Trial · NCT00697346
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 41
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-Limiting Toxicity (DLT) | From first dose of study drug to 30 days after the last dose (up to 422 days) | DLT was evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and was defined as any of the following events related to therapy with alisertib:1. Grade 4 neutropenia lasting ≥7 consecutive days, 2. Grade 4 neutropenia with fever and/or infection 3. Platelet count \<25,000/mm\^3 4. Grade 3 or greater nausea and/or emesis despite use of optimal antiemetic prophylaxis 5. Grade 3 or greater diarrhea despite maximal supportive therapy with loperamide 6. Any other Grade 3 or greater nonhematologic toxicity, with the following exceptions: Grade 3 arthralgia/myalgias, Any grade of alopecia, Brief (\<1 week) Grade 3 fatigue 7. Treatment delay of \>21 days due to failure of adequate hematologic or non-hematologic recovery from previous cycle of treatment 8. Other alisertib related non-hematologic toxicities ≥Grade 2 that, in the opinion of the investigator required a dose reduction or discontinuation of therapy with alisertib. |
| Primary | Maximum Tolerated Dose (MTD) of Alisertib | From first dose of study drug to 30 days after the last dose (up to 422 days) | MTD was defined as the highest dose at which DLT occurred in 0/3 or 1/6 participants. |
| Primary | Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 1 | Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose | |
| Primary | Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose | |
| Primary | Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 1 | Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose | |
| Primary | Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose | |
| Primary | AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose | |
| Primary | Terminal Half-Life (t1/2) for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose | |
| Primary | Accumulation Ratio (Rac) for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose | |
| Primary | Peak/Trough Ratio for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose | |
| Primary | CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21 | Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose | |
| Primary | Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 1 | Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose | |
| Primary | Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | |
| Primary | Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 1 | Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose | |
| Primary | Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | |
| Primary | AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | |
| Primary | Accumulation Ratio (Rac) for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | |
| Primary | Peak/Trough Ratio for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | |
| Primary | CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14 | Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose | |
| Primary | Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 1 | Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose |
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/NCT00697346/registered