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

This study has been terminated.
(Major planned study protocol modifications)
Sponsor:
Information provided by:
Mitos Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00713154
First received: July 9, 2008
Last updated: July 10, 2008
Last verified: July 2008
  Purpose

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


Condition Intervention Phase
Alopecia
Drug: MTS-01
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Further study details as provided by Mitos Pharmaceuticals:

Primary Outcome Measures:
  • Investigator assessment of hair loss using a 10 point scale [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A time to event analysis of the hair loss [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: April 2007
Estimated Study Completion Date: September 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

-

  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Louis Habash/ President and CEO, Mitos Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00713154     History of Changes
Other Study ID Numbers: Mito 02-02
Study First Received: July 9, 2008
Last Updated: July 10, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Mitos Pharmaceuticals:
Radiotherapy
induced

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 16, 2014