Trial · NCT02255461
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Palbociclib in Stratum I | 4 weeks | Patients who were enrolled on stratum I and were evaluable for dose finding assessment were used to determine the MTD for stratum I. | mg/m2/day | NUMBER |
| PRIMARY | Maximum Tolerated Dose (MTD) of Palbociclib in Stratum II | 4 weeks | Patients who were enrolled on stratum II and were evaluable for dose finding assessment were used to determine the MTD for stratum II. | mg/m2/day | NUMBER |
| PRIMARY | Number of Patients Who Experienced Dose Limiting Toxicities (DLTs) | 4 weeks | Patients who received at least one dose of palbociclib were included in the analysis. One patient in stratum II dose level 2 who withdrew prior to beginning protocol therapy was excluded. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Single Dose Apparent Volume of Central Compartment (Vc/F) | Up to day 3 | Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included. | L/m^2 | MEDIAN |
| PRIMARY | Single Dose Elimination Rate Constant (Ke) | Up to day 3 | Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included. | per hour | MEDIAN |
| PRIMARY | Single Dose Half-life (t1/2) | Up to day 3 | Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included. | hour | MEDIAN |
| PRIMARY | Single Dose Apparent Oral Clearance (CL/F) | Up to day 3 | Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included. | L/h/m^2 | MEDIAN |
| PRIMARY | Single Dose Area Under the Plasma Concentration Time Curve (AUC) | Up to day 3 | Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included. | h*ng/mL | MEDIAN |
| PRIMARY | Steady State Apparent Volume of Central Compartment (Vc/F) | Up to day 22 | Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included. | L/m^2 | MEDIAN |
| PRIMARY | Steady State Elimination Rate Constant (Ke) | Up to day 22 | Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included. | per hour | MEDIAN |
| PRIMARY | Steady State Half-life (t1/2) | Up to day 22 | Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included. | hour | MEDIAN |
| PRIMARY | Steady State Apparent Oral Clearance (CL/F) | Up to day 22 | Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included. | L/h/m^2 | MEDIAN |
| PRIMARY | Steady State Area Under the Plasma Concentration Time Curve (AUC) | Up to day 22 | Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included. | h*ng/mL | MEDIAN |
| SECONDARY | Number of Subjects With Objective Responses | Up to 2 years | Patients who received at least one dose of palbociclib were included in the analysis. One patient in stratum II dose level 2 who withdrew prior to beginning protocol therapy was excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Association Between Neutropenia and Single Dose Palbociclib AUC | Up to approximately 4 weeks | It was pre-specified that data from all participants from different dose levels and strata were combined to calculate an association between neutropenia and single dose AUC for all participants. Of 35 patients enrolled, one patient in stratum II withdrew prior to protocol therapy and was excluded. | h*ng/mL | MEAN |
| SECONDARY | Association Between Lymphopenia and Single Dose Palbociclib AUC | Up to approximately 4 weeks | It was pre-specified that data from all participants from different dose levels and strata were combined to calculate an association between lymphopenia and single dose AUC for all participants. Of 35 patients enrolled, one patient in stratum II withdrew prior to protocol therapy and was excluded. | h*ng/mL | MEAN |
| SECONDARY | Association Between Leukopenia and Single Dose Palbociclib AUC | Up to approximately 4 weeks | It was pre-specified that data from all participants from different dose levels and strata were combined to calculate an association between leukopenia and single dose AUC for all participants. Of 35 patients enrolled, one patient in stratum II withdrew prior to protocol therapy and was excluded. | h*ng/mL | MEAN |
| OTHER_PRE_SPECIFIED | Number of Subjects With Cyclin-dependent Kinase-4 (CDK4) Copy Number Variations | At enrollment | |||
| OTHER_PRE_SPECIFIED | Number of Subjects With Cyclin-dependent Kinase-6 (CDK6) Copy Number Variations | At enrollment | |||
| OTHER_PRE_SPECIFIED | Number of Subjects With Cyclin D1 Copy Number Variations | At enrollment |
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/NCT02255461/outcomes