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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014