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

This study is currently recruiting participants.
Verified October 2012 by SymBio Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
SymBio Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01700140
First received: September 11, 2012
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Radiotherapy-induced Nausea and Vomiting (RINV)
Drug: SyB D-0701
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Phase II Clinical Study of SyB D-0701 for Radiotherapy Induced Nausea and Vomiting

Resource links provided by NLM:


Further study details as provided by SymBio Pharmaceuticals:

Primary Outcome Measures:
  • Complete control (no emesis, no rescue-medication and no/mild nausea) rate from the start of radiotherapy until 24 hours after the third irradiation [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete response(no emesis, no rescue-medication) rate from the start of radiotherapy until 24 hours after the third irradiation [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Time to first emesis [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Time to first nausea [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Complete control rate and complete response rate within 24 hours after each irradiation from sessions 1 to 3 [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Up to 192 hours ] [ Designated as safety issue: Yes ]
  • Dermal findings at sites where drug patch was applied [ Time Frame: Up to 192 hours ] [ Designated as safety issue: Yes ]
  • Laboratory Tests (Hematology) [ Time Frame: Up to 168 hours ] [ Designated as safety issue: No ]
  • Laboratory Tests (Blood chemistry) [ Time Frame: Up to 168 hours ] [ Designated as safety issue: No ]
  • Laboratory Tests (Urinalysis) [ Time Frame: Up to 168 hours ] [ Designated as safety issue: No ]

Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SyB D-0701: high dose group Drug: 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] obtained 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.
Experimental: SyB D-0701: low dose group Drug: 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] obtained 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.
Drug: Placebo
Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) obtained 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 Comparator: placebo group Drug: Placebo
Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) obtained 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.

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700140

Contacts
Contact: Yumiko Yano +81-3-5472-1127 yyano.yy04@symbiopharma.com

Locations
Japan
Research site Recruiting
Nagoya, Aichi, Japan
Research site Recruiting
Kashiwa, Chiba, Japan
Research site Completed
Matsuyama, Ehime, Japan
Research site Completed
Kurume, Fukuoka, Japan
Research site Recruiting
Maebashi, Gunma, Japan
Research site Recruiting
Ota, Gunma, Japan
Research site Recruiting
Sapporo, Hokkaido, Japan
Research site Terminated
Sapporo, Hokkaido, Japan
Research site Recruiting
Sagamihara, Kanagawa, Japan
Research site Recruiting
Yokohama, Kanagawa, Japan
Research site Recruiting
Kashihara, Nara, Japan
Research site Recruiting
Nakagami, Okinawa, Japan
Research site Recruiting
Sayama, Osaka, Japan
Research site Recruiting
Hidaka, Saitama, Japan
Research site Completed
Kitaadachi, Saitama, Japan
Research Site Recruiting
Koshigaya, Saitama, Japan
Research site Completed
Hiroshima, Japan
Research Recruiting
Kyoto, Japan
Research site Recruiting
Niigata, Japan
Research site Recruiting
Tokyo, Japan
Reseach site Recruiting
Tokyo, Japan
Research site Completed
Tokyo, Japan
Reseach site Completed
Tokyo, Japan
Research site Recruiting
Yamagata, Japan
Sponsors and Collaborators
SymBio Pharmaceuticals
  More Information

No publications provided

Responsible Party: SymBio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01700140     History of Changes
Other Study ID Numbers: 2010003
Study First Received: September 11, 2012
Last Updated: October 4, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014