Trial · NCT01708161
A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors
NCT01708161, Phase 1, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2018-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors. Trials, record NCT01708161. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01708161
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors
- NCT number
- NCT01708161
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- PIK3CA Mutated Advanced Solid Tumors, PIK3CA Amplified Advanced Solid Tumors
- Interventions
- BYL719, AMG 479
- First posted
- 2012-10-16
- Last updated
- 2018-09-13
- Other registries' IDs
- eudract:2012-001962-13
- Results first posted
- 2018-06-28
- Limitations and caveats
Due to the competitive landscape for anticancer therapies in ovarian and breast cancer and given the limited clinical activity observed with the study combination treatment, Novartis decided in 2014 to halt the recruitment in the trial.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Limiting Toxicities (DLTs) - Phase Ib | 28 days | Phase lb only |
| Primary | Percentage of Patients With Overall Response Rate (RECIST) Based on Investigator Radiology Assessment for HR Positive Breast and Ovarian Cancer - Phase II | Approximately 1 year (since initiation of Phase II, Dec 2013, till Primary CSR cut off 06Jan2015) | The antitumor activity of alpelisib in combination with ganitumab in patients with PIK3CA mutated or amplified hormone receptor positive (HR+) breast (arm 1) or ovarian (arm 2) cancer. Overall response rate is defined as the proportion of patients who have a best overall response of complete response or partial response assessed per RECIST 1.1. |
| Secondary | Number of Patients With Best Overall Response (RECIST) Based on Investigator Radiology Assessment - Phase Ib | Approximately 1 year (since FPFV 27Nov2012, till MTD declaration 26Nov2013) | The anti-tumor activity of alpelisib and ganitumab in combination as per RECIST 1.1 |
| Secondary | Percentage of Patients With Disease Control Rate (RECIST) Based on Investigator Radiology Assessment - Phase Ib | Approximately 1 year (since FPFV 27Nov2012, till MTD declaration 26Nov2013) | The anti-tumor activity of alpelisib and ganitumab in combination as per RECIST 1.1 |
| Secondary | Percentage of Patients With Disease Control Rate (RECIST) Based on Investigator Radiology Assessment for HR Positive Breast and Ovarian Cancer - Phase II | Approximately 1 year (since initiation of Phase II, Dec 2013, till Primary CSR cut off 06Jan2015) | the antitumor activity of alpelisib in combination with ganitumab in patients with PIK3CA mutated or amplified hormone receptor positive (HR+) breast (arm 1) or ovarian (arm 2) cancer. Phase II only, Cycle 1 Day 1 through Cycle 6 Day 28; assessed at baseline and every 8 weeks thereafter |
| Secondary | Cmax of BYL - Phase Ib | Cycle 1 Day 1, Cycle 1 Day 15 | Serum concentration for BYL719 (alpelisib) 1 cycle - 28 days of treatment |
| Secondary | Area Under Curve (AUC) 0-24 Hour of BYL - Phase Ib | Cycle 1 Day 1 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 1 Day 15 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose) | Area under curve for BYL719 (alpelisib) 1 cycle - 28 days of treatment |
| Secondary | Tmax and T Half of BYL - Phase Ib | Cycle 1 Day 1, Cycle 1 Day 15 | Tmax and half life of BYL719 (Alpelisib) 1 cycle - 28 days of treatment |
| Secondary | Cmax of AMG - Phase Ib | Cycle 1 Day 15 | Serum concentration for AMG 479 (ganitumab) 1 cycle - 28 days of treatment |
| Secondary | Area Under Curve (AUC) 0-336 Hour of AMG - Phase Ib | Cycle 1 Day 15 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose) | Area under curve for AMG 479 (ganitumab) 1 cycle - 28 days of treatment |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose Limiting Toxicities (DLTs) - Phase Ib | 28 days | Dose determining set (DDS): DDS includes all patients from the safety set who either met the minimum treatment exposure and safety evaluation requirements without experiencing DLT within Cycle 1 or experienced a DLT at any time during Cycle 1. | Participants | NUMBER |
| PRIMARY | Percentage of Patients With Overall Response Rate (RECIST) Based on Investigator Radiology Assessment for HR Positive Breast and Ovarian Cancer - Phase II | Approximately 1 year (since initiation of Phase II, Dec 2013, till Primary CSR cut off 06Jan2015) | Full analysis set (FAS). The full analysis set (FAS) includes all patients who received at least one full or partial dose of alpelisib or ganitumab. Patients were analyzed according to the planned treatment combination. | Percentages of participants | NUMBER |
| SECONDARY | Number of Patients With Best Overall Response (RECIST) Based on Investigator Radiology Assessment - Phase Ib | Approximately 1 year (since FPFV 27Nov2012, till MTD declaration 26Nov2013) | Full Analysis set | Participants | NUMBER |
| SECONDARY | Percentage of Patients With Disease Control Rate (RECIST) Based on Investigator Radiology Assessment - Phase Ib | Approximately 1 year (since FPFV 27Nov2012, till MTD declaration 26Nov2013) | Full Analysis set | Percentages of participants | NUMBER |
| SECONDARY | Percentage of Patients With Disease Control Rate (RECIST) Based on Investigator Radiology Assessment for HR Positive Breast and Ovarian Cancer - Phase II | Approximately 1 year (since initiation of Phase II, Dec 2013, till Primary CSR cut off 06Jan2015) | Full analysis set | Percentages of participants | NUMBER |
| SECONDARY | Cmax of BYL - Phase Ib | Cycle 1 Day 1, Cycle 1 Day 15 | Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received. | ng/mL | MEAN |
| SECONDARY | Area Under Curve (AUC) 0-24 Hour of BYL - Phase Ib | Cycle 1 Day 1 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 1 Day 15 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose) | Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received. | hr*ng/mL | MEAN |
| SECONDARY | Tmax and T Half of BYL - Phase Ib | Cycle 1 Day 1, Cycle 1 Day 15 | Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received. | hr | MEDIAN |
| SECONDARY | Cmax of AMG - Phase Ib | Cycle 1 Day 15 | Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received. | ng/mL | MEAN |
| SECONDARY | Area Under Curve (AUC) 0-336 Hour of AMG - Phase Ib | Cycle 1 Day 15 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose) | Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received. | hr*ng/mL | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose Limiting Toxicities (DLTs) - Phase Ib | BYL 200mg + AMG 12mg/kg | Drug hypersensitivity | 0 | Participants | |
| Dose Limiting Toxicities (DLTs) - Phase Ib | BYL 300mg + AMG 12mg/kg | Drug hypersensitivity | 0 | Participants | |
| Dose Limiting Toxicities (DLTs) - Phase Ib | BYL 350mg + AMG 12mg/kg | Drug hypersensitivity | 1 | Participants | |
| Dose Limiting Toxicities (DLTs) - Phase Ib | BYL 200mg + AMG 12mg/kg | Hyperglycemia | 0 | Participants | |
| Dose Limiting Toxicities (DLTs) - Phase Ib | BYL 300mg + AMG 12mg/kg | Hyperglycemia | 0 | Participants | |
| Dose Limiting Toxicities (DLTs) - Phase Ib | BYL 350mg + AMG 12mg/kg | Hyperglycemia | 1 | Participants | |
| Dose Limiting Toxicities (DLTs) - Phase Ib | BYL 200mg + AMG 12mg/kg | Rash maculopapular | 0 | Participants | |
| Dose Limiting Toxicities (DLTs) - Phase Ib | BYL 300mg + AMG 12mg/kg | Rash maculopapular | 1 | Participants | |
| Dose Limiting Toxicities (DLTs) - Phase Ib | BYL 350mg + AMG 12mg/kg | Rash maculopapular | 0 | Participants | |
| Dose Limiting Toxicities (DLTs) - Phase Ib | BYL 200mg + AMG 12mg/kg | Urticaria | 0 | Participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BYL 200mg + AMG 12mg/kg | 4 | |
| Overall Study | STARTED | BYL 300mg + AMG 12mg/kg | 10 | |
| Overall Study | STARTED | BYL 350mg + AMG 12mg/kg | 10 | |
| Overall Study | STARTED | HR+BC - Phase II | 16 | |
| Overall Study | STARTED | Ovarian - Phase II | 6 | |
| Overall Study | STARTED | Non-HR+BC/Ovarian - Phase II | 1 | |
| Overall Study | COMPLETED | BYL 200mg + AMG 12mg/kg | 0 | |
| Overall Study | COMPLETED | BYL 300mg + AMG 12mg/kg | 0 | |
| Overall Study | COMPLETED | BYL 350mg + AMG 12mg/kg | 0 | |
| Overall Study | COMPLETED | HR+BC - Phase II | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,315
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 | Anaemia | Blood and lymphatic system disorders | BYL 200mg + AMG 12 mg/kg | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | BYL 300mg + AMG 12 mg/kg | 2 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | BYL 350mg + AMG 12 mg/kg | 0 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | HR + BC - Phase II | 2 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | Ovarian - Phase II | 3 | 6 | |
| other | Leukocytosis | Blood and lymphatic system disorders | BYL 200mg + AMG 12 mg/kg | 0 | 4 | |
| other | Leukocytosis | Blood and lymphatic system disorders | BYL 300mg + AMG 12 mg/kg | 1 | 10 | |
| other | Leukocytosis | Blood and lymphatic system disorders | BYL 350mg + AMG 12 mg/kg | 0 | 10 | |
| other | Leukocytosis | Blood and lymphatic system disorders | HR + BC - Phase II | 1 | 16 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Ovarian - Phase II | 0 | 6 |
1 to 10 of 1,315Source ClinicalTrials.gov
See all 1,315 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BYL 200mg + AMG 12 mg/kg | 4 | 4 |
| Total, all-cause mortality | BYL 300mg + AMG 12 mg/kg | 8 | 10 |
| Total, all-cause mortality | BYL 350mg + AMG 12 mg/kg | 8 | 10 |
| Total, all-cause mortality | HR + BC - Phase II | 13 | 16 |
| Total, all-cause mortality | Ovarian - Phase II | 5 | 6 |
| Total, other adverse events | BYL 200mg + AMG 12 mg/kg | 4 | 4 |
| Total, other adverse events | BYL 300mg + AMG 12 mg/kg | 10 | 10 |
| Total, other adverse events | BYL 350mg + AMG 12 mg/kg | 10 | 10 |
| Total, other adverse events | HR + BC - Phase II | 16 | 16 |
| Total, other adverse events | Ovarian - Phase II | 6 | 6 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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/NCT01708161
GET https://conductscience.org/api/trials/v1/NCT01708161/results?page=2