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

NCT02239731 | Completed Phase 2

• 1 other identifier: FDX104-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

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.

Conditions

Rash Due to Epidermal Growth Factor Receptor Inhibitors

Keywords

EGFRI; Epidermal Growth Factor Receptor Inhibition; Skin toxicity; Topical; Doxycycline; Foam; Phase II; Cetuximab; Panitumumab; Vectibix; Erbitux; Rash

Outcome Measures

Primary Outcomes (1)

• 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.

  9 weeks

Other Outcomes (1)

• Reduction of skin toxicity by FDX104 in cancer patients treated with EGFRI

  9 weeks

Study Arms (2)

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

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.

Drug: FDX104 (4% Doxycycline)

Interventions

FDX104 (4% Doxycycline) DRUG

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

Also known as: FDX104 antibiotic foam

FDX104 (4% Doxycycline); Placebo foam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

Study Sites (7)

Soroka Medical Center

Beersheba, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Hadassah Medical Center

Jerusalem, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Assaf Harofeh medical center

Rishon LeZiyyon, Israel

Location

Sourasky medical center

Tel Aviv, 64239, Israel

Location

Sheba medical center

Tel Litwinsky, Israel

Location

Related Publications (1)

• 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.

  PMID: 30607677 DERIVED

MeSH Terms

Conditions

Exanthema

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Ravit Geva, MD

  Sourasky Medical center, Tel-aviv, Israel

  PRINCIPAL INVESTIGATOR

• Einat Shacham Shmueli, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Nirit Yarom, MD

  Assaf Harofeh medical center, Beer Yaakov, Israel

  PRINCIPAL INVESTIGATOR

• Valerya Semenysty, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

• Ayala Hubert, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

• Alexander Gluzman, MD

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

• Hadas Prag Nave, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 15, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 27, 2018

Record last verified: 2016-02

Locations

IL (7)