pteridines and Fatigue

pteridines has been researched along with Fatigue in 2 studies

Fatigue: The state of weariness following a period of exertion, mental or physical, characterized by a decreased capacity for work and reduced efficiency to respond to stimuli.

Research

Studies (2)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

CL of Pemetrexed

CL - total clearance of pemetrexed in plasma after IV administration (NCT00824408)
Timeframe: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion

Cmax of Pemetrexed

Cmax - maximum measured concentration of pemetrexed in plasma (NCT00824408)
Timeframe: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion

Cmax of Volasertib

Cmax - maximum measured concentration of volasertib in plasma. (NCT00824408)
Timeframe: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion

Duration of Overall Response

The duration of overall response was measured from the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since treatment began). The duration of overall CR was measured from the time measurement criteria were first met for CR until the first date that recurrent disease was objectively documented. Duration of disease control is presented here. (NCT00824408)
Timeframe: From the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented

Occurence of DLT

"Occurence of Dose-limiting toxicity (DLT). A DLT was defined as one or more of the following:~treatment-related CTCAE Grade 3 or 4 nonhematological toxicity (except emesis or diarrhea responding to supportive treatment).~treatment-related CTCAE Grade 4 neutropenia for ≥7 days and/or complicated by infection.~CTCAE Grade 4 thrombocytopenia." (NCT00824408)
Timeframe: Patients were treated for repeated 21-day treatment cycles until disease progression or intolerability of the trial drug, whichever occurred first.

Overall Survival (OS)

Overall survival (OS) was defined as the duration of time from randomization to time of death. (NCT00824408)
Timeframe: From randomization until time of death

Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First.

"Disease progression was defined according to the Response Evaluation Criteria in Solid Tumours (RECIST)) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occured first. For patients with known date of progression (or death): PFS [days] = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS [days, censored] = date of last imaging showing no progression - date randomization + 1 day.~The number of participants analysed displays the number of patients with an event (progression)." (NCT00824408)
Timeframe: From randomization until disease progression or death

Total Clearance (CL) of Volasertib

CL - total clearance of volasertib in plasma after IV administration (NCT00824408)
Timeframe: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion

Vss of Pemetrexed

Vss - apparent volume of distribution at steady state following IV administration of pemetrexed (NCT00824408)
Timeframe: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion

Vss of Volasertib

Vss - apparent volume of distribution at steady state following IV administration of volasertib (NCT00824408)
Timeframe: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion

Frequency of Patients With Possible Clinically Significant Abnormalities

Frequency of patients with possible clinically significant abnormalities (NCT00824408)
Timeframe: From first drug infusion until 21 days after last drug infusion, up to 1100 days

Objective Tumor Response, Defined as Complete Response (CR), and Partial Response (PR), Evaluated According to RECIST Criteria.

Objective tumor response, defined as complete response (CR), and partial response (PR), evaluated according to RECIST criteria. Evaluation of target lesions: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Evaluation of nontarget lesions: Complete Response (CR): disappearance of all nontarget lesions. (NCT00824408)
Timeframe: From first drug infusion until 21 days after last drug infusion, up to 1100 days

Occurrence and Intensity of AEs Graded According to CTCAE.

All patients were carefully monitored during and after each treatment cycle. Adverse events (AEs) were recorded and were graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE). (NCT00824408)
Timeframe: From first drug infusion until 21 days after last drug infusion, up to 1100 days

Trials

2 trials available for pteridines and Fatigue