Safety, Tolerability and Efficacy Study of Doxycycline Foam for the Prevention of EGFRI Skin Toxicity in Cancer Patients

NCT ID: NCT02239731

Last Updated: 2018-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-10-31

Brief 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.

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.

Conditions

Rash Due to Epidermal Growth Factor Receptor Inhibitors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

FDX104 (4% Doxycycline)

Intervention Type: DRUG

FDX104 - 4% or Placebo to be applied twice twice daily during 5 weeks

Placebo foam

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.

Group Type: PLACEBO_COMPARATOR

FDX104 (4% Doxycycline)

Intervention Type: DRUG

FDX104 - 4% or Placebo to be applied twice twice daily during 5 weeks

Interventions

FDX104 (4% Doxycycline)

FDX104 - 4% or Placebo to be applied twice twice daily during 5 weeks

Intervention Type: DRUG

Other Intervention Names

FDX104 antibiotic foam

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vyne Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ravit Geva, MD

Role: PRINCIPAL_INVESTIGATOR

Sourasky Medical center, Tel-aviv, Israel

Einat Shacham Shmueli, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Nirit Yarom, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf Harofeh medical center, Beer Yaakov, Israel

Valerya Semenysty, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Ayala Hubert, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Alexander Gluzman, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Hadas Prag Nave, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Soroka Medical Center

Beersheba, , Israel

Rambam Medical Center

Haifa, , Israel

Hadassah Medical Center

Jerusalem, , Israel

Rabin Medical Center

Petah Tikva, , Israel

Assaf Harofeh medical center

Rishon LeZiyyon, , Israel

Sourasky medical center

Tel Aviv, , Israel

Sheba medical center

Tel Litwinsky, , Israel

Countries

Israel

References

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.

Reference Type: DERIVED

PMID: 30607677 (View on PubMed)

Other Identifiers

FDX104-1

Identifier Type: -

Identifier Source: org_study_id