Page last updated: 2024-10-20
pteridines and Cancer of the Urinary Tract
pteridines has been researched along with Cancer of the Urinary Tract in 2 studies
Research Excerpts
| Excerpt | Relevance | Reference |
|---|
| "In patients with tumors of the genitourinary tract or with hemopoietic neoplasms, urinary neopterin levels were correlated with the tumor burden and became normal when remission was achieved." | 1.27 | Urinary neopterin in the diagnosis and follow-up of neoplasia: a biochemical parameter to detect cell-mediated immune response. ( Fuchs, D; Hausen, A; Huber, C; Reibnegger, G; Wachter, H, 1984) |
Research
Studies (2)
| Timeframe | Studies, this research(%) | All Research% |
|---|
| pre-1990 | 1 (50.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 1 (50.00) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
Authors
| Authors | Studies |
|---|
| Stadler, WM | 1 |
| Vaughn, DJ | 1 |
| Sonpavde, G | 1 |
| Vogelzang, NJ | 1 |
| Tagawa, ST | 1 |
| Petrylak, DP | 1 |
| Rosen, P | 1 |
| Lin, CC | 1 |
| Mahoney, J | 1 |
| Modi, S | 1 |
| Lee, P | 1 |
| Ernstoff, MS | 1 |
| Su, WC | 1 |
| Spira, A | 1 |
| Pilz, K | 1 |
| Vinisko, R | 1 |
| Schloss, C | 1 |
| Fritsch, H | 1 |
| Zhao, C | 1 |
| Carducci, MA | 1 |
| Fuchs, D | 1 |
| Hausen, A | 1 |
| Huber, C | 1 |
| Reibnegger, G | 1 |
| Wachter, H | 1 |
Clinical Trials (1)
Trial Overview
| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| An Open-label, Single-arm, Phase II Trial of Intravenous BI 6727 in Patients With Locally Advanced, Metastatic or Recurrent Urothelial Cancer of the Bladder, Renal Pelvis, or Ureters After Failure of Prior Chemotherapy[NCT01023958] | Phase 2 | 50 participants (Actual) | Interventional | 2009-11-19 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial Outcomes
AUC0-∞ of Volasertib
Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of volasertib (NCT01023958)
Timeframe: 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion
| Intervention | ng*h/mL (Geometric Mean) |
|---|
| Volasertib (BI 6727) | 5470 |
CL of Volasertib
Total plasma clearance after intravascular administration (CL) of volasertib (NCT01023958)
Timeframe: 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion
| Intervention | mL/min (Geometric Mean) |
|---|
| Volasertib (BI 6727) | 914 |
Cmax of Volasertib
Maximum measured concentration in plasma (Cmax) of volasertib (NCT01023958)
Timeframe: 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion
| Intervention | ng/mL (Geometric Mean) |
|---|
| Volasertib (BI 6727) | 253 |
Disease Control Rate
Disease control rate. Disease control is defined as having a best overall response of complete response (CR), partial response (PR) or stable disease (SD). (NCT01023958)
Timeframe: From first drug administration until end of study, up to 2 years
| Intervention | Percentage of participants (Number) |
|---|
| Volasertib (BI 6727) | 40.0 |
Duration of Disease Control
Disease control is defined as having a best overall response of CR, PR, or SD. The duration of disease control is measured from the time of first response to progression or death whichever occurs first. (NCT01023958)
Timeframe: Time of first response to progression or death, up to 2 years
| Intervention | Weeks (Median) |
|---|
| Volasertib (BI 6727) | 27.0 |
Duration of Overall Response
The duration of overall response is measured from the time of first response (CR or PR) to progression or death whichever occurs first. (NCT01023958)
Timeframe: From the time of first response (CR or PR) to progression or death, up to 2 years
| Intervention | Weeks (Median) |
|---|
| Volasertib (BI 6727) | 41.0 |
Laboratory Investigation: Alkaline Phosphatase
Difference from baseline in laboratory parameter Alkaline phosphatase (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)
| Intervention | U/L (Mean) |
|---|
| Volasertib (BI 6727) | 35 |
Laboratory Investigation: ALT/GPT, SGPT
Difference from baseline in laboratory parameter Alanine aminotransferase(ALT)/GPT, SGPT (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)
| Intervention | U/L (Mean) |
|---|
| Volasertib (BI 6727) | 3 |
Laboratory Investigation: AST/GOT, SGOT
Difference from baseline in laboratory parameter Aspartate aminotransferase(AST)/GOT, SGOT (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)
| Intervention | U/L (Mean) |
|---|
| Volasertib (BI 6727) | 5 |
Laboratory Investigation: Creatinine
Difference from baseline in laboratory parameter Creatinine (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)
| Intervention | umol/L (Mean) |
|---|
| Volasertib (BI 6727) | 16 |
Laboratory Investigation: Haemoglobin
Difference from baseline in laboratory parameter Haemoglobin (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)
| Intervention | g/L (Mean) |
|---|
| Volasertib (BI 6727) | -19 |
Laboratory Investigation: Lymphocytes
Difference from baseline in laboratory parameter Lymphocytes (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)
| Intervention | 10^9 cells/L (Mean) |
|---|
| Volasertib (BI 6727) | -0.8 |
Laboratory Investigation: Neutrophils
Difference from baseline in laboratory parameter Neutrophils (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)
| Intervention | 10^9 cells/L (Mean) |
|---|
| Volasertib (BI 6727) | -1.9 |
Laboratory Investigation: Platelets
Difference from baseline in laboratory parameter Platelets (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)
| Intervention | 10^9 cells/L (Mean) |
|---|
| Volasertib (BI 6727) | -23 |
Laboratory Investigation: Total Bilirubin
Difference from baseline in laboratory parameter total Bilirubin (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)
| Intervention | umol/L (Mean) |
|---|
| Volasertib (BI 6727) | 4.7 |
Laboratory Investigation: White Blood Cell Count
Difference from baseline in laboratory parameter white blood cell count (NCT01023958)
Timeframe: Baseline and last value on treatment (up to 2 years)
| Intervention | 10^9 cells/L (Mean) |
|---|
| Volasertib (BI 6727) | -1.8 |
Objective Tumour Response According to RECIST Criteria
Objective tumor response, defined as complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. (NCT01023958)
Timeframe: From first drug administration until end of study, up to 2 years
| Intervention | Percentage of participants (Number) |
|---|
| Volasertib (BI 6727) | 14.0 |
Occurrence of Unacceptable Toxicity
Occurrence of unacceptable toxicity is defined by CTCAE as as drug related CTCAE Grade 3 or greater non-hematological toxicity (except emesis or diarrhea responding to supportive treatment); drug-related CTCAE Grade 4 neutropenia for seven or more days and / or complicated by infection; or drug-related CTCAE Grade 4 thrombocytopenia. (NCT01023958)
Timeframe: From first drug administration up to 21 days after final administration, up to 2 years
| Intervention | Percentage of participants (Number) |
|---|
| Volasertib (BI 6727) | 30 |
Overall Survival
"Overall survival (OS) is the time from first infusion to death. Patients who were alive at the time of analysis or lost to follow-up were censored at the last follow-up date when they were known to be alive.~Overall survival was analyzed with the Kaplan-Meier curve. Greenwood's variance estimate was used to form confidence intervals." (NCT01023958)
Timeframe: Time from first infusion to death, up to 2 years
| Intervention | Months (Median) |
|---|
| Volasertib (BI 6727) | 8.5 |
Progression-free Survival
"Progression-free survival (PFS) is the time from first treatment to the occurrence of tumor progression or death, whichever occurs first. Disease progression is defined according to the RECIST guideline but also includes the investigators' assessment which may, in some cases, include only clinical progression (deterioration of general health status per investigator). PFS was analyzed with the Kaplan-Meier curve. Greenwood's variance estimate was used to form confidence intervals.~Patients without evidence of disease progression were to be censored at the last image date." (NCT01023958)
Timeframe: Time from first treatment to the occurrence of tumor progression or death, up to 2 years
| Intervention | Weeks (Median) |
|---|
| Volasertib (BI 6727) | 6.1 |
t1/2 of Volasertib
Terminal half-life (t1/2) of volasertib (NCT01023958)
Timeframe: 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion
| Intervention | hours (Geometric Mean) |
|---|
| Volasertib (BI 6727) | 150 |
Tmax of Volasertib
Time from dosing to maximum measured concentration (Tmax) of volasertib (NCT01023958)
Timeframe: 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion
| Intervention | Hours (Median) |
|---|
| Volasertib (BI 6727) | 2.03 |
Vss of Volasertib
Apparent volume of distribution at steady state following intravascular administration (Vss) of volasertib (NCT01023958)
Timeframe: 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion
| Intervention | Litres (Geometric Mean) |
|---|
| Volasertib (BI 6727) | 7470 |
Occurrence and Intensity of AE's Graded According to CTCAE
"Occurrence and intensity of adverse events (AEs) graded according to Common Toxicity Criteria of Adverse Events (CTCAE).~The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE)." (NCT01023958)
Timeframe: From first drug administration until end of study, up to 2 years
| Intervention | Percentage of participants (Number) |
|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
|---|
| Volasertib (BI 6727) | 8.0 | 28.0 | 36.0 | 20.0 | 6.0 |
Trials
1 trial available for pteridines and Cancer of the Urinary Tract
Other Studies
1 other study available for pteridines and Cancer of the Urinary Tract