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A Phase 1, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Safety, Tolerability, and Systemic Absorption of Menadione Topical Lotion as an Emergent and Pre-emergent Treatment for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash


Phase 1
18 Years
N/A
Open (Enrolling)
Both
EGFR Inhibitor-associated Rash

Thank you

Trial Information

A Phase 1, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Safety, Tolerability, and Systemic Absorption of Menadione Topical Lotion as an Emergent and Pre-emergent Treatment for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash


Inclusion Criteria:



1. Male or female subjects at least 18 years old;

2. Have been prescribed an approved EGFRI to treat cancer and expect to begin this
treatment within 14 days (i.e., any EGFRI that is approved for the treatment of
cancer at the time of subject enrollment);

3. For Group 1: Agree to return to clinic at Visit 3 or at first acute signs and
symptoms of rash (papular and/or pustular eruptions and/or nodules) on the face/neck
and/or upper chest that is suspected of being related to the EGFRI therapy within 21
days after starting EGFRI therapy;

For Group 2: Expect to start EGFRI therapy one day after starting treatment with
study lotion;

4. Have an Eastern Co-operative Oncology Group (ECOG) performance rating ≤ 2 (see
Appendix 1);

5. Have a life expectancy of at least 4 months;

6. Males or non pregnant, non-lactating females who are postmenopausal, naturally or
surgically sterile, or who agree to use effective contraceptive methods throughout
the course of the study. Postmenopausal is defined as at least 12 months natural
spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral
oophorectomy);

7. Females of childbearing potential males with female sexual partners of childbearing
potential must agree to use one of the following acceptable birth control methods:

1. Surgically sterile (hysterectomy or bilateral oophorectomy);

2. Surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior
to study initiation). Documentation is required;

3. Intrauterine device in place for at least 3 months;

4. Double-barrier method (condom and diaphragm) with spermicide for at least 14
days prior to screening and through study completion;

5. Stable hormonal contraceptive (oral, topical, vaginal or implanted//injected)
for at least 3 months prior to study and through study completion;

6. Abstinence;

7. Single-barrier method for at least 14 days prior to screening and through study
completion for vasectomized males or females with vasectomized partners;

8. Able to understand and provide signed informed consent;

9. Females of childbearing potential must have a negative serum β-human chorionic
gonadotropin (hCG) pregnancy test at Visit 1 and negative urine β-hCG pregnancy test
at Visit 3 (Group 1) or Visit 2 (Group 2).

Exclusion Criteria:

Subjects who meet any of the following criteria are not eligible for enrollment.

1. A skin examination reveals the presence of any active disease (e.g., eczema), tattoos
or other problems, such as open lesions, that could make the application site
unacceptable for study drug lotion application, located on the face/neck and/or upper
chest that, in the Investigator's opinion, could confound the evaluation of the rash;

2. Any clinically significant safety laboratory or diagnostic results that, in the
opinion of the Investigator, would place the subject at undue risk if the subject
were to participate in the study;

3. Any clinically significant finding or concurrent clinical illness in the physical
examination or medical history that, in the opinion of the Investigator, would place
the subject at undue risk if the subject were to participate in the study;

4. Undergoing any current treatment for cancer other than the prescribed EGFRI that in
the opinion of the Investigator, would place the subject at undue risk if the subject
were to participate in the study;

5. Prior treatment with any other marketed or investigational EGFRI therapy within the 3
months prior to screening (Visit 1);

6. Treatment with topical antibiotics, topical steroids, and other topical treatments on
the face/neck and upper chest within 14 days of first study lotion application;

7. Systemic use of steroids will be stopped at Visit 1 and not allowed during the course
of the study;

8. Treatment with vitamin K supplements or multivitamins containing any form of vitamin
K should be stopped at Visit 1;

9. Known hypersensitivity to menadione or similar compounds including any of the
inactive ingredients;

10. Treatment with oral anticoagulant therapy (i.e., Warfarin);

11. Any subjects with prior history of bleeding and hematologic disorders;

12. Clinically significant abnormal laboratory values at screening, to include but not
limited to the following hematologic, renal and liver function laboratory values:

1. Hematologic function:

- Hemoglobin < 9.0 gL/dL or < 10.0 g/dL for subjects receiving hematopoietic
growth factors, such as darbopoeitin alfa or epoetin alfa

- ANC < 1,500/mm3 (or < 1.5 ×109/L)

- Platelet count < 100,000/mm3 (or < 100 ×109/L)

2. Renal function:

• Serum creatinine > 1.5 mg/dL or < 133 umol/L (SI units) or calculated
estimated creatinine clearance < 60 ml/min/1.73 m2 based on Cockcroft and Gault
formula

3. Hepatic function:

- Aspartate transaminase (AST) or alanine transaminase (ALT) > 3 ×
institutional upper limit of normal (ULN) or > 5 × institutional ULN if
documented liver metastasis

- Total bilirubin > 2 × institutional ULN or > 5 × institutional ULN if
documented liver metastasis

13. Treatment with any cosmetic cream, make-up or products such as sun screen, oils,
powders, perfumes, lotions, ointments, etc. to the anticipated study lotion
application area within 3 days before treatment or during the treatment period;

14. Known or suspected pregnancy, lactation or planned pregnancy (females and males);

15. Clinically significant mental illness (to be determined by the Investigator);

16. Exposure to any investigational agent within 2 weeks or 3 half-lives prior to
randomization (Visit 3, Day 1 for Group 1 or Visit 2, Day 1 for Group 2);

17. The subject will be disqualified if they have a rash for longer than 5 days at a
grade of 3 or more prior to administration of first menadione dose (per CTCAE v3.0
terminology [see Appendix 2]);

18. Subject has a condition the Investigator believes would interfere with the ability to
provide informed consent or comply with study instructions, or that might confound
the interpretation of the study results or put the subject at undue risk.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To evaluate safety, tolerability and systemic absorption of Menadione Topical Lotion as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Maria Colavincenzo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Robert H. Lurie Cancer Center, Northwestern University

Authority:

United States: Food and Drug Administration

Study ID:

HBS701

NCT ID:

NCT00656786

Start Date:

April 2008

Completion Date:

December 2013

Related Keywords:

  • EGFR Inhibitor-associated Rash
  • Exanthema

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Massachusetts General HospitalBoston, Massachusetts  02114-2617
The University of Texas, MD Anderson Cancer CenterHouston, Texas  77030
Solano Clinical ResearchVallejo, California  94589
Robert H. Lurie Cancer Center, Northwestern UniversityChicago, Illinois