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Monoclonal Antibodies

Triple Therapy for Advanced Solid Cancers

Phase 1

Waitlist Available

Led By David S Hong

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Cancers with positive BRAF V600 mutation detected by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 weeks

Awards & highlights

Study Summary

This trial is testing the side effects and best dose of vemurafenib when given with cetuximab and irinotecan hydrochloride to treat patients with solid tumors. Vemurafenib and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cetuximab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Who is the study for?

This trial is for patients with solid tumors that have spread or can't be surgically removed, and who have a specific BRAF V600 mutation. They should not have received recent tumor treatment, must be able to swallow pills, and agree to use contraception. Those with severe medical conditions or certain heart issues are excluded.Check my eligibility

What is being tested?

The trial tests the combination of vemurafenib, cetuximab, and irinotecan hydrochloride on patients with advanced solid tumors. It aims to find the safest dose while assessing how these drugs affect tumor growth by blocking enzymes and boosting the immune system's response.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as skin rash or infusion-related symptoms, liver enzyme changes indicating potential liver damage, fatigue from anemia or low blood counts due to bone marrow suppression, digestive disturbances like diarrhea or constipation.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has a BRAF V600 mutation.

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer has spread and cannot be removed with surgery.

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My tumor is K-RAS wild-type.

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My liver function tests are within the required limits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum tolerated dose of vemurafenib defined as the highest dose studied in which the incidence of dose limiting toxicity was less than 33% as graded by the National Cancer Institute Common Toxicity Criteria version 4.0

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (vemurafenib, cetuximab, irinotecan hydrochloride)Experimental Treatment5 Interventions

Patients receive vemurafenib PO BID on days 1-14, cetuximab IV over 90 minutes, and irinotecan hydrochloride IV over 90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vemurafenib

2015

Completed Phase 3

~3100

Cetuximab

2011

Completed Phase 3

~2480

Irinotecan Hydrochloride

2010

Completed Phase 3

~1940

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,748 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,120 Total Patients Enrolled

Genentech, Inc.Industry Sponsor

1,539 Previous Clinical Trials

567,656 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01787500 — Phase 1

Frequently Asked Questions

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

How is Pharmacological Study typically implemented?

"Pharmacological Study is employed to treat inoperable melanoma, but it also has potential benefits for individuals afflicted with colorectal carcinoma, ovarian cancer and sarcoma."

Answered by AI

To what extent is pharmacological research risky to individuals?

"As this is a preliminary stage 1 trial, with limited data supporting its safety and effectiveness, it has been given an estimated score of 1."

Answered by AI

Are applications being accepted at this time for participation in the experiment?

"At this juncture, no further volunteers are being invited to participate in this medical trial. The initial posting was on February 15th 2013 and the most recent update occurred on September 22nd 2022. There is a wealth of other trials currently recruiting participants with metastatic malignant solid neoplasms (3139) as well as pharmacological studies (396)."

Answered by AI

Are there any other investigations involving Pharmacological Study that have been completed?

"Presently, 396 clinical trials researching Pharmacological Study are conducting operations. Of these active studies, 77 are in their third phase. These investigations take place chiefly out of Pittsburgh, Pennsylvania but there are 13762 sites across the country working on it as well."

Answered by AI

How many participants can this research accommodate?

"This trial is no longer admitting candidates. The experiment was initially posted on February 15th 2013 and last edited September 22nd 2022. There are currently 3139 trials actively recruiting for metastatic malignant solid neoplasm, as well 396 studies searching for participants to partake in a Pharmacological Study."

Answered by AI

Recent research and studies

brafJournal

Phase IB Study of Vemurafenib in Combination with Irinotecan and Cetuximab in Patients with Metastatic Colorectal Cancer with <i>braf</i>v600e Mutation

Hong, David S., Van K. Morris, Badi El Osta, Alexey V. Sorokin, Filip Janku, Siqing Fu, Michael J. Overman, et al.. 2016. “Phase IB Study of Vemurafenib in Combination with Irinotecan and Cetuximab in Patients with Metastatic Colorectal Cancer with brafv600e Mutation”. Cancer Discovery. American Association for Cancer Research (AACR). doi:10.1158/2159-8290.cd-16-0050.

clinicaltrials.govStudy

Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery

2013. "Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01787500.

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