StomatitisPhase 2NCT00385515
Efficacy of SNX-1012 in the Treatment of Oral Mucositis
A Phase 2 study testing SNX-1012 (meclocycline sulfosalicylate) in people with Stomatitis and Oral Mucositis, run by Mucosal Therapeutics at 27 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomatitis, Oral Mucositis
- What is being tested?
- SNX-1012 (meclocycline sulfosalicylate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 27 sitesin 2 countries
- Study dates
- Jun 2006to Jul 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
India18 sites
Jaslok Hospital & Research Centre
15-Dr. G. Deshmukh Marg, Mumbai, Maharashtra, 400026
Netaji Subhash Chandra Bose Cancer Hospital & Research Institute
16A Park Lane, Kolkatta, West Bengal, 700016
Jehangir Hospital,
32 Sassoon Road, Pune, Maharashtra, 411001
Apollo Speciality Hospital
320, Mount Road, Teynampet, Chennai, Tamil Nadu, 600035
Chittaranjan National Cancer Institute
37, S.P. Mukherjee Rd., Kolkatta, West Bengal, 700026
Ruby Hall Clinic,
40, Sassoon Road, Pune, Maharashtra, 411001
Dharamshila Cancer Hospital and Research Centre,
Dharamshila Marg, Vasundhara Enclave, National Capital Territory of Delhi, 110096
Seth Ramdas Shah Memorial Hospital & Research Centre
Fp-402, Gokhle Nagar Road, Shivaji Nagar, Pune, Maharashtra, 411016
Christian Medical College & Hospital
IDA Scuddar Road, Vellore, Tamil Nadu, 632004
Bhagwan Mahavir Cancer Hospital and Research Centre,
Jawaharlal Nehru Marg, Jaipur, Rajasthan, 302017
Apollo Hospitals
Jubilee Hills, Hyderabad, Andhra Pradesh, 500033
Regional Cancer Centre
Medical College Campus, Post Bag No. 2417, Trivandrum, Kerala, 695011
Vedanta Institute of Medical Sciences
Navrangpura, Ahmedabad, Gujarat, 380009
Jawaharlal Nehru Cancer Hospital and Research Centre
Post Box No. 32, Idgah Hills, Bhopal, Madhya Pradesh, 462001
North Bengal Oncology Centre,
Pradhan Nagar, Siliguri, Dist- Darjeeling, West Bengal, 734003
Nizams Institute of Medical Sciences
Punjagutta, Hyderabad, Andhra Pradesh, 500082
S.K Sony Hospital, Vidyadhar Nagar,
Sector-5 Sikar Road, Jaipur, Rajasthan, 302013
Dayanand Medical College & Hospital
Tagore Nagar, Civil Lines, Ludhiana, Punjab, 141001
United States9 sites
Cancer Outreach Associates
Abingdon, Virginia, 24211
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Cancer Specialists of South Texas
Corpus Christi, Texas, 78412
Florida Research Cancer Institute
Davie, Florida, 33328
Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri, 65109
Morgantown Internal Medicine Group
Morgantown, West Virginia, 26505
Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut, 06360
Desert Hematology Oncology Medical Group
Rancho Mirage, California, 92270
Park Nicollet Clinic
Saint Louis Park, Minnesota, 55416
About this study
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
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
- Being tested
- SNX-1012 (meclocycline sulfosalicylate), placebo
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNX-1012 (meclocycline sulfosalicylate)Drug
tablets to be dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
placeboDrug
Tablets to be dissolved in water for oral swish and expectorate; placebo, 4 times daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SNX-1012 (meclocyline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg 4 times daily for 10 days Receives: Drug: SNX-1012 (meclocycline sulfosalicylate) |
| 2 | Placebo comparator | placebo (matched to SNX-1012) tablets dissolved in water for oral swish and expectorate; 4 times daily for 10 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Ulcerative Oral Mucositis
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
Measured: At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle
Secondary outcomes (1)
Number of Participants With Ulcerative Oral Mucositis
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.
Measured: At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2006 (estimated)
- Study startJun 2006
- Primary completionMay 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mucosal Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385515
- Sponsor's protocol ID
- SNX-1012-CLN2-006
- Status last verified
- Apr 2009
- First submitted
- 5 Oct 2006
- Last updated
- 7 May 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00385515
- Acronym / sponsor ID
- SNX-1012-CLN2-006
- Conditions
- Stomatitis, Oral Mucositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Mucosal TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 9 Oct 2006 (estimated)
- Results
- Posted 18 Mar 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 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 comparator | Drug: placeboplacebo (matched to SNX-1012) tablets dissolved in water for oral swish and expectorate; 4 times daily for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNX-1012 (meclocycline sulfosalicylate)tablets to be dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days | Drug | 1 |
| placeboTablets to be dissolved in water for oral swish and expectorate; placebo, 4 times daily for 10 days | Drug | 2 |
Primary outcome
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
1 secondary outcome
Number of Participants With Ulcerative Oral Mucositis
Time frame: At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Stomatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SNX-1012 (meclocycline sulfosalicylate) in people with Stomatitis and Oral Mucositis, run by Mucosal Therapeutics at 27 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in India, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Ulcerative Oral Mucositis (time frame: At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2009.