Phase II Study of SyB D-0701 for Radiotherapy-Induced Nausea and Vomiting (RINV)

Phase II Clinical Study of SyB D-0701 for Radiotherapy Induced Nausea and Vomiting

The purpose of this study is to explore the dose response of SyB D-0701 for preventing nausea and emesis associated with radiotherapy (fractionated/localized irradiation) in cancer patients scheduled to receive radiotherapy (fractionated/localized irradiation) alone.

Exploratory study of dose response of SyB D-0701 to preventing effects for nausea and emesis associated with radiotherapy (fractionated/localized irradiation)

Inclusion Criteria Patients must satisfy the following conditions listed below.

1. Patients with histologically verified malignant tumors
2. Patients receiving radiotherapy alone who are scheduled for at least 3 fractions, each at a radiation dose of 1.5 to 3.0 Gy
3. Cancer patients scheduled for radiotherapy over a field of at least 100 cm2 (50 cm2 or more in cases of irradiation of the vertebrae only) that includes the abdomen and pelvis (region with upper edge at the 11th thoracic vertebrae and lower edge at pelvic cavity)
4. Patients not scheduled to receive anti-tumor agents between the first and the fifth day of radiotherapy. If the patient has a history of anti-tumor agent therapy, however, at the time of the patient's registration, at least 5 days must have elapsed since drug administration was terminated, and the patient must not be scheduled to receive any anti-tumor agent from the first to the fifth day of radiotherapy
5. Male patients who are surgically sterilized, or who agree to practice adequate contraception during the study
6. Female patients of child-bearing potential who agree to practice adequate contraception during the study
7. Patients whose performance status (PS) of Eastern Cooperative Oncology Group (ECOG) is 0 to 2
8. Patients who were at least 20 years of age when their consent was obtained
9. Patients who have given consent in writing to participate in the study with full understanding of the explanatory documents

Exclusion Criteria Patients who satisfy any of the following conditions will not be enrolled in the study.

1. Patients with nausea and/or emesis; patients who also have intestinal obstruction, vestibular dysfunction (e.g., epilepsy), Meniere's syndrome, cerebral metastasis, electrolyte imbalance (hypercalcemia, hyperglycemia, hyponatremia), uremia, etc., and patients for whom it is judged that there is a high probability that their nausea or emesis arises from the aforementioned causes. Registration is possible, however, for patients with motion sickness (vehicle sickness) or patients with temporary nausea/emesis arising from routine activities.
2. Patients with primary or metastasized brain tumors who show signs of elevated intracranial pressure
3. Patients who previously received radiotherapy to the brain or to the region that includes the abdomen and pelvis (region with upper edge at the 11th thoracic vertebrae and lower edge at pelvic cavity)
4. Patients who take drugs that affect the evaluation of nausea or emesis (rescue medication and 5-hydroxytryptamine 3 (5-HT3) receptor antagonists, neurokinin 1 (NK1) receptor antagonists, anxiolytics, psychotropic drug, opioid analgesics and corticosteroid [systemic administration] except for rescue medication)
5. Patients with abnormal findings (e.g., erythema, rash, wounds) at sites where the study drug has been applied
6. Patients with a history of hypersensitivity to study drug ingredients or to other 5-HT3 receptor antagonists
7. Patients with a history of allergy involving dermal symptoms
8. Patients with clear signs of infection (including viral infection)
9. Patients with complications from drug or alcohol dependence, or with a history of the same
10. Patients who have participated in some type of clinical study (including physician-initiated clinical studies or clinical research) within 3 months prior to their registration for the present study and who have been given a study drug (including drugs not yet approved). Patients can be registered for this study, however, if they have participated in a clinical study, etc., in which only drugs already approved have been used.
11. Patients with serious hepatic or renal damage [Grade 3 or above in the Common Terminology Criteria for Adverse Events (CTCAE) (ver. 4.0-JCOG)]
12. Patients with cardiac dysfunction
13. Patients who are pregnant, who might be pregnant or who are currently lactating
14. Other patients judged as unsuitable by the investigator or sub-investigators