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

July 9, 2008
July 10, 2008
April 2007
September 2007   (final data collection date for primary outcome measure)
Investigator assessment of hair loss using a 10 point scale [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00713154 on ClinicalTrials.gov Archive Site
A time to event analysis of the hair loss [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Preliminary Efficacy Study of MTS-01 for the Prevention of Alopecia Induced by WHole Brain Radiotherapy
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

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

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Alopecia
  • Drug: MTS-01
    MTS-01 7% gel in 100 ml tubes, two 100 ml tubes prior to each radiation treatment
  • Drug: Placebo
    Placebo gel in 100 ml tube, two 100 ml tubes prior to each radiation treatment
  • Placebo Comparator: 1
    Placebo group
    Intervention: Drug: Placebo
  • Active Comparator: 2
    Control Group
    Intervention: Drug: MTS-01
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
September 2008
September 2007   (final data collection date for primary outcome measure)

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:

-

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00713154
Mito 02-02
No
Louis Habash/ President and CEO, Mitos Pharmaceuticals, Inc.
Mitos Pharmaceuticals
Not Provided
Not Provided
Mitos Pharmaceuticals
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP