months from the start of treatment to the date of first documented disease progression or death due to any cause, which ever occurs first. PFS on last prior anti-cancer therapy is defined as the time in months from the start of last prior anti-cancer therapy to progression on that therapy. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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