Study to Assess Safety and Tolerability of AG013 in Oral Mucositis in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

September 30, 2012

Study Completion Date

September 30, 2012

Conditions
Oral Mucositis
Interventions
BIOLOGICAL

AG013

Mouth rinse once a day for 14 days

BIOLOGICAL

AG013

Mouth rinse three times a day for 14 days

BIOLOGICAL

AG013

Mouth rinse six times a day for 14 days

OTHER

Placebo

Mouth rinse once a day for 14 days

OTHER

Placebo

Mouth rinse three times a day for 14 days

OTHER

Placebo

Mouth rinse six times a day for 14 days

Trial Locations (6)

10003

Beth Israel Medical Center, New York

28203

Carolinas Medical Center, Charlotte

37232

Vanderbilt Ingram Cancer Center, Nashville

60612

University of Illinois at Chicago, Chicago

94305

Stanford University, Stanford

02115

Dana Farber Cancer Institute, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ActoGeniX N.V.

INDUSTRY

NCT00938080 - Study to Assess Safety and Tolerability of AG013 in Oral Mucositis in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck | Biotech Hunter | Biotech Hunter