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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02239731 |
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Date of registration:
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10/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety, Tolerability and Efficacy Study of Doxycycline Foam for the Prevention of EGFRI Skin Toxicity in Cancer Patients
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Scientific title:
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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 |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02239731 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Israel
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Contacts
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Name:
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Einat Shacham Shmueli, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sheba Medical Center Tel-Hashomer, Israel |
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Name:
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Nirit Yarom, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assaf Harofeh medical center, Beer Yaakov, Israel |
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Name:
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Ayala Hubert, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hadassah Medical Center |
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Name:
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Valerya Semenysty, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rambam Health Care Campus |
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Name:
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Alexander Gluzman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Soroka University Medical Center |
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Name:
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Hadas Prag Nave, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rabin Medical Center |
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Name:
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Ravit Geva, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sourasky Medical center, Tel-aviv, Israel |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age 18 years and older
2. Subjects with any cancer receiving Cetuximab or Panitumumab on a weekly or every 2
weeks basis.
3. Scheduled to start Cetuximab or Panitumumab treatment;
4. 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.
5. Able to understand and provide signed informed consent.
6. Ability to reliably apply topical FDX104 and vehicle twice a day to the appropriate
part of the face
7. Willingness to minimize sun exposure for 5 weeks from randomization
8. ECOG performance status 0-2.
Exclusion Criteria:
1. Prior allergic reaction or severe intolerance to Doxcycycline and/or other
tetracyclines.
2. Prior allergic reaction or severe intolerance to soy or coconut oil
3. Cutaneous metastases on the face or might spread to the face.
4. 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
5. Hair on the face (e.g beard) which would interfere with the application of the study
drug or its evaluation.
6. ANC <1,500/mm3 (or<1.5x109/L), or Platelet count < 100,000/mm3 (or <100x109/L)
7. 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.
8. 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.
9. 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
10. 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
11. Systemic lupus erythematosus
12. Undergoing any current biological treatment for cancer other than the prescribed EGFRI
13. 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).
14. Treatment with systemic antibiotics 7 days prior to treatment start.
15. Known or suspected pregnancy, or lactation or planned pregnancy (females)
16. 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
17. Subjects who are mentally or physically unable to comply with all aspects of the
study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rash Due to Epidermal Growth Factor Receptor Inhibitors
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Intervention(s)
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Drug: FDX104 (4% Doxycycline)
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Primary Outcome(s)
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To investigate the safety and tolerability of FDX104 in cancer patients receiving EGFRI
[Time Frame: 9 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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