Trial · NCT00958477
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 35 of 35
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval (AUCtau) of EMD 525797 After Third Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96,168, 336 hours post third infusion at Week 5 | Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours). |
| Secondary | Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of EMD 525797 After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | Area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is elimination rate constant. |
| Secondary | Peak Trough Fluctuation Over One Dosing Interval at Steady State (%PTF) of EMD 525797 After Third Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5 | The peak trough fluctuation over one dosing interval at steady state, calculated as PTF (%) = ( \[ Cmax - Cmin \] / Cav )\*100 |
| Secondary | Mean Residence Time of Drug in the Body (MRT) of EMD 525797 After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | Mean residence time of drug in the body calculated as: AUMC0-inf / AUC0-inf, where AUMC0-inf is the area under the first moment curve from time zero to infinity. Where AUC0-inf is area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above lower limit of quantification (LLQ) and λz is elimination rate constant. |
| Secondary | Apparent Volume of Distribution at Steady State (Vss) of EMD 525797 After Third Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5 | Apparent volume of distribution at steady-state was reported. Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. |
| Secondary | Accumulation Ratio Of Cmax (R_Cmax) | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 and Week 5 | Accumulation ratio for Cmax was calculated as Cmax, after third dose/Cmax, after first dose. |
| Secondary | Accumulation Ratio of AUC (R_AUC) | pre-dose, end of infusion, 4, 8, 24, 48, 96,168 hours post-infusion at Week 1 and pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336 hours post third infusion at Week 5 | Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at third dose divided by area under the serum concentration-time curve within one complete dosing interval at first dose. |
| Secondary | Number of Subjects With Best Overall Response (BOR) | Week 6, Week 19, Overall (Baseline Up to 394 days) | Number of subjects with BOR in each category (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD:defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study. |
| Secondary | Progression-free Survival (PFS) as Per Prostate Cancer Clinical Trials Working Group 1 (PCWG1) and Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria | Baseline up to 394 days | PFS PCWG1 criteria: time from the day treatment is initiated up to progression (for subject's whose prostate specific antigen \[PSA\] level did not decrease after baseline, progression defined as 50% PSA increase relative to baseline; for subject's whose PSA decreased after baseline, progression defined as 50% PSA increase relative to nadir \[smallest PSA value post-baseline\]. Progression was confirmed if progression criterion was met in next 2 assessments as well.) PFS PCWG2 criteria: time from study entry to disease progression or death. Progression was defined as first appearance of progression according to PSA (for subject's whose PSA decreased after baseline, progression was defined as 25% PSA increase relative to nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well; for subject's whose PSA did not decrease after baseline, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline). |
| Secondary | Time to Progression (TTP) | Baseline up to disease progression up to a maximum of 13.1 months | TTP was calculated as the time between the date of imaging for the earliest visit where progressive disease was detected and the first dose date plus 1 day. Participants without event are censored on the date of last tumor assessment. |
| Secondary | Number of Subjects With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score | Baseline up to 394 days | ECOG performance status measured to assess subject's performance status on a scale of 0 to 4, where 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair. ECOG performance status was reported in terms of number of subjects with Baseline value vs. worst post-baseline value (i.e. highest score) combination. |
| Secondary | Number of Subjects With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Best Post-baseline Score | Baseline up to 394 days | ECOG performance status measured to assess subject's performance status on a scale of 0 to 4, where 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair. ECOG performance status was reported in terms of number of subjects with Baseline value vs. best post-baseline value (i.e. lowest score) combination. |
| Secondary | Total Pain Score Using Brief Pain Inventory-Short Form (BPI-sf) | Screening; Baseline; Week 3, 5, 7; Follow-up (FUP) Week 11, 15, 19, 23, 27, 31, 35, 39, 43, 47, 51, 55, 59, 63, 67, 71, 75; End of treatment (EOT; maximum up to 380 days) and EOS (maximum up to 394 days) | BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf has 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10;'0=No pain and 10=Pain as bad as you can imagine'.Total score is reported as average of individual questions ranges from 0 to 10, with lower scores being indicative of less pain or pain interference.Data was not available for "EMD 525797 250 mg" arm for FUP Weeks 15, 19, 23, 27, 31, 35, 39, 43, 47, 51, 55, 59, 63, 67, 71, 75 and "EMD 525797 1000 mg" arm for FUP Weeks 47, 51, 55, 59, 63, 67, 71 and "EMD 525797 1500 mg arm" for FUP Weeks 35, 39, 43, 47, 51, 55, 59, 63, 67, 71, 75 respectively as no subjects were evaluable at the specified FUP visits. |
| Secondary | Maximum Percent Change From Baseline in Prostate Specific Antigen (PSA) Level | Baseline up to 394 days | Maximum percent change from Baseline in PSA Level during the study was reported. |
| Secondary | Minimum Percent Change From Baseline in PSA Level | Baseline up to 394 days | Minimum percent change from Baseline in PSA Level during the study was reported. |
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.
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