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

Primary Purpose

Alopecia

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MTS-01
Placebo
Sponsored by
Mitos Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alopecia focused on measuring Radiotherapy, induced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Placebo group

    Control Group

    Outcomes

    Primary Outcome Measures

    Investigator assessment of hair loss using a 10 point scale

    Secondary Outcome Measures

    A time to event analysis of the hair loss

    Full Information

    First Posted
    July 9, 2008
    Last Updated
    July 10, 2008
    Sponsor
    Mitos Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00713154
    Brief Title
    Safety and Preliminary Efficacy Study of MTS-01 for the Prevention of Alopecia Induced by WHole Brain Radiotherapy
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2008
    Overall Recruitment Status
    Terminated
    Why Stopped
    Major planned study protocol modifications
    Study Start Date
    April 2007 (undefined)
    Primary Completion Date
    September 2007 (Actual)
    Study Completion Date
    September 2008 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mitos Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alopecia
    Keywords
    Radiotherapy, induced

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo group
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Control Group
    Intervention Type
    Drug
    Intervention Name(s)
    MTS-01
    Intervention Description
    MTS-01 7% gel in 100 ml tubes, two 100 ml tubes prior to each radiation treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo gel in 100 ml tube, two 100 ml tubes prior to each radiation treatment
    Primary Outcome Measure Information:
    Title
    Investigator assessment of hair loss using a 10 point scale
    Time Frame
    up to 12 weeks
    Secondary Outcome Measure Information:
    Title
    A time to event analysis of the hair loss
    Time Frame
    up to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: -

    12. IPD Sharing Statement

    Learn more about this trial

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

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