Phase II Clinical Study of SyB D-0701 for Radiotherapy Induced Nausea and Vomiting
Inclusion Criteria
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 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-HT3 receptor antagonists, 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 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