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The purpose of the study is to evaluate the effect of the study drug (GW679769) on a commonly used chemotherapy drug (docetaxel) which will be given I.V. Blood samples will be taken to see if the GW679769 alters the blood levels of the chemotherapy. The study will last about 2 weeks with a final follow-up visit 6 weeks later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel | Active Comparator | Docetaxel |
|
| Docetaxel/Casopitant | Experimental | Docetaxel/Casopitant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel |
| |
| Casopitant/Docetaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of study drugs will be taken on Day 1 & 8. | Plasma samples of study drugs | taken on Day 1 & 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety is evaluated by: -AEs monitored at each visit | starting at Day 1. | |
| -Physical exam, vital signs, & ECOG performance status score | at Screening, Day 1,8,&15. | |
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Inclusion Criteria:
Male or female
18 years of age
A female is eligible to enter and participate in this study if she is of:
Non-child-bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had at least one of the following:
Childbearing potential, has a negative serum pregnancy or negative urine pregnancy test within 24 hours prior to administration of the first dose of study medication and agrees to one of the following:
Histologically confirmed malignant solid tumor and is scheduled to receive at least 2 courses of chemotherapy with docetaxel as a single intravenous dose of 20 to 40 mg/m2 given over a duration of one hour and repeated weekly.
Received eight or fewer previous doses of docetaxel. Subjects that have received more than eight doses of docetaxel must receive permission from the GSK medical monitor in order to be eligible for the study.
ECOG performance status score of less than or equal to 2
NOTE: If the subject's performance status deteriorates between the screening Visit and the time of first dose of study drug to a score > 2, the subject will be excluded from the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Hot Springs | Arkansas | 71913 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20556613 | Background | Dandamudi UB, Adams LM, Johnson B, Bauman J, Morris S, Murray S, Webb RT, Gartner E, Hohl R, Lewis LD. Lack of effect of casopitant on the pharmacokinetics of docetaxel in patients with cancer. Cancer Chemother Pharmacol. 2011 Apr;67(4):783-90. doi: 10.1007/s00280-010-1381-2. Epub 2010 Jun 17. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| NKV100781 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| C531951 | casopitant |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Drug |
Casopitant/Docetaxel |
|
|
| -ECG |
| at Screening & Day 15. |
| -Serum Pepsinogen levels monitored | at Screening & Followup |
| Terminal half-life (t1/2, as data permit), AUC(0-t), volume of distribution at steady state (Vdss), and clearance (Cl) of docetaxel | on Day 1 and 8. |
| Lowest measured absolute neutrophil count. | on Day 1 and 8 |
| Physical exam findings, blood pressure, heart rate, clinical laboratory tests, clinical monitoring/observation, and adverse events reporting. | on Day 1 and 8 |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| GSK Investigational Site | Detroit | Michigan | 48201 | United States |
| GSK Investigational Site | Lebanon | New Hampshire | 03756 | United States |
| Results for study NKV100781 can be found on the GSK Clinical Study Register. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| NKV100781 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV100781 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV100781 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV100781 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV100781 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV100781 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |