Rash Due to Epidermal Growth Factor Receptor InhibitorsPhase 2NCT02239731
Safety, Tolerability and Efficacy Study of Doxycycline Foam for the Prevention of EGFRI Skin Toxicity in Cancer Patients
A Phase 2 study testing FDX104 (4% Doxycycline) in people with Rash Due to Epidermal Growth Factor Receptor Inhibitors, run by Vyne Therapeutics Inc. at 7 sites in Israel.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of FDX104 Antibiotic Foam in the prevention of EGFRI skin toxicity in cancer patients receiving Cetuximab or Panitumumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rash Due to Epidermal Growth Factor Receptor Inhibitors
- What is being tested?
- FDX104 (4% Doxycycline)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 7 sitesIsrael
- Study dates
- Oct 2014to Oct 2015
- Phase
- Phase 2
- 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
- Age 18 years and older
- Subjects with any cancer receiving Cetuximab or Panitumumab on a weekly or every 2 weeks basis.
- Scheduled to start Cetuximab or Panitumumab treatment;
- Males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically sterile, or with a negative subunit hCG pregnancy test immediately prior to study entry.
- Able to understand and provide signed informed consent.
- Ability to reliably apply topical FDX104 and vehicle twice a day to the appropriate part of the face
- Willingness to minimize sun exposure for 5 weeks from randomization
- ECOG performance status 0-2.
Who cannot join
- Prior allergic reaction or severe intolerance to Doxcycycline and/or other tetracyclines.
- Prior allergic reaction or severe intolerance to soy or coconut oil
- Cutaneous metastases on the face or might spread to the face.
- The presence of any active skin disease (e.g., eczema), tattoos or other problems at application site, (i.e., located on the face) that, in the investigator's opinion, could confound the evaluation of the rash or make topical application unacceptable
- Hair on the face (e.g beard) which would interfere with the application of the study drug or its evaluation.
- ANC <1,500/mm3 (or<1.5x109/L), or Platelet count < 100,000/mm3 (or <100x109/L)
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- Abnormal renal functions: Serum creatinine >1.6 mg/dL or 142umol/L (SI units) or calculated estimated creatinine clearance <40 ml/min1.73 m2 based on Cockcroft and Gault formula.
- Abnormal hepatic functions: Serum Aspartate transaminase (AST) or alanine tansaminase (ALT) >5 institutional upper limit of normal (ULN). Or Total billirubin > 2 x institutional ULN or >5 x institutional ULN if documented liver metastasis.
- Any clinically significant safety laboratory 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 on the physical examination that, in the opinion of the Investigator, would place the subject at undue risk if the subject were to participate in the study
- Systemic lupus erythematosus
- Undergoing any current biological treatment for cancer other than the prescribed EGFRI
- Treatment with topical antibiotics, anti-acne medication and other topical treatments on the face within 14 days prior to treatment start. Use of topical corticosteroids within 2 weeks prior to baseline; only mild to moderate topical steroids are allowed outside the head and neck area. The area should not exceed 10% of the whole body surface area. In body folds, such as axillary and inguinal regions, only mild topical steroids are allowed in short term use (≤15 consecutive days).
- Treatment with systemic antibiotics 7 days prior to treatment start.
- Known or suspected pregnancy, or lactation or planned pregnancy (females)
- Previous enrolment in a clinical trial involving investigational drug or a medical device within 30 days before provision of written informed consent for the study
- Subjects who are mentally or physically unable to comply with all aspects of the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Israel7 sites
Soroka Medical Center
Beersheba
Rambam Medical Center
Haifa
Hadassah Medical Center
Jerusalem
Rabin Medical Center
Petah Tikva
Assaf Harofeh medical center
Rishon LeZiyyon
Sourasky medical center
Tel Aviv, 64239
Sheba medical center
Tel HaShomer
About this study
Official title: A Safety, Tolerability and Efficacy Study of Doxycycline Topical Foam Administered Topically for Prevention of Epidermal Growth Factor Receptor Inhibition Skin Toxicity, to Subjects With Cancer Receiving Cetuximab or Panitumumab
The purpose of this study is to evaluate the safety, tolerability and efficacy of FDX104 Antibiotic Foam in the prevention of EGFRI skin toxicity in cancer patients receiving Cetuximab or Panitumumab.
Read the detailed description
This is a phase II multicenter, randomized, double blind, vehicle controlled clinical study to evaluate the safety, tolerability and efficacy of Doxycycline Foam 4% for the prevention of Epidermal Growth Factor Receptor Inhibition Skin Toxicity, to Subjects with Cancer Receiving Cetuximab or Panitumumab on a weekly or every 2 weeks basis.
The study consists of a screening visit, a treatment period where patients will be treated topically on the face twice daily for 5 weeks. A post-treatment follow up visit (4 weeks after end of treatment), will be performed only for subjects who have experienced unresolved possibly-related or related adverse events at the end of the treatment. Seven days after randomization and study drug initiation, subjects will start their EGFRI treatment.
- Being tested
- FDX104 (4% Doxycycline)
- Keywords
- EGFRI, Epidermal Growth Factor Receptor Inhibition, Skin toxicity, Topical, Doxycycline, Foam, Phase II, Cetuximab, Panitumumab, Vectibix, Erbitux, Rash
- Medical subject headings
- Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDX104 (4% Doxycycline)Drug
Also called FDX104 antibiotic foam
FDX104 - 4% or Placebo to be applied twice twice daily during 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| FDX104 (4% Doxycycline) | Experimental | Active ingredient: Doxycycline Concentration: 4% Route: Topical Dosage schedule: Twice daily, morning and evening. Prophylactic treatment to prevent the rash associated with EGFRI treatment. patients will apply a thin layer of the drug twice daily for five weeks to one half of face Receives: Drug: FDX104 (4% Doxycycline) |
| Placebo foam | Placebo comparator | Active ingredient: None Route: Topical Dosage schedule: Twice daily, morning and evening. Patients will apply a thin layer of the placebo twice daily for five weeks to the opposite half of the face of which they received active treatment. Receives: Drug: FDX104 (4% Doxycycline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the safety and tolerability of FDX104 in cancer patients receiving EGFRI
To demonstrate the safety and tolerability of FDX104 in terms of skin tolerability, adverse events, serious adverse events and vital signs in subjects with advanced cancer treated by EGFRI.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rash Due to Epidermal Growth Factor Receptor InhibitorsStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyne Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravit Geva, MD, Principal investigator, Sourasky Medical center, Tel-aviv, IsraelEinat Shacham Shmueli, MD, Principal investigator, Sheba Medical CenterNirit Yarom, MD, Principal investigator, Assaf Harofeh medical center, Beer Yaakov, IsraelValerya Semenysty, MD, Principal investigator, Rambam Health Care CampusAyala Hubert, MD, Principal investigator, Hadassah Medical OrganizationAlexander Gluzman, MD, Principal investigator, Soroka University Medical CenterHadas Prag Nave, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239731
- Sponsor's protocol ID
- FDX104-1
- Status last verified
- Feb 2016
- First submitted
- 10 Sep 2014
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Shacham Shmueli E, Geva R, Yarom N, Hubert A, Keynan R, Kedem TH, Eini M, Tamarkin D, Shirvan M. Topical doxycycline foam 4% for prophylactic management of epidermal growth factor receptor inhibitor skin toxicity: an exploratory phase 2, randomized, double-blind clinical study. Support Care Cancer. 2019 Aug;27(8):3027-3033. doi: 10.1007/s00520-018-4600-8. Epub 2019 Jan 4.
PubMed 30607677
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Tolerability and Efficacy Study of Doxycycline Topical Foam Administered Topically for Prevention of Epidermal Growth Factor Receptor Inhibition Skin Toxicity, to Subjects With Cancer Receiving Cetuximab or Panitumumab
- ClinicalTrials.gov ID
- NCT02239731
- Acronym / sponsor ID
- FDX104-1
- Keywords
- EGFRI, Epidermal Growth Factor Receptor Inhibition, Skin toxicity, Topical, Doxycycline, Foam, Phase II, Cetuximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Sep 2014 (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.
The purpose of this study is to evaluate the safety, tolerability and efficacy of FDX104 Antibiotic Foam in the prevention of EGFRI skin toxicity in cancer patients receiving Cetuximab or Panitumumab.
Detailed description
This is a phase II multicenter, randomized, double blind, vehicle controlled clinical study to evaluate the safety, tolerability and efficacy of Doxycycline Foam 4% for the prevention of Epidermal Growth Factor Receptor Inhibition Skin Toxicity, to Subjects with Cancer Receiving Cetuximab or Panitumumab on a weekly or every 2 weeks basis.
The study consists of a screening visit, a treatment period where patients will be treated topically on the face twice daily for 5 weeks. A post-treatment follow up visit (4 weeks after end of treatment), will be performed only for subjects who have experienced unresolved possibly-related or related adverse events at the end of the treatment. Seven days after randomization and study drug initiation, subjects will start their EGFRI treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FDX104 (4% Doxycycline) | Experimental | Drug: FDX104 (4% Doxycycline)Active ingredient: Doxycycline Concentration: 4% Route: Topical Dosage schedule: Twice daily, morning and evening. Prophylactic treatment to prevent the rash associated with EGFRI treatment. patients will apply a thin layer of the drug twice daily for five weeks to one half of face |
| Placebo foam | Placebo comparator | Drug: FDX104 (4% Doxycycline)Active ingredient: None Route: Topical Dosage schedule: Twice daily, morning and evening. Patients will apply a thin layer of the placebo twice daily for five weeks to the opposite half of the face of which they received active treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years and older
- Subjects with any cancer receiving Cetuximab or Panitumumab on a weekly or every 2 weeks basis.
- Scheduled to start Cetuximab or Panitumumab treatment;
- Males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically sterile, or with a negative subunit hCG pregnancy test immediately prior to study entry.
- Able to understand and provide signed informed consent.
Key exclusion criteria (17 listed)
- Prior allergic reaction or severe intolerance to Doxcycycline and/or other tetracyclines.
- Prior allergic reaction or severe intolerance to soy or coconut oil
- Cutaneous metastases on the face or might spread to the face.
- The presence of any active skin disease (e.g., eczema), tattoos or other problems at application site, (i.e., located on the face) that, in the investigator's opinion, could confound the evaluation of the rash or make topical application unacceptable
- Hair on the face (e.g beard) which would interfere with the application of the study drug or its evaluation.
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 |
|---|---|---|
| FDX104 (4% Doxycycline)Also: FDX104 antibiotic foamFDX104 - 4% or Placebo to be applied twice twice daily during 5 weeks | Drug | FDX104 (4% Doxycycline), Placebo foam |
Primary outcome
To investigate the safety and tolerability of FDX104 in cancer patients receiving EGFRI
Time frame: 9 weeks
To demonstrate the safety and tolerability of FDX104 in terms of skin tolerability, adverse events, serious adverse events and vital signs in subjects with advanced cancer treated by EGFRI.
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 27 Feb 2018.
- Derived from this study: PubMed 30607677Shacham Shmueli E, Geva R, Yarom N, Hubert A, Keynan R, Kedem TH, Eini M, Tamarkin D, Shirvan M. Topical doxycycline foam 4% for prophylactic management of epidermal growth factor receptor inhibitor skin toxicity: an exploratory phase 2, randomized, double-blind clinical study. Support Care Cancer. 2019 Aug;27(8):3027-3033. doi: 10.1007/s00520-018-4600-8. Epub 2019 Jan 4.
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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.
Ravit Geva, MD principal investigator
Sourasky Medical center, Tel-aviv, Israel
Einat Shacham Shmueli, MD principal investigator
Sheba Medical Center
Nirit Yarom, MD principal investigator
Assaf Harofeh medical center, Beer Yaakov, Israel
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FDX104 (4% Doxycycline) in people with Rash Due to Epidermal Growth Factor Receptor Inhibitors, run by Vyne Therapeutics Inc. at 7 sites in Israel.
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 8 inclusion and 17 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 27 Feb 2018. 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 Israel. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 investigate the safety and tolerability of FDX104 in cancer patients receiving EGFRI (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02239731, which also lists 1 linked publication.
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 27 Feb 2018.