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

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Trial Identification

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

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

Study ID: NCT02239731

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Soroka Medical Center, Be'er-Sheva, , Israel

Rambam Medical Center, Haifa, , Israel

Hadassah Medical Center, Jerusalem, , Israel

Rabin Medical Center, Petah-Tikva, , Israel

Assaf Harofeh medical center, Rishon LeZion, , Israel

Sourasky medical center, Tel Aviv, , Israel

Sheba medical center, Tel Hashomer, , Israel

Contact Details

Name: Ravit Geva, MD

Affiliation: Sourasky Medical center, Tel-aviv, Israel

Role: PRINCIPAL_INVESTIGATOR

Name: Einat Shacham Shmueli, MD

Affiliation: Sheba Medical Center

Role: PRINCIPAL_INVESTIGATOR

Name: Nirit Yarom, MD

Affiliation: Assaf Harofeh medical center, Beer Yaakov, Israel

Role: PRINCIPAL_INVESTIGATOR

Name: Valerya Semenysty, MD

Affiliation: Rambam Health Care Campus

Role: PRINCIPAL_INVESTIGATOR

Name: Ayala Hubert, MD

Affiliation: Hadassah Medical Organization

Role: PRINCIPAL_INVESTIGATOR

Name: Alexander Gluzman, MD

Affiliation: Soroka University Medical Center

Role: PRINCIPAL_INVESTIGATOR

Name: Hadas Prag Nave, MD

Affiliation: Rabin Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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