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Anti-metabolites

trametinib for Rectal Cancer

Phase 1
Waitlist Available
Led By Terence Williams, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
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 up to 5 years
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of trametinib when given with fluorouracil and radiation therapy before surgery, in order to treat patients with stage II-III rectal cancer.

Eligible Conditions
  • Rectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Identify the maximally tolerated dose of Trametinib to be used in combination with 5FU and radiation in patients with rectal cancers.
Secondary outcome measures
Frequency of dose-limiting toxicities, assessed according to the NCI CTCAE version 4
Frequency of patients undergoing sphincter preserving surgery
Local failure rate
+3 more

Side effects data

From 2016 Phase 2 trial • 12 Patients • NCT01928940
67%
Aspartate aminotransferase increased
67%
Pyrexia
67%
Oedema peripheral
50%
Neutropenia
50%
Stomatitis
33%
Arthralgia
33%
Nasopharyngitis
33%
Headache
33%
Hypophosphataemia
33%
Blood alkaline phosphatase increased
33%
Constipation
33%
Anaemia
17%
Platelet count decreased
17%
Mitral valve incompetence
17%
Leukopenia
17%
Blood glucose increased
17%
Deafness neurosensory
17%
Blood phosphorus decreased
17%
Blood albumin decreased
17%
Blood lactate dehydrogenase increased
17%
Blood pressure increased
17%
Ejection fraction decreased
17%
Glucose urine present
17%
White blood cell count decreased
17%
Nausea
17%
Vomiting
17%
Myalgia
17%
Pain in extremity
17%
Erythema
17%
Pneumonia bacterial
17%
Neuropathy peripheral
17%
Cough
17%
Thermal burn
17%
Diarrhoea
17%
Erythema nodosum
17%
Chills
17%
Retinal vascular disorder
17%
Bronchitis
17%
Retinal detachment
17%
Gingival bleeding
17%
Rhinitis allergic
17%
Dermatitis acneiform
17%
Lip dry
17%
Alanine aminotransferase increased
17%
Mechanical urticaria
17%
Skin fissures
17%
Malaise
17%
Uveitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase II: GSK2118436 150 mg + GSK1120212 2 mg
Phase I: GSK2118436 150 mg + GSK1120212 2 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (trametinib, fluorouracil, radiation, surgery)Experimental Treatment3 Interventions
Patients receive trametinib PO (by mouth) QD (daily) on days -14 through -10 and 1-38 and fluorouracil IV continuously 5 days a week from days 1-38. Patients also undergo radiation therapy 5 days a week on days 1-33. Patients then undergo surgery 6-10 weeks later. Patients achieving negative surgical margins after complete resection of tumor receive postoperative chemotherapy comprising leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 and 15 OR oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
fluorouracil
1994
Completed Phase 3
~8440
radiation therapy
1994
Completed Phase 3
~13390
trametinib
2012
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsIndustry Sponsor
2,855 Previous Clinical Trials
4,197,331 Total Patients Enrolled
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,148 Total Patients Enrolled
National Comprehensive Cancer NetworkNETWORK
115 Previous Clinical Trials
7,616 Total Patients Enrolled

Frequently Asked Questions

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

What indications is trametinib commonly prescribed for?

"Trametinib is widely utilised to treat actinic keratosis, as well as more serious conditions like metastatic melanoma, unresectable melanoma and superficial basal cell carcinoma."

Answered by AI

Has there been any previous experimentation involving trametinib?

"Currently, 405 clinical trials are underway that involve trametinib. Of those active studies, 108 have reached Phase 3 testing with the majority of locations running these tests based in Woolloongabba, Queensland. Internationally, 23582 sites are involved in this research project."

Answered by AI

What is the current number of medical institutions conducting this experiment?

"Five clinical sites are currently running this trial. These include Roswell Park Cancer Institute in Buffalo, Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center in Columbus, Washington University in Saint Louis, as well as other medical centres located throughout the United States."

Answered by AI

Are there any slots remaining in this study for new participants?

"This medical trial is not currently open for enrollment. Initially posted on November 26th 2012 and last updated February 15th 2022, the study has been closed to new participants since then. For those seeking alternative studies, 306 clinical trials are enlisting patients with rectal carcinoma and 405 involving trametinib remain active."

Answered by AI

What is the enrollment capacity for this clinical trial?

"As of February 15th 2022, this medical trial has ceased recruiting participants. It was initially posted on November 26th 2012 and its last update was on the aforementioned date. There are presently 306 clinical trials eagerly seeking patients with rectal carcinoma while 405 studies are actively looking for volunteers to test trametinib's efficacy."

Answered by AI

Does trametinib meet the necessary requirements for Food and Drug Administration ratification?

"Trametinib is ranked a 1 on the safety scale, as there are few studies that back up its efficacy and security in human subjects."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Treating Patients With Stage II-III Rectal Cancer
Sameek Roychowdhury 2012. "Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Treating Patients With Stage II-III Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01740648.
~2 spots leftby Apr 2025
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