Efficacy of SNX-1012 in the Treatment of Oral Mucositis

Phase 2

Completed

Conditions: Stomatitis
Oral Mucositis

Interventions: Drug: SNX-1012 (meclocycline sulfosalicylate)
Drug: placebo

Registration Number: NCT00385515

Lead Sponsor: Mucosal Therapeutics

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 81

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	SNX-1012 (meclocycline sulfosalicylate)	SNX-1012 (meclocyline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg 4 times daily for 10 days
2	placebo	placebo (matched to SNX-1012) tablets dissolved in water for oral swish and expectorate; 4 times daily for 10 days

Primary Outcome Measures

Name	Time	Method
Duration of Ulcerative Oral Mucositis	At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle	All randomized subjects were directly observed by trained evaluators for at least 10 consecutive days during the chemotherapy cycle to document the duration for those that developed recurrent ulcerative oral mucositis

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Ulcerative Oral Mucositis	At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle	All randomized subjects were directly observed by trained evaluators for at least 10 consecutive days during the chemotherapy cycle to identify recurrence of ulcerative oral mucositis.

Trial Locations

Locations (27): Florida Research Cancer Institute
🇺🇸
Davie, Florida, United States
Cancer Outreach Associates
🇺🇸
Abingdon, Virginia, United States
Capitol Comprehensive Cancer Care Clinic
🇺🇸
Jefferson City, Missouri, United States
Nizams Institute of Medical Sciences
🇮🇳
Punjagutta, Hyderabad, Andhra Pradesh, India
Park Nicollet Clinic
🇺🇸
St Louis Park, Minnesota, United States
Dayanand Medical College & Hospital
🇮🇳
Tagore Nagar, Civil Lines, Ludhiana, Punjab, India
Regional Cancer Centre
🇮🇳
Medical College Campus, Post Bag No. 2417, Trivandrum, Kerala, India
Apollo Hospitals
🇮🇳
Jubilee Hills, Hyderabad, Andhra Pradesh, India
S.K Sony Hospital, Vidyadhar Nagar,
🇮🇳
Sector-5 Sikar Road, Jaipur, Rajasthan, India
Jaslok Hospital & Research Centre
🇮🇳
15-Dr. G. Deshmukh Marg, Mumbai, Maharashtra, India
Ruby Hall Clinic,
🇮🇳
40, Sassoon Road, Pune, Maharashtra, India
Chittaranjan National Cancer Institute
🇮🇳
37, S.P. Mukherjee Rd., Kolkatta, West Bengal, India
Jehangir Hospital,
🇮🇳
32 Sassoon Road, Pune, Maharashtra, India
Seth Ramdas Shah Memorial Hospital & Research Centre
🇮🇳
FP-402, Gokhle Nagar Road, Shivaji Nagar, Pune, Maharashtra, India
Dharamshila Cancer Hospital and Research Centre,
🇮🇳
Dharamshila Marg, Vasundhara Enclave, Dehli, India
Netaji Subhash Chandra Bose Cancer Hospital & Research Institute
🇮🇳
16A Park Lane, Kolkatta, West Bengal, India
Christian Medical College & Hospital
🇮🇳
IDA Scuddar Road, Vellore, Tamil Nadu, India
Apollo Speciality Hospital
🇮🇳
320, Mount Road, Teynampet, Chennai, Tamil Nadu, India
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
Bhagwan Mahavir Cancer Hospital and Research Centre,
🇮🇳
Jawaharlal Nehru Marg, Jaipur, Rajasthan, India
North Bengal Oncology Centre,
🇮🇳
Pradhan Nagar, Siliguri, Dist- Darjeeling, West Bengal, India
Desert Hematology Oncology Medical Group
🇺🇸
Rancho Mirage, California, United States
Bridgeport Hospital
🇺🇸
Bridgeport, Connecticut, United States
Cancer Specialists of South Texas
🇺🇸
Corpus Christi, Texas, United States
Morgantown Internal Medicine Group
🇺🇸
Morgantown, West Virginia, United States
Eastern Connecticut Hematology & Oncology Associates
🇺🇸
Norwich, Connecticut, United States