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
Overview
- Phase
- Phase 2
- Intervention
- SNX-1012 (meclocycline sulfosalicylate)
- Conditions
- Stomatitis
- Sponsor
- Mucosal Therapeutics
- Enrollment
- 81
- Locations
- 27
- Primary Endpoint
- Duration of Ulcerative Oral Mucositis
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
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
- •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:
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)
Arms & Interventions
1
SNX-1012 (meclocyline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg 4 times daily for 10 days
Intervention: SNX-1012 (meclocycline sulfosalicylate)
2
placebo (matched to SNX-1012) tablets dissolved in water for oral swish and expectorate; 4 times daily for 10 days
Intervention: placebo
Outcomes
Primary Outcomes
Duration of Ulcerative Oral Mucositis
Time Frame: 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 Outcomes
- Number of Participants With Ulcerative Oral Mucositis(At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle)