Safety and Preliminary Efficacy Study of MTS-01 for the Prevention of Alopecia Induced by WHole Brain Radiotherapy

Phase 2

Terminated

• Conditions: Alopecia
• Interventions: Drug: Placebo; Drug: MTS-01

• Registration Number: NCT00713154
• Lead Sponsor: Mitos Pharmaceuticals

Brief Summary

The purpose of this study is to determine if MTS-01 is effective in preventing radiotherapy-induced hair loss in patients receiving whole brain radiotherapy

Detailed Description

Hair loss (alopecia) occurs commonly as a result of external beam radiotherapy to the brain, and contributes to the social isolation and distress of patients with cancer. MTS-01 is a topical gel formulation that can be applied to the scalp during delivery of radiotherapy

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2007-09
• Status Verified: 2008-07
• Study First Submitted: 2008-07-09
• Study First Submitted QC: 2008-07-10
• Last Update Submitted: 2008-07-10
• Study First Posted: 2008-07-11
• Last Update Posted: 2008-07-11
• Study Completion: 2008-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• is >/= 18 years of age
• Has metastatic cancer to the brain for which palliative or prophylactic whole brain radiotherapy is recommended. A histological diagnosis of cancer will be required, however, a biopsy of the brain metastases will not be required
• Can understand and sign the IRB/IEC approved informed consent, can communicate with the Investigator, and can understand with the requirements of the protocol
• has signed the HIPAA authorization

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo group
2	MTS-01	Control Group

Primary Outcome Measures

Name	Time	Method
Investigator assessment of hair loss using a 10 point scale	up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
A time to event analysis of the hair loss	up to 12 weeks