Clinical trial NCT01053897: Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery
Official title: A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scar Formation
Keywords: GBT009
incisional scar
breast reconstruction
Lead sponsor: Garnet BioTherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-22
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess whether intradermal injections of GBT009 along full thickness incisions following surgery results in an improvement in scar appearance.


Eligibility criteria: Inclusion Criteria: Subjects must meet all of the following criteria to be considered eligible to participate in the study:

* be a female between 18 and 70 years of age, inclusive
* have a body mass index ≤ 32 kg/m2 and a body weight between 50 and 95 kg, inclusive
* be scheduled for a mastectomy with breast reconstruction surgery using an abdominal flap technique
* for women diagnosed with breast cancer, has standard of care treatment for breast cancer prior to surgery and will have standard of care treatment for breast cancer after surgery
* for subjects of childbearing potential, be surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA through completion of the study and have negative results on a serum pregnancy test done before administration of study medication (women who are postmenopausal \[no menses for at least 2 years\] are also eligible to participate)
* be able to understand the study procedures, agree to participate in the study program, and voluntarily provide written informed consent

Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from participating in the study:

* have clinically significant laboratory abnormalities at screening
* have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, coagulopathic disorder or other condition that would preclude participation in the study
* have received treatment for a severe, uncontrolled inflammatory disease or allergic condition within three months of screening
* have a life expectancy ≤ 2 years
* have a history of alcoholism or drug addiction or abuse within 5 years
* have evidence of a clinically significant abnormality upon evaluation of 12 lead ECG
* have evidence of any past or present clinically significant medical condition, including skin disease, that would impair wound healing
* have a history of keloid scar formation
* have existing scarring in the abdominal area of study that would interfere with the efficacy assessments
* have a history of (within the past 5 years) or an active malignancy, other than breast cancer
* have a breast cancer that has been staged at Stage IIIB, IIIC or IV
* have received a cytotoxic agent or have been treated with radiation within 90 days of screening and/or, in the opinion of the investigator, will likely require treatment in the 30 day period following the administration of study medication
* have received anticoagulation medication within 5 days of dosing with study medication
* have participated in any study involving an investigational product within 30 days before dosing with study medication
* have routinely used tobacco products within 6 months preceding the study period

Primary outcomes:
measure: Photography- Independent Scar Assessment Panel
timeFrame: 0.5, 1, 2, 3, 6, 9 and 12 Months
Secondary outcomes:
measure: Overall Scar Preference
timeFrame: 12 Month (End of Study)
measure: Patient Observer Scar Assessment Scale (POSAS)
timeFrame: 12 Month (End of Study)
measure: Manchester Scar Scale (MSS)
timeFrame: 12 Month (End of Study)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Garnet BioTherapeutics Investigational Site
state: Illinois
city: Rochester
country: United States
facility: Garnet BioTherapeutics Investigational Site
state: New York
Study officials:
affiliation: Garnet BioTherapeutics, Inc.
name: Garnet Study Manager
role: STUDY_DIRECTOR
References: