Efficacy of SNX-1012 in the Treatment of Oral Mucositis

This study has been completed.
Sponsor:
Information provided by:
Mucosal Therapeutics
ClinicalTrials.gov Identifier:
NCT00385515
First received: October 5, 2006
Last updated: April 8, 2009
Last verified: April 2009
  Purpose

Oral mucositis (OM) is a common and debilitating toxicity induced by many chemotherapy (CT) regimens and by radiation to the head and neck. The purpose of this study is to determine the effectiveness of SNX-1012 in decreasing the duration of Grade 2, 3, or 4 oral mucositis (OM) according to World Health Organization (WHO) criteria.


Condition Intervention Phase
Stomatitis
Oral Mucositis
Drug: SNX-1012 (meclocycline sulfosalicylate)
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of SNX-1012 in Reducing the Duration and Severity of Ulcerative Oral Mucositis in Patients Receiving Cytotoxic Chemotherapy for Breast or Lung Cancer

Resource links provided by NLM:


Further study details as provided by Mucosal Therapeutics:

Primary Outcome Measures:
  • Duration of Ulcerative Oral Mucositis [ Time Frame: At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants With Ulcerative Oral Mucositis [ Time Frame: At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: June 2006
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
SNX-1012 (meclocyline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg 4 times daily for 10 days
Drug: SNX-1012 (meclocycline sulfosalicylate)
tablets to be dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
Placebo Comparator: 2
placebo (matched to SNX-1012) tablets dissolved in water for oral swish and expectorate; 4 times daily for 10 days
Drug: placebo
Tablets to be dissolved in water for oral swish and expectorate; placebo, 4 times daily for 10 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent
  • Naive to focal radiation therapy in the head and neck regions for cancer prior to CT Cycle 1. Subjects with prior or concomitant radiation therapy to areas other than the head and neck may be enrolled.
  • Histologically confirmed diagnosis of breast or lung cancer (NSCLC or SCLC)
  • Chemotherapy regimen containing AC ± T or EC ± T (for breast cancer), cisplatin or carboplatin (for NSCLC or SCLC), or doxorubicin (for SCLC)
  • Subjects will receive the same regimen and dose of CT in the OM Treatment CT Cycle as was administered in the immediately preceding CT Cycle.
  • Subjects will have had OM of WHO Grade of greater than or equal to 2 during CT Cycle 1 or Cycle 2
  • Subjects 18 years and older
  • Karnofsky Performance Score >=60
  • Baseline laboratory assessments:

Hemoglobin (Hgb) level >= 9 g/dL Absolute neutrophil count (ANC) >= 1.5 x 10 to the 9/L Platelet count >= 100 x 10 to the 9/L Serum bilirubin level <= 1.5 times institutional upper limit of normal (ULN) Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) level <= 2 times above ULN

  • Females of childbearing potential must have a negative serum or urine pregnancy test result at the screening visit prior to the start of Cycle 1 and at the visit scheduled for <= 48 hours prior to the start of the OM Treatment CT Cycle
  • Subjects with reproductive capability must agree to practice adequate contraception methods (males must use condoms or be surgically sterilized; females must be surgically sterilized, post-menopausal for at least 1 year, or use an appropriate double barrier method, prescribed birth control oral contraceptive, patch, implant, or injection during the course of the study and for up to 30 days after completion of study assessments)
  • Absence of other serious concurrent medical illness
  • Psychologically able to participate and comply with study requirements

Exclusion Criteria:

  • Prior history of oral mucositis with previous chemotherapy treatment
  • Previous treatment with an anthracycline agent (other than low-dose neoadjuvant therapy)
  • Active liver disease or serum AST and/or ALT level > 2 times above ULN
  • Currently receiving an investigational agent, planning to receive an investigational agent during the study period, or received an investigational agent within 30 days of the first dose of SNX-1012
  • Use of an immunosuppressive regimen of systemic corticosteroids
  • Unwilling/unable to receive periodic oral assessments by a study evaluator or unable to complete the daily self-reported outcome questionnaire
  • Pregnant or breast-feeding women
  • Bronchoalveolar carcinoma
  • Metastases to the central nervous system
  • Prior or planned focal radiation therapy in the head or neck regions for the treatment of cancer (prior radiation to areas other than the head and neck is permitted)
  • Presence of active or history of chronic oral mucosal disease
  • Presence or history of any other primary malignancy (curatively treated nonmelanoma skin cancer is allowed)
  • History of chronic liver disease
  • Active hepatitis A or B
  • Unable to receive CT during the OM Treatment CT Cycle at the same regimen and/or dose as in the immediately preceding CT cycle.
  • Known sensitivity to tetracyclines
  • Known to be seropositive for HIV or HCV
  • Use of an immunosuppressive regimen of systemic corticosteroids.
  • Current alcohol dependence or drug abuse
  • Psychological, social or familial or geographical reasons that would hinder or prevent study visits
  • Compromised ability to give written informed consent and/or to comply with study procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385515

Locations
United States, California
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States, 92270
United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut, United States, 06360
United States, Florida
Florida Research Cancer Institute
Davie, Florida, United States, 33328
United States, Minnesota
Park Nicollet Clinic
St Louis Park, Minnesota, United States, 55416
United States, Missouri
Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States, 65109
United States, Texas
Cancer Specialists of South Texas
Corpus Christi, Texas, United States, 78412
United States, Virginia
Cancer Outreach Associates
Abingdon, Virginia, United States, 24211
United States, West Virginia
Morgantown Internal Medicine Group
Morgantown, West Virginia, United States, 26505
India
Vedanta Institute of Medical Sciences
Navrangpura, Ahmedabad, Gujarat, India, 380009
Jawaharlal Nehru Cancer Hospital and Research Centre
Post Box No. 32, Idgah Hills, Bhopal, Madhya Pradesh, India, 462001
Apollo Speciality Hospital
320, Mount Road, Teynampet, Chennai, Tamil Nadu, India, 600035
Dharamshila Cancer Hospital and Research Centre,
Dharamshila Marg, Vasundhara Enclave, Dehli, India, 110096
Apollo Hospitals
Jubilee Hills, Hyderabad, Andhra Pradesh, India, 500033
Nizams Institute of Medical Sciences
Punjagutta, Hyderabad, Andhra Pradesh, India, 500082
Bhagwan Mahavir Cancer Hospital and Research Centre,
Jawaharlal Nehru Marg, Jaipur, Rajasthan, India, 302017
S.K Sony Hospital, Vidyadhar Nagar,
Sector-5 Sikar Road, Jaipur, Rajasthan, India, 302013
Netaji Subhash Chandra Bose Cancer Hospital & Research Institute
16A Park Lane, Kolkatta, West Bengal, India, 700016
Chittaranjan National Cancer Institute
37, S.P. Mukherjee Rd., Kolkatta, West Bengal, India, 700026
Dayanand Medical College & Hospital
Tagore Nagar, Civil Lines, Ludhiana, Punjab, India, 141001
Jaslok Hospital & Research Centre
15-Dr. G. Deshmukh Marg, Mumbai, Maharashtra, India, 400026
Jehangir Hospital,
32 Sassoon Road, Pune, Maharashtra, India, 411001
Ruby Hall Clinic,
40, Sassoon Road, Pune, Maharashtra, India, 411001
Seth Ramdas Shah Memorial Hospital & Research Centre
FP-402, Gokhle Nagar Road, Shivaji Nagar, Pune, Maharashtra, India, 411016
North Bengal Oncology Centre,
Pradhan Nagar, Siliguri, Dist- Darjeeling, West Bengal, India, 734003
Regional Cancer Centre
Medical College Campus, Post Bag No. 2417, Trivandrum, Kerala, India, 695011
Christian Medical College & Hospital
IDA Scuddar Road, Vellore, Tamil Nadu, India, 632004
Sponsors and Collaborators
Mucosal Therapeutics
  More Information

No publications provided

Responsible Party: Marna Doucette, Coserics
ClinicalTrials.gov Identifier: NCT00385515     History of Changes
Other Study ID Numbers: SNX-1012-CLN2-006
Study First Received: October 5, 2006
Results First Received: January 19, 2009
Last Updated: April 8, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stomatitis
Mucositis
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Meclocycline
Oxytetracycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014