Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3 Clinical Study Protocol: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Study of APF530 500 mg SC, Fosaprepitant 150 mg IV, and Dexamethasone vs. Ondansetron 0.15 mg/kg IV, Fosaprepitant 150 mg IV, and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy
Brief Summary: The primary study objective is to demonstrate the superiority of APF530 500 mg given subcutaneously (SC) compared with ondansetron 0.15 mg/kg given intravenously (IV) (up to a maximum of 16 mg) in the delayed-phase (\> 24-120 hours) complete response (CR) rate (defined as no emesis and no use of rescue medications) in subjects receiving highly emetogenic chemotherapy (HEC) as defined by the 2011 ASCO CINV guidelines


Options:
A: Inclusion criteria:

* Have a diagnosis of cancer and be chemotherapy naive.
* Must be scheduled to receive a chemotherapy treatment containing doxorubicin hydrochloride, epirubicin hydrochloride, cisplatin, carboplatin, or oxaliplatin (any dose or schedule) without concurrent radiotherapy or interferon treatment
* Chemotherapy may be for adjuvant, neoadjuvant, curative or palliative intent.
* Dose-dense regimens (e.g. chemotherapy with doxorubicin or epirubicin given every two weeks)are allowed.
* For the purposes of this study, Day 1 of chemotherapy will be defined as the day of administration of cisplatin, carboplatin, oxaliplatin, doxorubicin or epirubicin.
* Regimens with multiple-day doses of doxorubicin, epirubicin, cisplatin, carboplatin, oxaliplatin, dacarbazine, hexamethylmelamine, nitrosoureas, or streptozocin are not allowed. Chemotherapy agents, other than those listed above, may be given orally, intravenously, or by continuous infusion on one or multiple days.
* Able to understand English

Exclusion criteria:

* No symptomatic brain metastases
* No concurrent or impending bowel obstruction
* Regimens containing liposomal doxorubicin or cisplatin are not allowed.
* No concurrent pimozide, terfenadine, astemizole, or cisapride
* No concurrent doxorubicin hydrochloride liposome or cisplatin
* No concurrent multiple-day doses of dacarbazine, altretamine, nitrosoureas, streptozocin, cisplatin, carboplatin, or oxaliplatin
B: Inclusion Criteria:

* Subjects will be males or nonpregnant females who are 18-87 years of age at the time of enrollment.
* Subjects must have histologically or cytologically confirmed malignant disease.
* Subjects must be undergoing treatment with a HEC regimen according to the 2011 ASCO CINV guidelines for further details on the emetogenic classifications of chemotherapy agents for this study).
* A life expectancy \> 6 months
* Subjects must be able to receive standardized doses of dexamethasone as required in the protocol for the prevention of emesis.
* Subjects must be characterized as having Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Subjects must have adequate bone marrow, kidney, and liver function.
* Subjects must be able to swallow oral medications (pills) without difficulty.
* Subjects must be entering the first cycle of their current chemotherapy regimen.
* Subjects must be willing and able to comply with all testing and requirements defined in the protocol.
* Subjects must be able to provide voluntary, written, informed consent to participate in this study and must be able to fully understand the study requirements.
* Female subjects cannot be pregnant and must be adequately protected from conception for the duration of study, using at least one form of contraception. It is recommended that females and female partners of male subjects remain adequately protected from conception during the study and for up to 1 year following study participation.

Exclusion Criteria:

* Subject has a known hypersensitivity to granisetron or any 5-HT3 receptor antagonist.
* Subject has a history or presence of clinically significant abnormal 12-lead ECG or an ECG with QTc by Bazett's correction of \> 450 msec in men and \> 470 msec in women on the screening ECG.
* Subject has PR \> 240 msec, QRS \> 110 msec, or a history of prolongation of QT interval.
* Subject has a family history of long QT syndrome.
* Subject has a history of cardiac disease, including congenital long QT syndrome, angina, myocardial ischemia or infarction, congestive heart failure, myocarditis, or chest pain or dyspnea on exertion.
* Subject has an electrolyte disturbance, such as uncorrected hypokalemia/hyperkalemia, hypomagnesemia, or hypocalcemia.
* Subject has idiopathic cardiomyopathy, syncope, epilepsy, hypertrophic cardiomyopathy, or other clinically significant cardiac disease.
* Subject is pregnant or breast-feeding.
* Subject is planning to receive multiple-day chemotherapy.
* Subject has taken any of the following agents within 7 days prior to initiation of chemotherapy (the study): 5-HT3 receptor antagonists, phenothiazines, benzamides, domperidone, cannabinoids, or NK-1 receptor antagonist.
* Subject has taken any benzodiazepine within 1 day (24 hours) prior to initiation of chemotherapy (the study).
* Subject is scheduled to receive any other chemotherapeutic agent from Day 2 through Day 6.
* Subject is scheduled to receive any radiation therapy to the abdomen or pelvis from Day -5 through Day 6.
* Subject has received systemic corticosteroids or sedative antihistamines within 72 hours of Day 1 of the study, except as premedication for chemotherapy (e.g., taxanes, pemetrexed).
* Subject has symptomatic primary or metastatic central nervous system (CNS) disease.
* Subject has ongoing vomiting, retching, or nausea caused by any etiology, or has a history of anticipatory nausea and vomiting.
* Subject has vomited and/or has had dry heaves or retching within 24 hours prior to the start of HEC on Day 1.
* Subject is NOT able to swallow oral medications (pills) without difficulty.
C: Inclusion Criteria:

* Patient is greater than 18 years of age.
* Patient is scheduled to receive his/her first

course of cisplatin chemotherapy for a solid tumor.

* Patient has a prognosis (life expectancy) greater than or equal to 3 months.
D: 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 marrow, kidney, and liver function

Exclusion Criteria:

* Contraindication to cisplatin, granisetron, or dexamethasone
* Is pregnant or breast feeding
* Has previously received cisplatin or subject is planning to receive multiple days of cisplatin in a single cycle
* Has taken the following agents within the last 48 hours 5-HT3 antagonists,Phenothiazines,Benzamides,Domperidone,Cannabinoids,NK1 antagonist, Benzodiazepines
* Scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 4 or above (Hesketh Scale) from Day 2 through Day 6, except on Day 1.
* Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -5 through Day 6
* Has received systemic corticosteroids or sedative antihistamines within 72 hours of Day 1 of the study except as premedication for chemotherapy (e.g., taxanes, pemetrexed)
* Symptomatic primary or metastatic CNS disease.
* Has ongoing vomiting, retching, clinically significant nausea caused by any etiology, or has a history of anticipatory nausea and vomiting.
* Has vomited and/or has had dry heaves/retching within 24 hours prior to the start of cisplatin-based chemotherapy on Day 1 in Cycle 1.

Answer: B