Trial · NCT04589650
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants Randomized to Alpelisib With a Confirmed Objective Response by BIRC in Group 1 and Group 2 | Up to 48 weeks | Full Analysis Set (FAS) - BYL719. All patients to whom alpelisib had been assigned by randomization. | % of confirmed responder by BIRC | NUMBER |
| SECONDARY | Key Secondary Objective: Proportion of Participants With Response at Week 16 by BIRC in Group 1 and Group 2 | Week 16 | Full Analysis Set (FAS). All patients to whom study treatment was assigned by randomization. | % of responder by BIRC | NUMBER |
| SECONDARY | Proportion of Participants With a Response at Week 24 (by BIRC) in Groups 1 and 2 | Week 24 | Full Analysis Set (FAS) - BYL719. All patients to whom alpelisib had been assigned by randomization. | % of confirmed responder by BIRC | NUMBER |
| SECONDARY | Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 | Up to Week 16 | Safety Set. All patients who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency and Severity of Adverse Events in All Groups of Participants Over Time | Up to approximately 5 years | |||
| SECONDARY | Change From Baseline to Week 16 in Brief Pain Inventory (BPI) Worst Pain Intensity in Group 1 and 2 | Baseline, Week 4, Week 8, Week 12, Week 16 | Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included. | Score on a scale | MEAN |
| SECONDARY | Number of Participants With Global Impression of Symptom Severity (PGIS) Score up to Week 16 | Week 4, Week 8, Week 16 | Full Analysis Set (FAS). Only participants with an available value for the outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage Change From Baseline in Target and MRI-measurable Non- Target Lesion Volume in Group 1 and Group 2 | From Baseline up to approximately 5 years | |||
| SECONDARY | Proportion of Participants With Changes From Baseline in Other Non-target Lesions in Group 1 and Group 2 | From Baseline up to approximately 5 years | |||
| SECONDARY | Proportion of Participants With New Lesions in Group 1 and Group 2 | From Baseline up to approximately 5 years | |||
| SECONDARY | Pharmacokinetics (PK) of Alpelisib in Group 1 and Group 2: Maximum Concentration (Cmax) | Week 17 Day 1 (Pre-dose, 1h post dose, 3h post dose, 5h post dose, 8h post dose , 24h post dose/ Pre-dose of Day 2), Week 20 Day 1 (Pre-dose, 3h post dose) and after Week 28, on Day 1 (Pre-dose and 3h post dose) 4 weeks after the first dose escalation | |||
| SECONDARY | Pharmacokinetics (PK) of Alpelisib in Group 1 and Group 2: Trough Concentration (Ctrough) | Week 17 Day 1 (Pre-dose and 24 h post dose/ Pre-dose of Day 2), Week 20 Day 1 (Pre-dose) and after Week 28, on Day 1 (Pre-dose) 4 weeks after the first dose escalation | |||
| SECONDARY | Change From Baseline in Patient-reported Pain Assessed by Brief Pain Inventory (BPI) Worst Pain Intensity Item or Wong-Baker Faces Scale (Age Appropriate) in Pediatric and Adult Populations | From Baseline up to approximately 5 years | |||
| SECONDARY | Changes From Baseline in Patient-reported Health-related Quality of Life Assessed by PROMIS-profile (Patient Reported Outcome Measurement Information System) in Pediatric and Adult Populations | From Baseline up to approximately 5 years | |||
| SECONDARY | Changes From Baseline in Patient-reported Overall Impression of Symptoms Assessed by Patient Global Impression of Symptom Severity (PGIS) in Pediatric and Adult Populations | From Baseline up to approximately 5 years | |||
| SECONDARY | Duration of Response (DOR) in Participants Who Received Alpelisib in Group 1 and Group 2 | From first documented response until progression of PROS lesions or death, assessed up to approximately 5 years | |||
| SECONDARY | Time to Treatment Failure in Participants Who Received Alpelisib in Group 1 and Group 2 | From Baseline up to approximately 5 years | |||
| SECONDARY | Overall Clinical Response Rate as Assessed by Investigator in Participants Who Received Alpelisib in Group 1 and Group 2 | Week 16, 24, 40, 48, 72, 96 and thereafter every 48 weeks | |||
| SECONDARY | Proportion of Participants With Response During the Extension Period in Group 1 and Group 2 | Week 40, 48, 72, 96, 144, 192, 240 and 264. | |||
| SECONDARY | Changes in Symptoms and Complications/Comorbidities up to Week 16 on Treatment With Alpelisib as Compared to Placebo in Group 1 and Group 2 | Baseline up to Week 16 |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04589650/outcomes