Trial · NCT01708161
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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 |
| Secondary | Tmax and T Half of AMG - Phase Ib | Cycle 1 Day 15 | Tmax and half life of AMG 479 (ganitumab) 1 cycle - 28 days of treatment |
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.
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GET https://conductscience.org/api/trials/v1/NCT01708161/registered