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

NCT ID: NCT01700140

Last Updated: 2014-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-10-31

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)

Conditions

Radiotherapy-induced Nausea and Vomiting (RINV)

Study Design

• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

SyB D-0701: high dose group

Group Type: EXPERIMENTAL

SyB D-0701

Intervention Type: DRUG

Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch, High dose group (30.00 mg): SyB D-0701 15 cm2 patch + SyB D-0701 25 cm2 patch\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.

SyB D-0701: low dose group

Group Type: EXPERIMENTAL

SyB D-0701

Intervention Type: DRUG

Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch, High dose group (30.00 mg): SyB D-0701 15 cm2 patch + SyB D-0701 25 cm2 patch\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.

Placebo

Intervention Type: DRUG

Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.

placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.

Interventions

SyB D-0701

Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch, High dose group (30.00 mg): SyB D-0701 15 cm2 patch + SyB D-0701 25 cm2 patch\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.

Intervention Type: DRUG

Placebo

Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SymBio Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research site

Nagoya, Aichi-ken, Japan

Research site

Kashiwa, Chiba, Japan

Research site

Matsuyama, Ehime, Japan

Research site

Kurume, Fukuoka, Japan

Research site

Maebashi, Gunma, Japan

Research site

Ōta, Gunma, Japan

Research site

Hiroshima, Hiroshima, Japan

Research site

Sapporo, Hokkaido, Japan

Research site

Sagamihara, Kanagawa, Japan

Research site

Yokohama, Kanagawa, Japan

Research

Kyoto, Kyoto, Japan

Research site

Kashihara, Nara, Japan

Research site

Niigata, Niigata, Japan

Research site

Nakagami, Okinawa, Japan

Research site

Sayama, Osaka, Japan

Research site

Hidaka, Saitama, Japan

Research site

Kitaadachi, Saitama, Japan

Research Site

Koshigaya, Saitama, Japan

Reseach site

Tokyo, Tokyo, Japan

Research site

Tokyo, Tokyo, Japan

Research site

Yamagata, Yamagata, Japan

Countries

Japan

Other Identifiers

2010003

Identifier Type: -

Identifier Source: org_study_id