NCT00385515

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2006

Geographic Reach
2 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
9 months until next milestone

Results Posted

Study results publicly available

March 18, 2009

Completed
Last Updated

May 7, 2009

Status Verified

April 1, 2009

Enrollment Period

1.9 years

First QC Date

October 5, 2006

Results QC Date

January 19, 2009

Last Update Submit

April 8, 2009

Conditions

StomatitisOral Mucositis

Outcome Measures

Primary Outcomes (1)

  • 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

    At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle

Secondary Outcomes (1)

  • Number of Participants With Ulcerative Oral Mucositis

    At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle

Study Arms (2)

1

EXPERIMENTAL

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

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

Drug: placebo

Interventions

SNX-1012 (meclocycline sulfosalicylate)DRUG

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

1
placeboDRUG

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Desert Hematology Oncology Medical Group

Rancho Mirage, California, 92270, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Eastern Connecticut Hematology & Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Florida Research Cancer Institute

Davie, Florida, 33328, United States

Location

Park Nicollet Clinic

Saint Louis Park, Minnesota, 55416, United States

Location

Capitol Comprehensive Cancer Care Clinic

Jefferson City, Missouri, 65109, United States

Location

Cancer Specialists of South Texas

Corpus Christi, Texas, 78412, United States

Location

Cancer Outreach Associates

Abingdon, Virginia, 24211, United States

Location

Morgantown Internal Medicine Group

Morgantown, West Virginia, 26505, United States

Location

Vedanta Institute of Medical Sciences

Navrangpura, Ahmedabad, Gujarat, 380009, India

Location

Jawaharlal Nehru Cancer Hospital and Research Centre

Post Box No. 32, Idgah Hills, Bhopal, Madhya Pradesh, 462001, India

Location

Apollo Speciality Hospital

320, Mount Road, Teynampet, Chennai, Tamil Nadu, 600035, India

Location

Dharamshila Cancer Hospital and Research Centre,

Dharamshila Marg, Vasundhara Enclave, Dehli, 110096, India

Location

Apollo Hospitals

Jubilee Hills, Hyderabad, Andhra Pradesh, 500033, India

Location

Nizams Institute of Medical Sciences

Punjagutta, Hyderabad, Andhra Pradesh, 500082, India

Location

Bhagwan Mahavir Cancer Hospital and Research Centre,

Jawaharlal Nehru Marg, Jaipur, Rajasthan, 302017, India

Location

S.K Sony Hospital, Vidyadhar Nagar,

Sector-5 Sikar Road, Jaipur, Rajasthan, 302013, India

Location

Netaji Subhash Chandra Bose Cancer Hospital & Research Institute

16A Park Lane, Kolkatta, West Bengal, 700016, India

Location

Chittaranjan National Cancer Institute

37, S.P. Mukherjee Rd., Kolkatta, West Bengal, 700026, India

Location

Dayanand Medical College & Hospital

Tagore Nagar, Civil Lines, Ludhiana, Punjab, 141001, India

Location

Jaslok Hospital & Research Centre

15-Dr. G. Deshmukh Marg, Mumbai, Maharashtra, 400026, India

Location

Jehangir Hospital,

32 Sassoon Road, Pune, Maharashtra, 411001, India

Location

Ruby Hall Clinic,

40, Sassoon Road, Pune, Maharashtra, 411001, India

Location

Seth Ramdas Shah Memorial Hospital & Research Centre

Fp-402, Gokhle Nagar Road, Shivaji Nagar, Pune, Maharashtra, 411016, India

Location

North Bengal Oncology Centre,

Pradhan Nagar, Siliguri, Dist- Darjeeling, West Bengal, 734003, India

Location

Regional Cancer Centre

Medical College Campus, Post Bag No. 2417, Trivandrum, Kerala, 695011, India

Location

Christian Medical College & Hospital

IDA Scuddar Road, Vellore, Tamil Nadu, 632004, India

Location

MeSH Terms

Conditions

Stomatitis

Interventions

meclocycline

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Eward G. Fey, PhD
Organization
Mucosal Therapeutics, LLC
857-228-1100

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 5, 2006

First Posted

October 9, 2006

Study Start

June 1, 2006

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

May 7, 2009

Results First Posted

March 18, 2009

Record last verified: 2009-04

Locations

IN(18)US(9)