Efficacy of SNX-1012 in the Treatment of Oral Mucositis

Oral Mucositis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385515
• Other study ID #: SNX-1012-CLN2-006
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2006
• Last updated: April 8, 2009
• Start date: June 2006
• Est. completion date: July 2008

Study information

• Verified date: April 2009
• Source: Mucosal Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Mucosal Therapeutics

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Ulcerative Oral Mucositis		At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle	No
Secondary	Number of Participants With Ulcerative Oral Mucositis		At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle	No