Trial · NCT02273219
Trial of AEB071 in Combination With BYL719 in Patients With Melanoma
NCT02273219, Phase 1, Completed, Columbia University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of AEB071 in Combination With BYL719 in Patients With Melanoma. Trials, record NCT02273219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02273219
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of AEB071 in Combination With BYL719 in Patients With Melanoma
- NCT number
- NCT02273219
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 30 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Uveal Melanoma
- Interventions
- AEB071, BYL719
- First posted
- 2014-10-23
- Last updated
- 2023-08-15
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total maximum tolerated dose (in milligrams) of AEB071 in combination with BYL719 | 4 years (approximately) | Establish the maximum tolerated dose (up to 400 mg twice daily) for AEB071 and up to 350 mg daily for BYL719 |
| Secondary | Number of participants with adverse events | 4 years (approximately) | Obtain safety data of the combination therapy of AEB071 with BYL719 |
| Secondary | Change in area under the curve (AUC) for the combination of AEB071 and BYL719 | Cycle 1 Day 1, pre-dose, .5, 1, 2, 4, 6, 8, and 24 hours post dose, Cycle 1, Day 8, pre-dose, .5, 1, 2, 4, 6, and 8 hours post dose, Cycle 1 Day 15, pre-dose, Cycle 2-3-4-5-6 Day 1, pre-dose | To evaluate the pharmacokinetic properties of the combination of AEB071 and BYL719 at varying dose levels utilizing standard pharmacokinetic parameters such as peak concentration (Cmax) and area under the curve (AUC) of AEB071 and BYL719 in plasma samples. |
| Secondary | Change in peak concentration (Cmax) for the combination of AEB071 and BYL719 | Cycle 1 Day 1, pre-dose, .5, 1, 2, 4, 6, 8, and 24 hours post dose, Cycle 1, Day 8, pre-dose, .5, 1, 2, 4, 6, and 8 hours post dose, Cycle 1 Day 15, pre-dose, Cycle 2-3-4-5-6 Day 1, pre-dose | To evaluate the pharmacokinetic properties of the combination of AEB071 and BYL719 at varying dose levels utilizing standard pharmacokinetic parameters such as peak concentration (Cmax) and area under the curve (AUC) of AEB071 and BYL719 in plasma samples. |
| Secondary | Number participants who respond to therapy | 4 years (approximately) | Clinical benefit rate will be assessed as overall object response rate, using metric measurements on imaging scans. |
| Secondary | Change in numerically calculated toxicity burden (0-10) | baseline, Cycle 1 Day 8, Day 15, and Day 22, Cycle 2 and above, End of Treatment, 28 day Follow-Up visit | To explore the toxicity burden on the patient during treatment as perceived by the patient and the physician. |
| Secondary | Mean months of overall survival | 4 years (approximately) | Overall survival will be calculated in months, starting at time of enrollment. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02273219
GET https://conductscience.org/api/trials/v1/NCT02273219/registered