Page last updated: 2024-10-20

pteridines and Nausea

pteridines has been researched along with Nausea in 2 studies

Nausea: An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.

Research Excerpts

ExcerptRelevanceReference
"Volasertib is a potent, selective, cell cycle kinase inhibitor that induces mitotic arrest and apoptosis by targeting Polo-like kinase."2.80A Randomized, Open-Label Phase II Trial of Volasertib as Monotherapy and in Combination With Standard-Dose Pemetrexed Compared With Pemetrexed Monotherapy in Second-Line Treatment for Non-Small-Cell Lung Cancer. ( Blais, N; Chu, Q; Ellis, PM; Gu, Y; Hirsh, V; Leighl, NB; Liu, D; Pilz, K; Reaume, MN; Sadrolhefazi, B; Wierzbicki, R, 2015)
"BI 2536 is a potent, highly selective inhibitor of polo-like kinase (Plk) 1."2.78A phase I open-label dose-escalation study of intravenous BI 2536 together with pemetrexed in previously treated patients with non-small-cell lung cancer. ( Chu, QS; Ellis, PM; Fritsch, H; Gaschler-Markefski, B; Gyorffy, S; Laurie, SA; Leighl, N; Munzert, G, 2013)

Research

Studies (2)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's2 (100.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Ellis, PM2
Leighl, NB1
Hirsh, V1
Reaume, MN1
Blais, N1
Wierzbicki, R1
Sadrolhefazi, B1
Gu, Y1
Liu, D1
Pilz, K1
Chu, Q1
Chu, QS1
Leighl, N1
Laurie, SA1
Fritsch, H1
Gaschler-Markefski, B1
Gyorffy, S1
Munzert, G1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomised Open-label Phase II Trial of BI 6727 Monotherapy and BI 6727 in Combination With Standard Dose Pemetrexed Compared to Pemetrexed Monotherapy in Second Line Non-small Cell Lung Cancer[NCT00824408]Phase 2143 participants (Actual)Interventional2009-03-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

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

InterventionmL/min (Geometric Mean)
Volasertib 250 mg + Pemetrexed 500 mg/m254.4
Volasertib 300 mg + Pemetrexed 500 mg/m269.1

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

Interventionng/mL (Geometric Mean)
Volasertib 250 mg + Pemetrexed 500 mg/m2131000
Volasertib 300 mg + Pemetrexed 500 mg/m2115000

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

Interventionng/mL (Geometric Mean)
Volasertib 250 mg + Pemetrexed 500 mg/m2554
Volasertib 300 mg + Pemetrexed 500 mg/m2635
Volasertib 300 mg565

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

Interventionweeks (Median)
Randomization Phase: Volasertib 300 mg23.0
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m219.6
Randomization Phase: Pemetrexed 500 mg/m223.4

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.

Interventionparticipants (Number)
Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m21
Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m21

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

Interventionmonths (Median)
Randomization Phase: Volasertib 300 mg22.9
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m217.1
Randomization Phase: Pemetrexed 500 mg/m217.4

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

Interventionmonths (Median)
Randomization Phase: Volasertib 300 mg1.4
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m23.3
Randomization Phase: Pemetrexed 500 mg/m25.3

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

InterventionmL/min (Geometric Mean)
Volasertib 250 mg + Pemetrexed 500 mg/m2782
Volasertib 300 mg + Pemetrexed 500 mg/m2882
Volasertib 300 mg867

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

InterventionLitres (Geometric Mean)
Volasertib 250 mg + Pemetrexed 500 mg/m29.40
Volasertib 300 mg + Pemetrexed 500 mg/m213.1

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

InterventionLitres (Geometric Mean)
Volasertib 250 mg + Pemetrexed 500 mg/m26730
Volasertib 300 mg + Pemetrexed 500 mg/m26750
Volasertib 300 mg6230

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

,,,,
Interventionparticipants (Number)
Haemoglobin - LowWhite blood cell ct. - LowWhite blood cell ct. - HighPlatelets - LowPlatelets - HighNeutrophils - LowLymphocytes - LowAST/GOT, SGOT - HighALT/GPT, SGPT - HighAlkaline phosphatase - HighCreatinine - HighBilirubin, total - High
Randomization Phase: Pemetrexed 500 mg/m21412123122236501
Randomization Phase: Volasertib 300 mg1615183131600001
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m221250302322610031
Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2140004400001
Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2220112411000

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

,,,,
Interventionpercentage of participants (Number)
Complete response (CR)Partial response (PR)
Randomization Phase: Pemetrexed 500 mg/m20.010.6
Randomization Phase: Volasertib 300 mg0.08.1
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m20.021.3
Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m20.016.7
Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m20.050.0

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

,,,,
Interventionparticipants (Number)
CTCAE Grade 1CTCAE Grade 2CTCAE Grade 3CTCAE Grade 4CTCAE Grade 5
Randomization Phase: Pemetrexed 500 mg/m26181550
Randomization Phase: Volasertib 300 mg612863
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m22181952
Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m200330
Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m202310

Trials

2 trials available for pteridines and Nausea

ArticleYear
A Randomized, Open-Label Phase II Trial of Volasertib as Monotherapy and in Combination With Standard-Dose Pemetrexed Compared With Pemetrexed Monotherapy in Second-Line Treatment for Non-Small-Cell Lung Cancer.
    Clinical lung cancer, 2015, Volume: 16, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Carcinoma, Non-Small-Cell Lung; Cell Cycle Proteins; Drug Dosage Cal

2015
A phase I open-label dose-escalation study of intravenous BI 2536 together with pemetrexed in previously treated patients with non-small-cell lung cancer.
    Clinical lung cancer, 2013, Volume: 14, Issue:1

    Topics: Administration, Intravenous; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma,

2013