Clinical trial NCT01700140: Phase II Study of SyB D-0701 for Radiotherapy-Induced Nausea and Vomiting (RINV)
Official title: Phase II Clinical Study of SyB D-0701 for Radiotherapy Induced Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Radiotherapy-induced Nausea and Vomiting (RINV)
Lead sponsor: SymBio Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-10-04
Enrollment: 189
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL

Brief summary: 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.

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

Eligibility 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 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

Primary outcomes:
measure: Complete Control (no Signs of Emesis or Moderate to Severe Nausea and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation
timeFrame: 72 hours
Secondary outcomes:
measure: Complete Response (no Signs of Emesis and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation
timeFrame: 72 hours
measure: Time to First Emesis
timeFrame: 24-72 hours
measure: Time to First Nausea
timeFrame: 24-72 hours
measure: Complete Control Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3
timeFrame: 24-72 hours
measure: Complete Response Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3
timeFrame: 24-72 hours
measure: Adverse Events
timeFrame: Up to 192 hours
measure: Severe (Grade 3 or More) Adverse Events
timeFrame: Up to 192 hours
measure: Skin Manifestations at Study Drug Application Site
timeFrame: Up to 192 hours
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Research site
state: Aichi
city: Kashiwa
country: Japan
facility: Research site
state: Chiba
city: Matsuyama
country: Japan
facility: Research site
state: Ehime
city: Kurume
country: Japan
facility: Research site
state: Fukuoka
city: Maebashi
country: Japan
facility: Research site
state: Gunma
city: Ota
country: Japan
facility: Research site
state: Gunma
city: Sapporo
country: Japan
facility: Research site
state: Hokkaido
city: Sagamihara
country: Japan
facility: Research site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research site
state: Kanagawa
city: Kashihara
country: Japan
facility: Research site
state: Nara
city: Nakagami
country: Japan
facility: Research site
state: Okinawa
city: Sayama
country: Japan
facility: Research site
state: Osaka
city: Hidaka
country: Japan
facility: Research site
state: Saitama
city: Kitaadachi
country: Japan
facility: Research site
state: Saitama
city: Koshigaya
country: Japan
facility: Research Site
state: Saitama
city: Hiroshima
country: Japan
facility: Research site
city: Kyoto
country: Japan
facility: Research
city: Niigata
country: Japan
facility: Research site
city: Tokyo
country: Japan
facility: Reseach site
city: Tokyo
country: Japan
facility: Research site
city: Yamagata
country: Japan
facility: Research site
Study officials:
References: