Cetuximab for Colorectal Cancer

University of Chicago Medical Center, Chicago, IL
Colorectal Cancer+4 More ConditionsCetuximab - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing the safety of combining a new drug (VS-6766) with an existing drug (cetuximab) to treat colorectal cancer. It's for people whose cancer has progressed despite other treatments, or who can't take/tolerate other treatments. If you participate, you'll be in the trial for up to 2 years.

Eligible Conditions
  • Colorectal Cancer
  • Metastatic Colorectal Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

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Study Objectives

2 Primary · 9 Secondary · Reporting Duration: 2 years

2 months
Phase 2 Objective: Two-Month Progression-Free Survival
2 years
Phase 1 Objective: Frequency/ Type of Dose-Limiting Toxicities (Serious Side Effects) Reported Among Participants Taking VS-6766 and Cetuximab
Phase 1 Objective: The Number of Dose-Limiting Toxicities (Serious Side Effects) Reported Among Participants Taking VS-6766 and Cetuximab
Phase 2 Objective: Duration of Response
Phase 2 Objective: Overall Survival
Phase 2 Objective: Progression-Free Survival (PFS)
Phase 2 Primary Objective: Objective Response Rate of Participants Who Take Phase I /MTD Dose of VS-6766 combined with Cetuximab
Phase I Primary Objective: Maximum Tolerated Dose (MTD) of VS-6766 combined with Cetuximab
4 months
Phase II Objective: Complete Response
Phase II Objective: Partial Response
Phase II Objective: Stable Disease

Trial Safety

Phase-Based Safety

1 of 3

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Cetuximab
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Side Effects for

Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase
43%Leucopenia
43%Weight Decreased
40%Nausea
35%Rash
34%Hypomagnesaemia
32%Hypokalemia
31%Constipation
28%Neutropenia
28%Vomiting
26%Decreased Appetite
22%Pyrexia
19%Hyponatremia
19%Hemoglobin Decreased
19%Acne
18%Diarrhea
18%Stomatitis
15%Fatigue
15%Pruritus
13%Mucosal Inflammation
13%Neutrophil Count Decreased
12%Mouth Ulceration
10%Thrombocytopenia
10%Asthenia
10%Insomnia
9%Cough
9%White Blood Cell Count Decreased
9%Dizziness
7%Abdominal Pain Upper
7%Aspartate Aminotransferase Increased
7%Paronychia
7%Hypochloremia
7%Weight Increased
7%Hypocalcaemia
7%Dermatitis Acneiform
6%Oral Pain
6%Headache
6%Neck pain
6%Dyspnoea
3%Anaphylactic reaction
1%Pulmonary embolism
1%Toxic encephalopathy
1%Myocardial infarction
1%Staphylococcal skin infection
1%Microcytic anemia
1%Electrolyte imbalance
1%Tumor hemorrhage
1%Pneumonia
1%Mouth hemorrhage
1%Pneumonitis
1%Venous thrombosis
1%Respiratory alkalosis
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01177956) in the Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase ARM group. Side effects include: Leucopenia with 43%, Weight Decreased with 43%, Nausea with 40%, Rash with 35%, Hypomagnesaemia with 34%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

5 Treatment Groups

Phase 1(Dose-Finding Arm): Group 1 - Dose Level 1 (Starting Dose)
1 of 5
Phase 1(Dose-Finding Arm): Group 4 - Lower Dose Level 2
1 of 5
Phase 1(Dose-Finding Arm): Group 2- Dose Level 2 (Second Highest Dose)
1 of 5
Phase 1(Dose-Finding Arm): Group 3 - Lower Dose Level 1
1 of 5
Phase 2 (Efficacy Arm/ Expansion Cohort)
1 of 5

Experimental Treatment

53 Total Participants · 5 Treatment Groups

Primary Treatment: Cetuximab · No Placebo Group · Phase 1 & 2

Phase 1(Dose-Finding Arm): Group 1 - Dose Level 1 (Starting Dose)Experimental Group · 2 Interventions: VS-6766, Cetuximab · Intervention Types: Drug, Drug
Phase 1(Dose-Finding Arm): Group 4 - Lower Dose Level 2Experimental Group · 2 Interventions: VS-6766, Cetuximab · Intervention Types: Drug, Drug
Phase 1(Dose-Finding Arm): Group 2- Dose Level 2 (Second Highest Dose)Experimental Group · 2 Interventions: VS-6766, Cetuximab · Intervention Types: Drug, Drug
Phase 1(Dose-Finding Arm): Group 3 - Lower Dose Level 1Experimental Group · 2 Interventions: VS-6766, Cetuximab · Intervention Types: Drug, Drug
Phase 2 (Efficacy Arm/ Expansion Cohort)Experimental Group · 3 Interventions: VS-6766, Cetuximab, Pill Diary · Intervention Types: Drug, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VS-6766
2021
Completed Phase 1
~20
Cetuximab
2011
Completed Phase 3
~2400

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

University of ChicagoLead Sponsor
951 Previous Clinical Trials
759,507 Total Patients Enrolled
Verastem, Inc.Industry Sponsor
35 Previous Clinical Trials
2,109 Total Patients Enrolled
Ardaman S. Shergill, MDPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
California100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

How many individuals are enrolled in this research endeavor?

"Affirmative. The information hosted on clinicaltrials.gov indicates that recruitment for this trial is currently active, commencing from August 22nd 2022 and last updated September 30th 2022. There are 53 spots open at one research centre." - Anonymous Online Contributor

Unverified Answer

Has this clinical study opened its enrollment period yet?

"The trial, which was first listed on August 22nd 2022, is still actively searching for participants. The study details were last edited on September 30th 2022." - Anonymous Online Contributor

Unverified Answer

What are the primary goals of this clinical experiment?

"This two-year clinical trial seeks to measure the Maximum Tolerated Dose (MTD) of VS-6766 combined with Cetuximab. Secondary objectives include determining the frequency/type of dose-limiting toxicities reported among participants, assessing duration of response and stable disease as determined by medical records and statistical analysis respectively." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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