Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00601172 | A Study Of IV Casopitant For The Prevention Of Chemotherapy Induced Nausea And Vomiting. | PHASE3 | COMPLETED | 710 | — | — | Mar 10, 2008 | Apr 13, 2009 | Jan 17, 2018 | 96 | United States, Belgium +9 |
| NCT00431236 | A Study of the Drug Casopitant for the Prevention of Nausea Caused By Cisplatin-Based Highly Emetogenic Chemotherapy | PHASE3 | COMPLETED | 810 | — | — | Nov 6, 2006 | Oct 9, 2007 | Aug 22, 2017 | 80 | Argentina, Belgium +20 |
| NCT00511823 | The Pharmacokinetic Interaction Between Oral Casopitant and Oral Dolasetron, Granisetron or Rosiglitazone in Subjects | PHASE1 | COMPLETED | 16 | — | — | Jul 23, 2007 | Sep 21, 2007 | Aug 3, 2017 | 1 | United States |
| NCT00440128 | The Effects Of GW679769 (Casopitant) On The Pharmacokinetics Of Docetaxel In Subjects With Cancer | PHASE1 | COMPLETED | 12 | — | — | May 4, 2007 | Jul 17, 2008 | Aug 4, 2017 | 4 | United States |
| NCT00460707 | A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults | PHASE1 | COMPLETED | 85 | — | — | Apr 16, 2007 | Aug 27, 2007 | Aug 3, 2017 | 3 | United States |
| NCT00437229 | A Study to Assess the Safety & Interaction Between GW679769, Dexamethasone, & Ondansetron When Taken by Healthy Adults | PHASE1 | COMPLETED | 37 | — | — | Feb 19, 2007 | May 15, 2007 | Nov 13, 2017 | 1 | United States |
| NCT00404274 | A Study Testing the Effect and Safety of Casopitant (GW679769) While Taking Warfarin in Healthy Human Volunteers | PHASE1 | COMPLETED | 97 | — | — | Nov 1, 2006 | Mar 18, 2007 | Aug 9, 2017 | 2 | United States |
Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. The overall phase began at the start of the administration of the oxaliplatin infusion. Percentage of participants who achieved a complete response in the overall phase (0-120 hours) are presented.
Complete response was defined as no vomiting/retching and no rescue therapy) over the first 120 hours following the initiation of their first cycle of a cisplatin-based HEC regimen. Vomiting was defined as the forceful expulsion of gastrointestinal contents through the mouth or nose. Retching was defined as the labored, spasmodic, rhythmic contraction of the respiratory and abdominal muscles in an attempt to vomit, that was not productive of gastrointestinal contents (also known as "dry heaves").
Plasma samples of study drugs
| Arm | Type | Description |
|---|---|---|
| Control | PLACEBO_COMPARATOR | Placebo + standard antiemetics |
| Single Dose IV | EXPERIMENTAL | Casopitant + standard antiemetics |
| Subjects in Part A | EXPERIMENTAL | Subjects will receive 100 milligrams (mg) of oral dolasetron once daily for 3 days during treatment period 1. In treatment period 2, subjects will receive 100 mg oral dolasetron once daily on days 1, 2 and 3 along with 150 mg oral casopitant on day 1 and 50 mg oral casopitant on days 2 and 3. The treatment periods will be separated by will be separated by a 5 - 14 day wash-out period. |
| Subjects in Part B | EXPERIMENTAL | Subjects will receive 2 mg of oral granisetron once daily for 3 days during treatment period 1. In treatment period 2, subjects will receive 2 mg oral granisetron once daily on days 1, 2 and 3 along with 150 mg oral casopitant once daily on day 1 and 50 mg oral casopitant once daily on days 2 and 3. The treatment periods will be separated by will be separated by a 5 - 14 day wash-out period. |
| Subjects in Part C | EXPERIMENTAL | Subjects will receive 4 mg of oral rosiglitazone once daily for 3 days during treatment period 1. In treatment period 2, subjects will receive 4 mg oral rosiglitazone once daily on days 1, 2 and 3 along with 150 mg oral casopitant once daily on day 1 and 50 mg oral casopitant once daily on days 2 and 3. The treatment periods will be separated by will be separated by a 5 - 14 day wash-out period. |
| Docetaxel | ACTIVE_COMPARATOR | Docetaxel |
| Docetaxel/Casopitant | EXPERIMENTAL | Docetaxel/Casopitant |
| Cohort 1 | EXPERIMENTAL | All subjects in Cohort 1 will receive ketoconazole 400 milligrams (mg) once daily on Day 1 to 9 and oral casopitant 150 mg on Day 4 and 50 mg on Day 5 and Day 6 of treatment period 1. After a washout period of 21 days, subjects will be administered oral casopitant 150 mg on Day 1 and 50 mg on Day 2 and Day 3 of treatment period 2. |
| Cohort 2, Group A | PLACEBO_COMPARATOR | Subjects will receive placebo once daily on Day 1 to Day 3 in treatment period 1. Subjects will receive ketoconazole 400 mg once daily on Day 1 to Day 9 and oral placebo once daily on Days 4, 5 and 6 in treatment period 2. There will be a 14-day washout period between treatment periods 1 and 2. |
| Cohort 2, Group B | EXPERIMENTAL | In treatment period 1, subjects will receive oral casopitant 150 mg on Day 1 and 50 mg on Days 2 and 3. In treatment period 2, they will be administered ketoconazole 400 mg once daily on Day 1 to Day 9 and oral casopitant 150 mg on Day 4 and 50 mg on Days 5 and 6. There will be a 14-day washout period between treatment periods 1 and 2. |
| Treatment regimen A | EXPERIMENTAL | In treatment regimen A subject will co-administer casopitant and warfarin over three-day period (Day 1 150 milligram per day \[mg/day\], Day 2 50 mg/day, Day 3 50 mg/day) and from Days 4 to 10 subject will administer only warfarin. |
| Treatment regimen B | EXPERIMENTAL | In treatment regimen B subject will co-administer casopitant 60 mg/day and warfarin for 14 days. |
| Treatment regimen C | EXPERIMENTAL | In treatment regimen C subject will co-administer warfarin and casopitant 30 mg/day for 14 days. |
| Name | Type | Description |
|---|---|---|
| Casopitant | DRUG | Experimental NK-1 receptor antagonist |
| Dexamethasone | DRUG | Standard antiemetics |
| Placebo | DRUG | Placebo to match IV casopitant |
| Ondansetron | DRUG | Standard antiemetics |
| Oral Casopitant (GW679769) | DRUG | - |
| IV Casopitant (GW679769) | DRUG | - |
| IV ondansetron hydrochloride | DRUG | - |
| Oral dexamethasone | DRUG | - |
| dolasetron | DRUG | The dose of oral dolasetron will be comprised of 100 mg (one 100 mg tablet or two 50 mg tablets). Dolasetron will be taken with 240 mL of water on an empty stomach following at least 2 hour fast. |
| granisetron | DRUG | The dose of oral granisetron will be comprised of 2 mg (two 1 mg tablets). Granisetron will be taken with 240 mL of water on an empty stomach following at least 2 hour fast. |
| rosiglitazone | DRUG | The dose of oral rosiglitazone will be comprised of 4 mg (two 2 mg tablets or one 4 mg tablet). Rosiglitazone will be taken with 240 mL of water on an empty stomach following at least 2 hour fast. |
| Docetaxel | DRUG | Docetaxel |
| Casopitant/Docetaxel | DRUG | Casopitant/Docetaxel |
| Casopitant 150 mg | DRUG | Casopitant 150 mg will be available as white, film-coated tablets. Casopitant tablets will be taken with 240 milliliters (mL) of water at room temperature on an empty stomach. |
| Ketoconazole | DRUG | Ketoconazole will be available as 200 mg tablets which will be taken with 240 mL of water on an empty stomach (after a 2 hour fast on Day 4 of Treatment Period 2 and after a 1 hour fast on all other dosing days). |
| Casopitant 150 mg matching placebo | DRUG | Casopitant 150 mg matching placebo will be available as white, film-coated tablets. |
| Casopitant 50 mg | DRUG | Casopitant 50 mg will be available as pale orange, film-coated tablets. Casopitant tablets will be taken with 240 mL of water at room temperature on an empty stomach. |
| Casopitant 50 mg matching placebo | DRUG | Casopitant 50 mg matching placebo will be available as pale orange, film-coated tablets. |
| Casopitant (GW679769) Oral Tablets | DRUG | Casopitant (GW679769) tablets will be available as white, film-coated tablets containing 50 mg of GW679769 as the mesylate salt for oral administration. |
| Warfarin oral tablets | DRUG | Warfarin will be available in the dose strength of 5 mg |
Inclusion Criteria: * A subject will be considered eligible for initial inclusion in this study, and progression into subsequent cycles of therapy within the study, only if all of the following criteria apply: * Subject understands the nature and purpose of this study and the study procedures and h...