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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01499849 | Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy | PHASE3 | COMPLETED | 532 | — | — | Feb 1, 2012 | May 1, 2014 | May 19, 2016 | 1 | United States |
| NCT01500213 | Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy | PHASE3 | COMPLETED | 555 | — | — | Feb 1, 2012 | Mar 1, 2014 | Mar 2, 2016 | 1 | United States |
| NCT01500226 | Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy | PHASE3 | COMPLETED | 1,369 | — | — | Feb 1, 2012 | Feb 1, 2014 | Mar 2, 2016 | 1 | United States |
| NCT02434861 | An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin; Sulfasalazine; and the Cooperstown Cocktail (Midazolam, Omeprazole, Warfarin, Caffeine, and Dextromethorphan in Healthy Subjects | PHASE1 | COMPLETED | 102 | — | — | May 1, 2015 | Aug 1, 2015 | Aug 25, 2015 | 1 | United States |
| NCT02382666 | A Phase 1, 2-Part, Single Ascending Dose Assessment of the Safety, Tolerability, and Pharmacokinetics of Rolapitant Intravenous in Healthy Volunteers | PHASE1 | COMPLETED | 100 | — | — | Jan 1, 2015 | Aug 1, 2015 | Aug 25, 2015 | 1 | United States |
| NCT02285647 | An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant | PHASE1 | COMPLETED | 138 | — | — | Sep 1, 2014 | May 1, 2015 | Aug 25, 2015 | 1 | United States |
The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (\>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving HEC. The primary outcome will be based on complete response (defined as no emetic episodes and no rescue medication) in the delayed phase (\>24 to 120 hours).
To evaluate the effect of Rolapitant on the PK of probe substrates
To evaluate the effect of Rolapitant on the PK of probe substrates
To evaluate the safety and tolerability of rolapitant IV (30 minutes infusion) in healthy adult volunteers as assessed by the incidence and severity of AEs
To evaluate the safety and tolerability of rolapitant IV (30 minutes infusion) to an expanded cohort of healthy adult volunteers at the highest safe and well-tolerated dose established in Part 1 as assessed by the incidence and severity of AEs.
| Arm | Type | Description |
|---|---|---|
| Rolapitant | EXPERIMENTAL | Day 1: Rolapitant (200 mg PO) + Granisetron (10 mcg/kg IV) + dexamethasone (20 mg PO) Days 2-4: Dexamethasone (8 mg PO) will be administered orally BID. |
| Placebo + Granisetron + Dexamethasone | PLACEBO_COMPARATOR | Day 1: Placebo + Granisetron (10 mcg/kg IV)+ dexamethasone (20 mg PO) Days 2-4: Dexamethasone (8 mg PO) will be administered orally BID. |
| Part A | EXPERIMENTAL | Rolapitant IV and Digoxin |
| Part B | EXPERIMENTAL | Rolapitant IV and Sulfasalazine |
| Part C | EXPERIMENTAL | Rolapitant IV and Cooperstown Cocktail |
| Rolapitant Cohort 1 | EXPERIMENTAL | Investigational Product: Rolapitant Dose 1 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution |
| Rolapitant Cohort 2 | EXPERIMENTAL | Investigational Product: Rolapitant Dose 2 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution |
| Rolapitant Cohort 3 | EXPERIMENTAL | Investigational Product: Rolapitant Dose 3 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution |
| Rolapitant Cohort 4 | EXPERIMENTAL | Investigational Product: Rolapitant Dose 4 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution |
| Rolapitant Cohort 5 | EXPERIMENTAL | Investigational Product: Rolapitant Dose 5 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution |
| Rolapitant Cohort 6 | EXPERIMENTAL | Investigational Product: Rolapitant Dose 6 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution |
| Rolapitant - Oral | EXPERIMENTAL | Investigational Product: Rolapitant Dose: 200 mg (4 x 50mg) Route of Administration: Oral Dosage Form: Capsule Dosing Condition: Fasted (10 hours overnight) |
| Rolapitant - IV | EXPERIMENTAL | Investigational Product: Rolapitant Dose: 185 mg Route of Administration: IV (30 minutes) Dosage Form: 2 mg/mL solution Dosing Condition: Fasted (10 hours overnight) |
| Name | Type | Description |
|---|---|---|
| Rolapitant | DRUG | (4 X 50 mg capsules) 200 mg PO |
| Granisetron | DRUG | 10 mcg/kg IV |
| dexamethasone | DRUG | 20 mg PO and 8 mg PO |
| Placebo | DRUG | (4 X 0 mg capsules) 0 mg PO |
| Digoxin | DRUG | P-gp substrate |
| Sulfasalazine | DRUG | BCRP substrate |
| Cooperstown Cocktail | DRUG | Midazolam, omeprazole, warfarin, caffeine, and dextromethorphan |
| Rolapitant - Oral | DRUG | Oral Treatment A Investigational Product: Rolapitant Dose: 200 mg (4 x 50 mg) Route of Administration: Oral Dosage Form: Capsule Dosing Condition: Fasted (10 hours overnight) |
| Rolapitant - IV | DRUG | IV Treatment B Investigational Product: Rolapitant Dose: 185 mg Route of Administration: IV (30 minutes) Dosage Form: 2 mg/mL solution Dosing Condition: Fasted (10 hours overnight) |
Inclusion Criteria: * 18 years of age or older, of either gender, and of any race * has never been treated with cisplatin and is to receive the first course of cisplatin-based chemotherapy (≥60 mg/m2) * Karnofsky performance score of ≥60 * Predicted life expectancy of ≥4 months * Adequate bone marr...