Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Casopitant · 3 trials · 5 indications
Complete response defined as no vomiting or retching and no rescue therapy during the first 24 hours following placement of the last suture/staple. Vomiting defined as the forceful expulsion of gastrointestinal contents through the mouth or nose. Retching defined as the labored, spasmodic, rhythmic contraction of the respiratory and abdominal muscles in an attempt to vomit that is not productive of gastrointestinal contents (also known as "dry heaves"). Study participants who receive antiemetic rescue medication(s) during the initial 24 hours was considered treatment failures.
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
| Arm | Type | Description |
|---|---|---|
| Control | PLACEBO_COMPARATOR | ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV on Day 1 + placebo |
| Single dose oral | EXPERIMENTAL | ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV + casopitant 150 mg on Day 1 |
| 3-day oral | EXPERIMENTAL | ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV + casopitant 150 mg on Day 1 + 50 mg on days 2 \& 3 |
| 3-day IV/oral | EXPERIMENTAL | ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV on Day 1 + 90 mg IV casopitant on day 1 and 50 mg oral casopitant on days 2 \& 3 |
| Subjects receiving casopitant | EXPERIMENTAL | Eligible subjects will receive a 100 milligrams oral dose of casopitant once daily for five consecutive days. |
| Name | Type | Description |
|---|---|---|
| Casopitant (GW679769) oral tablets | DRUG | - |
| Casopitant (GW679769) intravenous | DRUG | - |
| Dexamethasone intravenous | DRUG | - |
| Ondansetron oral tablets | DRUG | - |
| placebo | DRUG | casopitant placebo |
| casopitant | DRUG | - |
Inclusion criteria: * A subject will be considered eligible for inclusion in this study only if all of the following criteria apply: * Subject understands the nature and purpose of this study and the study procedures and has signed an informed consent form for this study to indicate this understand...
Casopitant is an investigational small molecule being developed for nausea and vomiting, including chemotherapy-induced nausea and vomiting and postoperative nausea and vomiting. It is in Phase 3 clinical development and has not been approved by the FDA.
Casopitant is being developed by GSK plc, traded on the New York Stock Exchange under the ticker GSK. The company has completed seven clinical trials for the drug with a total enrollment of 1,858 participants.
Casopitant is in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. All seven clinical trials for Casopitant have been completed, with no active trials currently ongoing.
Casopitant has completed seven clinical trials, including NCT00404274, NCT00437229, NCT00440128, and NCT00511823. These trials studied the drug's effects and safety in healthy volunteers and cancer patients, including interactions with warfarin, dexamethasone, ondansetron, docetaxel, and other medications.
Yes, Casopitant is also known as GW679769. Clinical trials for the drug, such as NCT00404274, reference this alternative name in their titles, confirming that both names refer to the same investigational compound.