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Kinase Inhibitor

Pharmacological Study for Colorectal Cancer

Phase 2

Waitlist Available

Led By Tanios Bekaii-Saab

Research Sponsored by Academic and Community Cancer Research United

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from randomization to disease progression, where pd is defined by recist 1.1, assessed up to 2 years

Awards & highlights

Study Summary

This trial is studying how well lower-dose regorafenib works compared to standard dose regorafenib in treating patients with colorectal cancer that has spread to other places in the body and does not respond to treatment.

Eligible Conditions

Colorectal Cancer
Rectal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from randomization to disease progression, where pd is defined by recist 1.1, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from randomization to disease progression, where pd is defined by recist 1.1, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from randomization to disease progression, where pd is defined by recist 1.1, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Proportion of Patients in Each Arm Who Complete 2 Cycles of Protocol Treatment and Initiate Cycle 3

Secondary outcome measures

Changes in QOL (According to the Linear Analogue Self-Assessment [LASA] Questionnaire)

Changes in Quality of Life (QOL) (According to the HFS14 Questionnaire)

Cumulative (Total) Dose of Regorafenib Received by Patients in the First Two Cycles

+5 more

Other outcome measures

Pharmacokinetics (PK) Parameters of Regorafenib Using Liquid Chromatography Mass Spectrometry

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm B2 (standard dose regorafenib, reactive clobetasol)Experimental Treatment4 Interventions

Patients receive standard dose regorafenib PO as in Arm B1 and reactive clobetasol propionate as in Arm A2.

Group II: Arm B1 (standard dose regorafenib, pre-emptive clobetasol)Experimental Treatment4 Interventions

Patients receive standard dose regorafenib PO QD on days 1-21 and pre-emptive clobetasol propionate as in Arm A1.

Group III: Arm A2 (lower-dose regorafenib, reactive clobetasol)Experimental Treatment4 Interventions

Patients receive lower-dose regorafenib PO as in Arm A1 and reactive clobetasol propionate given topically BID beginning on day 1 per physician discretion upon occurrence of PPES grade >= 1.

Group IV: Arm A1 (lower-dose regorafenib, pre-emptive clobetasol)Experimental Treatment4 Interventions

Patients receive lower-dose regorafenib PO QD on days 1-21 and pre-emptive clobetasol propionate given topically BID for 12 weeks, beginning on day 1 of regorafenib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Regorafenib

2014

Completed Phase 2

~1580

Clobetasol Propionate

2015

Completed Phase 3

~500

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,925,758 Total Patients Enrolled

Academic and Community Cancer Research UnitedLead Sponsor

53 Previous Clinical Trials

5,013 Total Patients Enrolled

Tanios Bekaii-SaabPrincipal InvestigatorAcademic and Community Cancer Research United

6 Previous Clinical Trials

123 Total Patients Enrolled

Frequently Asked Questions

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

Does this research project have a wide geographical scope?

"There are a total of 22 medical centres that are participating in this clinical trial. A few examples include Illinois CancerCare-Peoria, Wellmont Medical Associates Oncology and Hematology-Kingsport, University of Nebraska Medical Center."

Answered by AI

Is this research unique in any way?

"Since 2013, when the first trial was conducted, there has been significant research investment in Pharmacological Study. The Phase 2 drug approval came after the initial study in 2013 that had 11 participants. Now, across 31 countries and 428 cities, there are 67 live trials for this medication."

Answered by AI

What is the full scope of subjects in this clinical trial?

"Unfortunately, this study is no longer recruiting patients. The clinical trial was initially posted on March 27th, 2015 and updated January 5th, 2022. There are presently 1641 studies actively looking for patients with colorectal carcinoma and 67 studies for Pharmacological Study actively recruiting participants."

Answered by AI

How does the data collected from this Pharmacological Study impact people's safety?

"Pharmacological Study rates a 2 in terms of safety. This is due to the fact that this drug, while having some evidence backing its safety measures, has not been proven effective yet."

Answered by AI

Are recruitment efforts for this research still ongoing?

"At the moment, this study is not enrolling patients. It was first posted on March 27th, 2015 and updated January 5th, 2020. There are 1641 other trials currently recruiting participants for colorectal carcinoma and 67 for Pharmacological Study."

Answered by AI

Why do people commonly take Pharmacological Study?

"The pharmacological study is most often used to treat pruritus, but it can also be used as a treatment for sorafenib, severe plaque psoriasis, and metastatic colorectal cancer (crc)."

Answered by AI

Are there any other relevant clinical trials to compare this one too?

"The first pharmacological study was completed in 2013 at Memorial Sloan Kettering Cancer Center Sleepy Hollow. So far, a total of 424 clinical trials have been conducted on this topic. At the moment, 67 different active studies are underway; with many of these investigations taking place in Peoria, Illinois."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Regorafenib Dose-optimisation in Patients with Refractory Metastatic Colorectal Cancer (redos): A Randomised, Multicentre, Open-label, Phase 2 Study

Bekaii-Saab, Tanios S, Fang-Shu Ou, Daniel H Ahn, Patrick M Boland, Kristen K Ciombor, Erica N Heying, Travis J Dockter, et al.. 2019. “Regorafenib Dose-optimisation in Patients with Refractory Metastatic Colorectal Cancer (redos): A Randomised, Multicentre, Open-label, Phase 2 Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(19)30272-4.

BMC CancerJournal

Retrospective Study of RAS/PIK3CA/BRAF Tumor Mutations as Predictors of Response to First-line Chemotherapy with Bevacizumab in Metastatic Colorectal Cancer Patients

Nakayama, Izuma, Eiji Shinozaki, Tomohiro Matsushima, Takeru Wakatsuki, Mariko Ogura, Takashi Ichimura, Masato Ozaka, et al.. 2017. “Retrospective Study of RAS/PIK3CA/BRAF Tumor Mutations as Predictors of Response to First-line Chemotherapy with Bevacizumab in Metastatic Colorectal Cancer Patients”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-016-2994-6.

clinicaltrials.govStudy

Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer

2015. "Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02368886.