Trial · NCT01543763
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose limiting toxicity (DLT) | up to 4 weeks | A dose limiting toxicity (DLT) will be defined as any predetermined adverse events occurring during Cycle 1 when association to therapy that is part of this study is related or possibly related |
| Primary | Maximum Tolerated Dose (MTD) | up to 4 weeks | The maximum tolerated dose (MTD) will be defined as the highest tested dose level at which less than 33% of patients experience DLT in Cycle 1 |
| Secondary | Establish the volume of distribution of PCI-24781, pazopanib and the combination of the two drugs. | up to 2 months | Noncompartmental pharmacokinetic profile of PCI-24781, pazopanib and the combination will be assessed by measuring and calculating the volume of distribution (Vd) |
| Secondary | Establish the bioavailability of PCI-24781, pazopanib and the combination of the two drugs. | up to 2 months | Noncompartmental pharmacokinetic profile of PCI-24781, pazopanib and the combination will be assessed by measuring and calculating the bioavailability (F). |
| Secondary | Establish the clearance of PCI-24781, pazopanib and the combination of the two drugs. | up to 2 months | Noncompartmental pharmacokinetic profile of PCI-24781, pazopanib and the combination will be assessed by measuring and calculating clearance (CL) |
| Secondary | Establish the half-life of PCI-24781, pazopanib and the combination of the two drugs. | up to 2 months | Noncompartmental pharmacokinetic profile of PCI-24781, pazopanib and the combination will be assessed by measuring and calculating the half-life (t1/2) |
| Secondary | Establish the area under the curve (AUC) of PCI-24781, pazopanib and the combination of the two drugs. | up to 2 months | Noncompartmental pharmacokinetic profile of PCI-24781, pazopanib and the combination will be assessed by measuring and calculating the AUC |
| Secondary | Clinical Benefit Rate (CBR) | approximately 4 months | Clinical Benefit Rate=Complete Response (CR)+Partial Response (PR)+Stable Disease (SD) is defined as the best response at any time or maintaining stable disease for at least 12 weeks and will be evaluated by imaging criteria RECIST 1.1. A patient with unknown or missing response will be treated as a non-responder. Patients are expected to receive treatment for at least 2 Cycles, at which time the first evaluation for efficacy will occur. Exact methods for calculated confidence intervals will be utilized. |
| Secondary | Objective response rate (ORR) | approximately 4 months | Objective response rate is defined as the percentage or proportion of patients with a confirmed complete or partial response (CR+PR) as defined by RECIST 1.1 divided by the total number of patients on study. Patients are expected to receive treatment for at least 2 Cycles, at which time the first evaluation for efficacy will occur. A patient with unknown or missing response will be treated as a non-responder. Exact methods for calculated confidence intervals will be utilized. |
| Secondary | Progression-free Survival (PFS) | Up to 1 year | Time to progression will be calculated as the time from first dose of the combination until the earliest date of documented disease relapse, progression, or death from any cause. If the patient does not have a documented date of progression or death, then PFS will be censored at the date of last adequate assessment. PFS will be summarized using Kaplan-Meier method and lifetables, including the 1-year point estimates with standard errors. |
| Secondary | Overall survival (OS) | Up to 1 year | Overall survival will be calculated as the time from first dose of the combination until the earliest date of documented study discontinuation or death from any cause. If the patient does not have a documented date of death, then OS will be censored at the date of last adequate assessment. OS will be summarized using Kaplan-Meier method and lifetables, including the 1-year point estimates with standard errors. |
| Secondary | Duration of Response (DoR) | Up to 1 year | Duration of Response is defined, for the subset of patients with a confirmed complete or partial response, as the time from first documented evidence of CR or PR until first documented disease progression or death due to any cause. Only the subset of patients who show a confirmed complete or partial tumor response will be included. Censoring rules for duration of response will follow the rules for PFS |
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/NCT01543763/registered