Efficacy of SNX-1012 in the Treatment of Oral Mucositis

NCT ID: NCT00385515

Last Updated: 2009-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-07-31

Brief Summary

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.

Conditions

Stomatitis; Oral Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

SNX-1012 (meclocyline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg 4 times daily for 10 days

Group Type: EXPERIMENTAL

SNX-1012 (meclocycline sulfosalicylate)

Intervention Type: DRUG

tablets to be dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days

2

placebo (matched to SNX-1012) tablets dissolved in water for oral swish and expectorate; 4 times daily for 10 days

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Tablets to be dissolved in water for oral swish and expectorate; placebo, 4 times daily for 10 days

Interventions

SNX-1012 (meclocycline sulfosalicylate)

tablets to be dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days

Intervention Type: DRUG

placebo

Tablets to be dissolved in water for oral swish and expectorate; placebo, 4 times daily for 10 days

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mucosal Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Coserics

Locations

Desert Hematology Oncology Medical Group

Rancho Mirage, California, United States

Bridgeport Hospital

Bridgeport, Connecticut, United States

Eastern Connecticut Hematology & Oncology Associates

Norwich, Connecticut, United States

Florida Research Cancer Institute

Davie, Florida, United States

Park Nicollet Clinic

Saint Louis Park, Minnesota, United States

Capitol Comprehensive Cancer Care Clinic

Jefferson City, Missouri, United States

Cancer Specialists of South Texas

Corpus Christi, Texas, United States

Cancer Outreach Associates

Abingdon, Virginia, United States

Morgantown Internal Medicine Group

Morgantown, West Virginia, United States

Vedanta Institute of Medical Sciences

Navrangpura, Ahmedabad, Gujarat, India

Jawaharlal Nehru Cancer Hospital and Research Centre

Post Box No. 32, Idgah Hills, Bhopal, Madhya Pradesh, India

Apollo Speciality Hospital

320, Mount Road, Teynampet, Chennai, Tamil Nadu, India

Dharamshila Cancer Hospital and Research Centre,

Dharamshila Marg, Vasundhara Enclave, Dehli, India

Apollo Hospitals

Jubilee Hills, Hyderabad, Andhra Pradesh, India

Nizams Institute of Medical Sciences

Punjagutta, Hyderabad, Andhra Pradesh, India

Bhagwan Mahavir Cancer Hospital and Research Centre,

Jawaharlal Nehru Marg, Jaipur, Rajasthan, India

S.K Sony Hospital, Vidyadhar Nagar,

Sector-5 Sikar Road, Jaipur, Rajasthan, India

Netaji Subhash Chandra Bose Cancer Hospital & Research Institute

16A Park Lane, Kolkatta, West Bengal, India

Chittaranjan National Cancer Institute

37, S.P. Mukherjee Rd., Kolkatta, West Bengal, India

Dayanand Medical College & Hospital

Tagore Nagar, Civil Lines, Ludhiana, Punjab, India

Jaslok Hospital & Research Centre

15-Dr. G. Deshmukh Marg, Mumbai, Maharashtra, India

Jehangir Hospital,

32 Sassoon Road, Pune, Maharashtra, India

Ruby Hall Clinic,

40, Sassoon Road, Pune, Maharashtra, India

Seth Ramdas Shah Memorial Hospital & Research Centre

Fp-402, Gokhle Nagar Road, Shivaji Nagar, Pune, Maharashtra, India

North Bengal Oncology Centre,

Pradhan Nagar, Siliguri, Dist- Darjeeling, West Bengal, India

Regional Cancer Centre

Medical College Campus, Post Bag No. 2417, Trivandrum, Kerala, India

Christian Medical College & Hospital

IDA Scuddar Road, Vellore, Tamil Nadu, India

Countries

United States; India

Other Identifiers

SNX-1012-CLN2-006

Identifier Type: -

Identifier Source: org_study_id