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

July 10, 2008 updated by: Mitos Pharmaceuticals

A Phase II, Double-Blind Placebo-Controlled, Parallel Group Study of the Safety and Preliminary Efficacy of MTS-01, for the Prevention of Alopecia Induced by Whole Brain Radiotherapy

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Placebo group
Drug: Placebo
Placebo gel in 100 ml tube, two 100 ml tubes prior to each radiation treatment
Active Comparator: 2
Control Group
Drug: MTS-01
MTS-01 7% gel in 100 ml tubes, two 100 ml tubes prior to each radiation treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Investigator assessment of hair loss using a 10 point scale
Time Frame: up to 12 weeks
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
A time to event analysis of the hair loss
Time Frame: up to 12 weeks
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitos Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

September 1, 2007

Study Completion (Anticipated)

September 1, 2008

Study Registration Dates

First Submitted

July 9, 2008

First Submitted That Met QC Criteria

July 10, 2008

First Posted (Estimate)

July 11, 2008

Study Record Updates

Last Update Posted (Estimate)

July 11, 2008

Last Update Submitted That Met QC Criteria

July 10, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mito 02-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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