Trial · NCT03792256
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of Dose Limiting Toxicities of Palbociclib | Up to 32 days | The frequency (%) of patients experiencing a cycle 1 dose limiting toxicity at least possibly attributable to Palbociclib by study part and dose level. |
| Primary | Frequency of Adverse Events of Palbociclib | Up to 26 months | The frequency (%) of patients experiencing adverse events at least possibly attributable to Palbociclib by study part and dose level. |
| Primary | Area Under the Drug Concentration Curve of Palbociclib | Up to 11 days | The median (min, max) of the area under the drug concentration curve for Palbociclib determined by measures at 0, 1, 2, 4, 8, and 24 hours post-dose on day 11 by study part and dose level. |
| Primary | Half-life of Palbociclib | Up to 11 days | The median (min, max) of the half-life of Palbociclib determined by measures at 0, 1, 2, 4, 8, and 24 hours post-dose on day 11 by study part and dose level. |
| Primary | Maximum Serum Concentration of Palbociclib | Up to 11 days | Median (min, max) of the maximum serum concentration of Palbociclib determined by measures at 0, 1, 2, 4, 8, and 24 hours post-dose on day 11 by study part and dose level |
| Primary | Time to Reach Maximum Serum Concentration of Palbociclib | Up to 11 days | Median (min, max) of the maximum time to reach serum concentration of Palbociclib determined by measures at 0, 1, 2, 4, 8, and 24 hours post-dose on day 11 by study part and dose level |
| Primary | Clearance of Palbociclib | Up to 11 days | Median (min, max) of the clearance of Palbociclib determined by measures at 0, 1, 2, 4, 8, and 24 hours post-dose on day 11 by study part and dose level |
| Secondary | Number of Participants With at Least Partial Response to Palbociclib | up to 26 months | Frequency (%) of patients with at least partial response to Palbociclib per leukemia/lymphoma specific response criteria: Complete Response (CR), M1 marrow (\<5% blasts) and absolute neutrophil count (ANC) at least 500/uL and platelet count at least 50000/uL without transfusion for 7 days; Complete response with incomplete recovery (CRi), M1 marrow (\<5% blasts), ANC\<500uL, platelet count \<50,000uL; Partial Response (PR), Complete disappearance of circulating blasts and achievement of M2 marrow status if M3 originally, without new sites of extramedullary disease, and with ANC ≥ 500/µL. Complete response in the marrow without resolution of extramedullary sites. Overall Response (OR) = CR+CRi+PR |
| Secondary | Absolute Peripheral Blast Count of Palbociclib | Up to 3 days | Median (min, max) of absolute peripheral blast count of palbociclib by study part and dose level |
| Secondary | Radiographic Response of Palbociclib in Patients With LL Patients | Day 32 | Number of LL patients with radiographic response by study part and dose level. Complete Response (CR): Disappearance of all disease; Partial Response (PR): 50% decrease in SPD (the sum of the products of the largest diameter and the perpendicular diameter for a tumor mass). Total responders = CR+PR |
| Secondary | RB1 Expression of Palbociclib | Up to 4 days | Median (min,max) of RB1 expression of palbociclib by study part and dose level |
| Secondary | Phospho-RB1 Expression of Palbociclib | Up to 4 days | Median (min,max) of Phospho-RB1 expression of palbociclib by study part and dose level |
| Secondary | Cyclin D3 Expression of Palbociclib | Up to 4 days | Median (min,max) of Cyclin D3 expression of palbociclib by study part and dose level |
| Secondary | CDK4 Expression of Palbociclib | Up to 4 days | Median (min,max) of CDK4 expression of palbociclib by study part and dose level |
| Secondary | CDK6 Expression of Palbociclib | Up to 4 days | Median (min,max) of CDK6 expression of palbociclib by study part and dose level |
| Secondary | p27Kip1 Expression of Palbociclib | Up to 4 days | Median (min,max) of p27Kip1 expression of palbociclib by study part and dose level |
| Secondary | Ki67 Biological Activity of Palbociclib | Up to 32 days | Median (min,max) of CD1a biological activity of palbociclib |
| Secondary | DAPI Biological Activity of Palbociclib | up to 26 months | Median (min,max) of DAPI biological activity of palbociclib by study part and dose level |
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/NCT03792256/registered