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

NCT01700140 | Completed Phase 2 Results

• 1 other identifier: 2010003
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 21

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.

Conditions

Radiotherapy-induced Nausea and Vomiting (RINV)

Outcome Measures

Primary Outcomes (1)

• 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

  The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.

  72 hours

Secondary Outcomes (8)

• 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

  72 hours

• Time to First Emesis

  24-72 hours

• Time to First Nausea

  24-72 hours

• Complete Control Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3

  24-72 hours

• Complete Response Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3

  24-72 hours

Study Arms (3)

SyB D-0701: high dose group

EXPERIMENTAL

Drug: SyB D-0701

SyB D-0701: low dose group

EXPERIMENTAL

Drug: SyB D-0701; Drug: Placebo

placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SyB D-0701 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: high dose group; SyB D-0701: low dose group

Placebo 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.

SyB D-0701: low dose group; placebo group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically verified malignant tumors
• Patients receiving radiotherapy alone who are scheduled for at least 3 fractions, each at a radiation dose of 1.5 to 3.0 Gy
• 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)
• 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
• Male patients who are surgically sterilized, or who agree to practice adequate contraception during the study
• Female patients of child-bearing potential who agree to practice adequate contraception during the study
• Patients whose performance status (PS) of Eastern Cooperative Oncology Group (ECOG) is 0 to 2
• Patients who were at least 20 years of age when their consent was obtained
• Patients who have given consent in writing to participate in the study with full understanding of the explanatory documents

You may not qualify if:

• 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.
• Patients with primary or metastasized brain tumors who show signs of elevated intracranial pressure
• 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)
• 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)
• Patients with abnormal findings (e.g., erythema, rash, wounds) at sites where the study drug has been applied
• Patients with a history of hypersensitivity to study drug ingredients or to other 5-HT3 receptor antagonists
• Patients with a history of allergy involving dermal symptoms
• Patients with clear signs of infection (including viral infection)
• Patients with complications from drug or alcohol dependence, or with a history of the same
• 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.
• Patients with serious hepatic or renal damage \[Grade 3 or above in the Common Terminology Criteria for Adverse Events (CTCAE) (ver. 4.0-JCOG)\]
• Patients with cardiac dysfunction
• Patients who are pregnant, who might be pregnant or who are currently lactating
• Other patients judged as unsuitable by the investigator or sub-investigators

Sponsors & Collaborators

• SymBio Pharmaceuticals: lead

Study Sites (21)

Research site

Nagoya, Aichi-ken, Japan

Location

Research site

Kashiwa, Chiba, Japan

Location

Research site

Matsuyama, Ehime, Japan

Location

Research site

Kurume, Fukuoka, Japan

Location

Research site

Maebashi, Gunma, Japan

Location

Research site

Ōta, Gunma, Japan

Location

Research site

Hiroshima, Hiroshima, Japan

Location

Research site

Sapporo, Hokkaido, Japan

Location

Research site

Sagamihara, Kanagawa, Japan

Location

Research site

Yokohama, Kanagawa, Japan

Location

Research

Kyoto, Kyoto, Japan

Location

Research site

Kashihara, Nara, Japan

Location

Research site

Niigata, Niigata, Japan

Location

Research site

Nakagami, Okinawa, Japan

Location

Research site

Sayama, Osaka, Japan

Location

Research site

Hidaka, Saitama, Japan

Location

Research site

Kitaadachi, Saitama, Japan

Location

Research Site

Koshigaya, Saitama, Japan

Location

Reseach site

Tokyo, Tokyo, Japan

Location

Research site

Tokyo, Tokyo, Japan

Location

Research site

Yamagata, Yamagata, Japan

Location

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nobuyuki Koseki
• Organization: SymBio Pharmaceuticals

+81-3-5472-1127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: October 4, 2012
• Study Start: May 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 19, 2014
• Results First Posted: November 19, 2014

Record last verified: 2014-11

Locations

JP (21)