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Small Molecule

Rigosertib for Skin Cancer in Dystrophic Epidermolysis Bullosa

Q: Is the age restriction for this research study higher than 25 years old?

Applicants who are between 18 and 79 years old can qualify for this clinical trial. Those either younger or older than that age range possess 23 trials available to them, respectively.

Q: Am I a viable candidate for this investigation?

This trial is taking applications from 6 individuals aged 18-79 with <a href="https://www.withpower.com/clinical-trials/epidermolysis-bullosa">epidermolysis bullosa</a>. Crucially, patients must fulfill the following criteria: an authorized representative has given consent for participation; diagnosis of RDEB associated unresectable SCC confirmed before screening visit; failure to respond to conventional treatments such as chemotherapy and radiotherapy or alternative biologic therapies like cetuximab or nivolumab; not currently receiving any other <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> therapy; measurable disease according to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

Q: Are medical practitioners currently enrolling individuals in this investigation?

According to clinicaltrials.gov, this study is actively recruiting and has remained active since first posted on August 24th 2021 with the last update occurring on September 7th 2022.

Q: How many individuals are enrolled in the current experiment?

That is correct. According to the information on clinicaltrials.gov, this medical trial remains open and active for recruitment. The research was initially posted on August 24th 2021, with its last edit occurring September 7th 2022. 6 participants are needed from a single location to complete the study's enrolment requirements.

Phase < 1

Recruiting

Led By Neda Nikbakht, MD, PhD

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not currently receiving any other cancer therapy

Failure to respond to SCC standard of care treatments such as surgical excision, radiotherapy, and conventional chemotherapy with specific agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to12 months post treatment

Awards & highlights

Study Summary

This trial is testing how well rigosertib sodium works in treating patients with RDEB who also have locally advanced SCC. Rigosertib may only affect EB cancer cells and not normal EB cells.

Who is the study for?

This trial is for adults aged 18-79 with Recessive Dystrophic Epidermolysis Bullosa (RDEB) who have Squamous Cell Carcinoma (SCC) that hasn't improved after standard treatments. Participants must not be on other cancer therapies, should understand the study and agree to participate, and need measurable SCC based on certain criteria. Pregnant women, those with active infections like HIV or hepatitis, uncontrolled health issues, or abnormal lab results can't join.Check my eligibility

What is being tested?

The trial is testing how well rigosertib sodium works in treating patients with advanced skin cancer associated with RDEB. The goal is to see if rigosertib targets cancer cells without harming normal cells. Patients' quality of life will also be assessed during the study.See study design

What are the potential side effects?

While specific side effects of rigosertib are not listed here, common side effects from similar medications may include nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems. Allergic reactions to medication components could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not on any cancer treatment right now.

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My skin cancer hasn't improved with standard treatments like surgery, radiation, or chemotherapy.

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I am between 18 and 79 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to12 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to12 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to12 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of treatment-related adverse events

Overall Response Rate (ORR)

Secondary outcome measures

Biomarker Analysis

Efficacy of rigosertib sodium treatment: The Objective Response Rate

Quality of Life Epidermolysis Bullosa (QOLEB) questionnaire

Other outcome measures

Exosome sequencing

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (rigosertib sodium)Experimental Treatment2 Interventions

Patients receive rigosertib sodium either oral or IV over a 52 week period. Patients will take oral rigosertib continuously for a total of three weeks, every four-week cycle (three weeks on, one week off drug). For IV, rigosertib is administered as a 72-hr continuous infusion on Days 1, 2 and 3 of a 2-week cycle for the first eight 2-week cycles, then on Days 1, 2 and 3 of a 4-week cycle thereafter.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,483 Total Patients Enrolled

Onconova Therapeutics, Inc.Industry Sponsor

31 Previous Clinical Trials

1,655 Total Patients Enrolled

Neda Nikbakht, MD, PhDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age restriction for this research study higher than 25 years old?

"Applicants who are between 18 and 79 years old can qualify for this clinical trial. Those either younger or older than that age range possess 23 trials available to them, respectively."

Answered by AI

Am I a viable candidate for this investigation?

"This trial is taking applications from 6 individuals aged 18-79 with epidermolysis bullosa. Crucially, patients must fulfill the following criteria: an authorized representative has given consent for participation; diagnosis of RDEB associated unresectable SCC confirmed before screening visit; failure to respond to conventional treatments such as chemotherapy and radiotherapy or alternative biologic therapies like cetuximab or nivolumab; not currently receiving any other cancer therapy; measurable disease according to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)."

Answered by AI

Are medical practitioners currently enrolling individuals in this investigation?

"According to clinicaltrials.gov, this study is actively recruiting and has remained active since first posted on August 24th 2021 with the last update occurring on September 7th 2022."

Answered by AI

How many individuals are enrolled in the current experiment?

"That is correct. According to the information on clinicaltrials.gov, this medical trial remains open and active for recruitment. The research was initially posted on August 24th 2021, with its last edit occurring September 7th 2022. 6 participants are needed from a single location to complete the study's enrolment requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rigosertib in Patients With Recessive Dystrophic Epidermolysis Bullosa Associated SCC

2021. "Rigosertib in Patients With Recessive Dystrophic Epidermolysis Bullosa Associated SCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04177498.

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