EGFR Inhibitor-associated RashPhase 1NCT00656786
Safety, Tolerability and Systemic Absorption of Menadione Topical Lotion for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash
A Phase 1 study testing Menadione Topical Lotion in people with EGFR Inhibitor-associated Rash, run by Spectrum Pharmaceuticals, Inc at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Inhibitor-associated Rash
- What is being tested?
- Menadione Topical Lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 3 Apr 2008to 30 Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- For Group 2: Expect to start EGFRI therapy one day after starting treatment with study lotion;
- Have an Eastern Co-operative Oncology Group (ECOG) performance rating ≤ 2 (see Appendix 1);
- Have a life expectancy of at least 4 months;
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- 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);
- 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);
- Surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Documentation is required;
- Intrauterine device in place for at least 3 months;
- Double-barrier method (condom and diaphragm) with spermicide for at least 14 days prior to screening and through study completion;
- Stable hormonal contraceptive (oral, topical, vaginal or implanted//injected) for at least 3 months prior to study and through study completion;
- Abstinence;
- Single-barrier method for at least 14 days prior to screening and through study completion for vasectomized males or females with vasectomized partners;
- Able to understand and provide signed informed consent;
- 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).
Who cannot join
- Subjects who meet any of the following criteria are not eligible for enrollment.
- 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);
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- 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;
- Known hypersensitivity to menadione or similar compounds including any of the inactive ingredients;
- Treatment with oral anticoagulant therapy (i.e., Warfarin);
- Any subjects with prior history of bleeding and hematologic disorders;
- Clinically significant abnormal laboratory values at screening, to include but not limited to the following hematologic, renal and liver function laboratory values:
- 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)
- 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
- 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
- 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;
- Known or suspected pregnancy, lactation or planned pregnancy (females and males);
- Clinically significant mental illness (to be determined by the Investigator);
- 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);
- 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]);
- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Robert H. Lurie Cancer Center, Northwestern University
Chicago, Illinois, 60611
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Fox Chase Cancer Center
Rockledge, Pennsylvania, 19046
Washington University School of Medicine
St Louis, Missouri, 63110
Solano Clinical Research
Vallejo, California, 94589
About this study
Official title: 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
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:
Read more
- 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.
- Conditions
- EGFR Inhibitor-associated Rash
- Being tested
- Menadione Topical Lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menadione Topical LotionDrug
Menadione Lotion will be applied topically twice a day; beginning when the rash appears during EGFRi therapy.
Menadione Topical LotionDrug
Menadione Lotion will be applied topically twice a day, starting 1 day before EGFRi therapy.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Subjects will be treated if, after starting treatment with an EGFRi, acute signs and symptoms of rash on the face/neck and/or upper chest emerge, that are suspected of being related to the EGFRi treatment. Receives: Drug: Menadione Topical Lotion |
| Group 2 | Experimental | Subjects will receive pre-emergent rash treatment starting 1 day prior to beginning EGFRi therapy Receives: Drug: Menadione Topical Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety, tolerability and systemic absorption of Menadione Topical Lotion as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash
Measured: 6 weeks
Secondary outcomes (1)
To evaluate skin rash status as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study start3 Apr 2008
- Primary completion30 Dec 2009
- Study completion30 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Inhibitor-associated RashStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Colavincenzo, MD, Principal investigator, Robert H. Lurie Cancer Center, Northwestern UniversityVera Hirsh, MD, Principal investigator, McGill UniversityMilan Anadkat, MD, Principal investigator, Washington University School of MedicineSerena Mraz, MD, Principal investigator, Solano Clinical ResearchCliff Perlis, MD, Principal investigator, Fox Chase Cancer Center, Rockledge, PAMadeline Duvic, MD, Principal investigator, MD Anderson Cancer Center, Houston, TXJennifer Temel, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656786
- Sponsor's protocol ID
- HBS701
- Status last verified
- Nov 2020
- First submitted
- 7 Apr 2008
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00656786
- Acronym / sponsor ID
- HBS701
- Conditions
- EGFR Inhibitor-associated Rash
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2008 (actual)
- Primary completion
- 30 Dec 2009 (actual)
- Study completion
- 30 Dec 2009 (actual)
- First posted
- 11 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Menadione Topical LotionSubjects will be treated if, after starting treatment with an EGFRi, acute signs and symptoms of rash on the face/neck and/or upper chest emerge, that are suspected of being related to the EGFRi treatment. |
| Group 2 | Experimental | Drug: Menadione Topical LotionSubjects will receive pre-emergent rash treatment starting 1 day prior to beginning EGFRi therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
- For Group 2: Expect to start EGFRI therapy one day after starting treatment with study lotion;
- Have an Eastern Co-operative Oncology Group (ECOG) performance rating ≤ 2 (see Appendix 1);
Key exclusion criteria (28 listed)
- Subjects who meet any of the following criteria are not eligible for enrollment.
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menadione Topical LotionMenadione Lotion will be applied topically twice a day; beginning when the rash appears during EGFRi therapy. | Drug | Group 1 |
| Menadione Topical LotionMenadione Lotion will be applied topically twice a day, starting 1 day before EGFRi therapy. | Drug | Group 2 |
Primary outcome
To evaluate safety, tolerability and systemic absorption of Menadione Topical Lotion as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash
Time frame: 6 weeks
1 secondary outcome
To evaluate skin rash status as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Colavincenzo, MD principal investigator
Robert H. Lurie Cancer Center, Northwestern University
Vera Hirsh, MD principal investigator
McGill University
Milan Anadkat, MD principal investigator
Washington University School of Medicine
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Menadione Topical Lotion in people with EGFR Inhibitor-associated Rash, run by Spectrum Pharmaceuticals, Inc at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.