Topical Tazarotene Vs Placebo In Hand-Foot-Skin Reactions

NCT04071756 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 19-099
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This research is studying the preventative use of topical 0.1% tazarotene gel daily in addition to best practice standards to reduce the development of hand-foot skin reaction (HFSR).

Conditions

Solid Tumor; Hand-Foot Skin Reaction (HFSR)

Keywords

Solid Tumor; Hand-Foot Skin Reaction (HFSR)

Outcome Measures

Primary Outcomes (2)

• Grade 2 or Higher Hand-Foot Skin Reaction (HFSR) Rate

  Grade 2 or higher hand-foot skin reaction (HFSR) Rate defined as the percentage of patients in each arm who develop grade-2 or higher HFSR within the first 8 weeks of protocol therapy. Measured via examination by a Dermatology Provider and grading according to CTCAE version 5.

  Up to 8 weeks

• All Grade Hand-Foot Skin Reaction (HFSR) Rate

  Any grade hand-foot skin reaction (HFSR) Rate defined as the percentage of patients in each arm who develop HFSR within the first 8 weeks of protocol therapy. Measured via examination by a Dermatology Provider and grading according to CTCAE version 5.

  Up to 8 weeks

Secondary Outcomes (2)

• Change in HFS-14 Score From Baseline to Day 56

  At baseline and at day 56.

• Change in Perceived Stress Scale (PSS) From Baseline to Day 56

  at baseline and day 56

Study Arms (2)

Topical Tazarotene 0.1% Gel Plus BPS

EXPERIMENTAL

* Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning + tazarotene 0.1% gel, applied to the palms and soles nightly

Drug: Topical Tazarotene

Placebo Gel Plus BPS

PLACEBO COMPARATOR

* A substance that has no therapeutic effect, used as a control in testing new drugs * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning with placebo gel applied in the evening.

Other: Placebo

Interventions

Topical Tazarotene DRUG

This medicine works by making the skin less inflamed and reducing the thickness and pain from lesions of the skin

Also known as: Tazorac

Topical Tazarotene 0.1% Gel Plus BPS

Placebo OTHER

A substance that has no therapeutic effect, used as a control in testing new drugs

Placebo Gel Plus BPS

Eligibility Criteria

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

You may qualify if:

• Participants must have histologically or cytologically confirmed solid tumors with a plan to initiate regorafenib, or having started regorafenib in the last 48 hours, via dose escalation protocol describe in the ReDOS study in CRC. The ReDOS study recommends this dose escalation of regorafenib:80mg daily x 1 week, 120mg daily x 1 week, 160mg daily times one week, off week, then 160mg daily goal, or maximum tolerated dose thereafter. This is not a separate study; this is the current standard of care for regorafenib dosing. In addition, to compare across the cohorts, patients must be ambulatory with full use of all 4 distal extremities.
• Age ≥ 18
• ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
• Participants must have sufficient organ and marrow function in the opinion of the treating investigator. This can be based on lab reports from an outside facility.
• Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation Tazarotene is known to be teratogenic, although the dose required with topical application to affect the developing human fetus is unknown. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of administration.
• Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test.
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Regorafenib use in combination with another TKI (unless regorafenib was started in the last 48 hours)
• Pregnancy or non-compliance with contraception (4 weeks before, during and for at least 3 ovulatory cycles after treatment cessation). Pregnant women are excluded from this study because tazarotene is category X with the potential for teratogenic or abortifacient effects.
• Nursing or lactating: Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tazarotene, breastfeeding should be discontinued if the mother is treated.
• A history of hypervitaminosis A
• Other systemic retinoids needed for another condition (ie. Isotretinoin for inflammatory acne, acitretin for psoriasis, bexarotene for CTCL).
• Need for treatment dose systemic steroids or systemic immunosuppressive agents (i.e., for autoimmune disease or cerebral edema) at the time of enrolment
• Psoriasis or other autoimmune disease requiring skin directed or systemic therapy known to impact keratinocyte proliferation (UV therapy to the hands or feet, TNF inhibitors, etc).
• Active skin disease of the hands or feet with redness, scaling or blisters prior to enrolment
• Participants who have had any systemic chemotherapy or immunotherapy within 4 weeks prior to entering the study AND who have not recovered from adverse events on the hands and feet due to the agents administered.
• Participants who are receiving any other investigational agents to treat HFSR.
• Uncontrolled intercurrent illness including, but not limited to, uncontrolled lower extremity edema, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Bayer: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

tazarotene

Limitations and Caveats

This study was terminated prematurely on 7/14/2022 as there had been significant difficulty with patient recruitment. This report includes data for eight (8) randomized participants. The first enrolled on December 30, 2019, and the last on July 28, 2020.

Results Point of Contact

• Title: Nicole LeBoeuf, MD, MPH
• Organization: Dana-Farber Cancer Institute

nicole_leboeuf@dfci.harvard.edu

617-632-6571

Study Officials

• Nicole LeBoeuf, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: August 28, 2019
• Study Start: December 30, 2019
• Primary Completion: June 12, 2021
• Study Completion: July 14, 2022
• Last Updated: February 7, 2024
• Results First Posted: November 15, 2023

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)