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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SymBio Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01700140
First received: September 11, 2012
Last updated: November 11, 2014
Last verified: November 2014
  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 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 [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.

  • Time to First Emesis [ Time Frame: 24-72 hours ] [ Designated as safety issue: No ]
    Time from the start of radiotherapy to the onset of first emesis. The median (50% point) of time to first emesis was estimated.

  • Time to First Nausea [ Time Frame: 24-72 hours ] [ Designated as safety issue: No ]
    Time from the start of radiotherapy to the onset of first nausea. The median (50% point) of time to first nausea was estimated.

  • Complete Control Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3 [ Time Frame: 24-72 hours ] [ Designated as safety issue: No ]

    Complete control rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.

    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.


  • Complete Response Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3 [ Time Frame: 24-72 hours ] [ Designated as safety issue: No ]

    Complete response rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.

    The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs.


  • Adverse Events [ Time Frame: Up to 192 hours ] [ Designated as safety issue: Yes ]
    Adverse event is any untoward medical occurrence experienced by a subject irrespective of causal relationship with the study drug, and includes the unexpected signs, clinically significant fluctuations of laboratory data, and aggravation of disease, symptoms or complications. Adverse events are coded using the preferred terms (PT) of Medical Dictionary for Regulatory Activities (MedDRA) version 15.0.

  • Severe (Grade 3 or More) Adverse Events [ Time Frame: Up to 192 hours ] [ Designated as safety issue: No ]

    The severity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

    Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE


  • Skin Manifestations at Study Drug Application Site [ Time Frame: Up to 192 hours ] [ Designated as safety issue: Yes ]

    The investigator or sub-investigator recorded skin manifestations observed after removal of the study drug.

    Skin manifestations were counted for each type of patches (placebo patch, SyB D-0701 15 cm2 patch, SyB D-0701 25 cm2 patch).



Enrollment: 189
Study Start Date: May 2011
Study Completion Date: October 2012
Primary Completion Date: October 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] 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.
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] 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.
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.
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) 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.

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700140

Locations
Japan
Research site
Nagoya, Aichi, Japan
Research site
Kashiwa, Chiba, Japan
Research site
Matsuyama, Ehime, Japan
Research site
Kurume, Fukuoka, Japan
Research site
Maebashi, Gunma, Japan
Research site
Ota, Gunma, Japan
Research site
Sapporo, Hokkaido, Japan
Research site
Sagamihara, Kanagawa, Japan
Research site
Yokohama, Kanagawa, Japan
Research site
Kashihara, Nara, 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
Research site
Hiroshima, Japan
Research
Kyoto, Japan
Research site
Niigata, Japan
Reseach site
Tokyo, Japan
Research site
Tokyo, Japan
Research site
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
Results First Received: October 1, 2014
Last Updated: November 11, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on May 29, 2015