E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patient is scheduled to receive his/her first course of cisplatin chemotherapy for a documented solid malignancy at a dose of ≥ 70 mg/m2. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10054133 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Objectives: (1) To compare the single-dose fosaprepitant dimeglumine regimen and the aprepitant regimen with respect to efficacy in the first cycle of cisplatin-based HEC. (2) To evaluate the safety and tolerability of the single-dose fosaprepitant dimeglumine regimen for CINV. |
|
E.2.2 | Secondary objectives of the trial |
(1) To compare the single-dose fosaprepitant dimeglumine regimen and the aprepitant regimen in terms of the proportion of patients with a complete response (no vomiting and no use of rescue therapy) in the delayed phase (25 to 120 hours following initiation of cisplatin). (2) To compare the single-dose fosaprepitant dimeglumine regimen and the aprepitant regimen in terms of the proportion of patients with no vomiting overall (in the 120 hours following initiation of cisplatin). |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Patient is female or male, and is ≥18 years of age. 2. Patient is scheduled to receive his/her first course of cisplatin chemotherapy for a documented solid malignancy at a dose of ≥ 70 mg/m2. 3. Patient is able to understand study procedures and agrees to participate in the study by giving written informed consent. 4. Patient has a predicted life expectancy ≥ 3 months. 5. Patient has a Karnofsky score of ≥ 60 (Appendix 6.2). 6. Premenopausal female patients must demonstrate a negative urine pregnancy test to meet eligibility (based on kits provided by central laboratory) at the prestudy visit, and agree to use a double-barrier form of contraception for at least 14 days prior to, throughout, and for at least 1 month following the last dose of study medication. If the urine pregnancy test is negative, then the patient can be enrolled. However, if the urine pregnancy test is positive, the patient can be enrolled only if a subsequent serum pregnancy test is negative. Women taking oral contraceptive agents must agree to add a barrier form of contraception. Abstinence is also considered an acceptable form of contraception. If abstinence is not accepted locally, two acceptable birth control methods must be used. (Note: A female patient who is not of reproductive potential is eligible without requiring the use of contraception. A female patient who is not of reproductive potential is defined as one who has either: 1) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined by the laboratory, or 12 months of spontaneous amenorrhea); 2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy; or 3) bilateral tubal ligation). |
|
E.4 | Principal exclusion criteria |
1. Patient has symptomatic primary or metastatic CNS malignancy. 2. Patient has received or will receive radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 through Day 6. 3. Patient has vomited in the 24 hours prior to Treatment Day 1. 4. Patient has an active infection (e.g., pneumonia), any uncontrolled disease (e.g., diabetic ketoacidosis, pre-existing gastrointestinal conditions/ gastrointestinal obstruction) except for malignancy, or a history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk in administering study drug to the patient. 5. Patient currently uses any illicit drugs, including marijuana, or has current evidence of alcohol abuse (defined using DSM-IV criteria) as determined by the investigator. 6. Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry. 7. Patient will receive stem cell rescue therapy in conjunction with course of cisplatin chemotherapy. 8. Patient has a history of hypersensitivity to aprepitant, ondansetron, or dexamethasone (Attachments 3, 4, and 5). 9. Patient is pregnant or breast-feeding. (Patients of childbearing potential are required to have a negative pregnancy test prior to entering the study; see inclusion criterion 6.) 10. Patient has participated in a study with aprepitant or has taken a non-approved (investigational) drug within the last 4 weeks. 11. Patient is to receive multiple-day chemotherapy with cisplatin in a single cycle. 12. Patient is to receive chemotherapy of moderate or high emetogenicity (per Hesketh Classification of Emetogenic Chemotherapy Agents; Appendix 6.3) during the 6 days prior to the cisplatin infusion and/or during the 6 days following cisplatin infusion. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To compare the single-dose fosaprepitant dimeglumine regimen and the aprepitant regimen with respect to efficacy in the first cycle of cisplatin-based HEC. (2) To evaluate the safety and tolerability of the single-dose fosaprepitant dimeglumine regimen for CINV. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |