Safety, Tolerability and Systemic Absorption of Menadione Topical Lotion for Epidermal-Growth-Fac… (NCT00656786) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability and Systemic Absorption of Menadione Topical Lotion for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash
United States, Canada18 participantsStarted 2008-04-03
Plain-language summary
This is a clinical research study of an experimental new medication, Menadione Topical Lotion (MTL). The study lotion is experimental and has not been approved for public use. Hana Biosciences, Inc., the company that is developing MTL, is the sponsor of this study. EGFR inhibitors are used to treat non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer, breast cancer and head and neck cancer. One of the side effects of EFGR inhibitors is skin toxicities including an acneform skin rash.
This study is a Phase 1 study. The main purposes of this study are:
* Evaluate the safety and tolerability of Menadione Topical Lotion as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash
* Evaluate the systemic absorption and bioavailability of Menadione Topical Lotion as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash
It is planned that up to 24 patients undergoing EGFR inhibitor therapy will take part in this study at multiple clinical centers.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female subjects at least 18 years old;
. 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);
. 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;
. Have an Eastern Co-operative Oncology Group (ECOG) performance rating ≤ 2 (see Appendix 1);
. Have a life expectancy of at least 4 months;
. 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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate safety, tolerability and systemic absorption of Menadione Topical Lotion as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash
. Females of childbearing potential males with female sexual partners of childbearing potential must agree to use one of the following acceptable birth control methods:
. Surgically sterile (hysterectomy or bilateral oophorectomy);
Exclusion criteria
. 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;
. 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;
. 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;
. 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;
. Prior treatment with any other marketed or investigational EGFRI therapy within the 3 months prior to screening (Visit 1);
. 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;
. Systemic use of steroids will be stopped at Visit 1 and not allowed during the course of the study;
. Treatment with vitamin K supplements or multivitamins containing any form of vitamin K should be stopped at Visit 1;