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Autophagy Inhibitor

Trametinib for Bile Duct Cancer

Phase 2
Waitlist Available
Led By Tim F Greten, M.D.
Research Sponsored by National Cancer Institute (NCI)
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 every 2 months up to approximately 10 months
Awards & highlights

Study Summary

This trial is testing a combination of drugs to see if it can slow the progression of bile duct cancer for people with a gene mutation.

Eligible Conditions
  • Bile Duct Cancer
  • Biliary Cancers
  • Biliary Tract Cancer
  • Cholangiocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 months up to approximately 10 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 months up to approximately 10 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median Progression Free Survival (PFS)
Secondary outcome measures
Overall Survival
Proportion of Participants With a Response (Complete Response (CR) + Partial Response (PR) Reported With an 80% Confidence Interval
Proportion of Participants With a Response (Complete Response (CR) + Partial Response (PR) Reported With an 95% Confidence Interval
+1 more
Other outcome measures
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Side effects data

From 2021 Phase 2 trial • 206 Patients • NCT02034110
50%
Nausea
40%
Neutropenia
30%
Diarrhoea
30%
Decreased appetite
30%
Thrombocytopenia
30%
Vomiting
30%
Anaemia
30%
Constipation
30%
Fatigue
30%
Pyrexia
30%
Rash
20%
Infection
20%
Alopecia
20%
Hypokalaemia
20%
Chills
20%
Urinary tract infection
20%
Blood alkaline phosphatase increased
20%
Spinal pain
20%
Mucosal inflammation
20%
Oedema peripheral
20%
Arthralgia
10%
Hypocalcaemia
10%
Confusional state
10%
Microcytic anaemia
10%
Dry eye
10%
Abdominal distension
10%
Dyspnoea
10%
Pain in extremity
10%
Dizziness
10%
Renal failure
10%
Influenza
10%
Cachexia
10%
Abdominal pain
10%
Pain
10%
Oropharyngeal candidiasis
10%
Radiation associated pain
10%
Hypoaesthesia
10%
Retinal detachment
10%
Cough
10%
Small intestinal obstruction
10%
Enterobacter infection
10%
Xeroderma
10%
Urinary tract infection bacterial
10%
Gastrooesophageal reflux disease
10%
Dry mouth
10%
Asthenia
10%
Gait disturbance
10%
Folliculitis
10%
Gastroenteritis
10%
Nasopharyngitis
10%
Rhinitis
10%
Sinusitis
10%
Streptococcal infection
10%
Blood creatinine increased
10%
Blood lactate dehydrogenase increased
10%
C-reactive protein increased
10%
Ejection fraction decreased
10%
Electrocardiogram QT prolonged
10%
Liver function test increased
10%
Weight decreased
10%
Back pain
10%
Bone pain
10%
Flank pain
10%
Muscular weakness
10%
Myalgia
10%
Synovial cyst
10%
Paraesthesia
10%
Depressed mood
10%
Insomnia
10%
Benign prostatic hyperplasia
10%
Lung disorder
10%
Skin mass
10%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Multiple Myeloma (MM) (On-Treatment)
Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)
Biliary Tract Cancer (BTC) (On-Treatment)
Hairy Cell Leukemia (HCL) (On-Treatment)
Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)
Anaplastic Thyroid Cancer (ATC) (On-Treatment)
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)
Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)
High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)
Gastrointestinal Stromal Tumor (GIST) (Post-treatment Survival Follow-up)
Gastrointestinal Stromal Tumor (GIST) (On-Treatment)
Adenocarcinoma of the Small Intestine (ASI) (On-Treatment)
Biliary Tract Cancer (BTC) (Post-treatment Survival Follow-up)
Multiple Myeloma (MM) (Post-treatment Survival Follow-up)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cohort 1/Arm 1: Trametinib + Hydroxychloroquine (HCQ)Experimental Treatment2 Interventions
Trametinib + hydroxychloroquine (HCQ)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
2017
Completed Phase 4
~5360
Trametinib
2014
Completed Phase 2
~1550

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,487 Total Patients Enrolled
Tim F Greten, M.D.Principal InvestigatorNational Cancer Institute (NCI)
20 Previous Clinical Trials
1,463 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 objectives is this clinical experiment striving to accomplish?

"The primary assessment of this 5-month long clinical trial is to establish if the Progression Free Survival (PFS) rate for trametinib plus hydroxychloroquine combination therapy in subjects with refractory bile tract carcinoma and KRAS mutation surpasses 25%. Secondary objectives include calculating Response Rate (RR) with 80% or 95% two-sided confidence intervals, gauging safety by monitoring adverse events frequency, and evaluating Overall Survival (OS) utilising Kaplan-Meier method."

Answered by AI

What is the general purpose of Trametinib in medical treatment?

"Trametinib is a common medication prescribed to treat discoid lupus erythematosus. It may also be useful in managing systemic lupus erythematosus, malaria, and q fever."

Answered by AI

Are there available openings for potential participants in this experiment?

"That is correct. Clinicaltrials.gov has the most recent information, which notes that recruitment for this study began on February 15th 2022 and was recently updated in October 4th 2022. This clinical trial is seeking 30 participants at one site."

Answered by AI

Is Trametinib now an officially sanctioned therapeutic agent?

"Trametinib's safety profile is rated a 2, as this Phase 2 trial has only offered evidence of its security but not efficacy."

Answered by AI

Have any other trials explored Trametinib's effects?

"Currently, Trametinib is the focus of 152 clinical trials around the world. Of these investigations, 13 are in their final phase before FDA approval. The majority of studies involving this drug take place in Hangzhou, Zhejiang; however there are 6363 sites conducting research on its efficacy and safety overall."

Answered by AI

How many volunteers are participating in this scientific experiment?

"Affirmative, according to clinicaltrials.gov the study is presently recruiting participants and was initially posted on February 15th 2022. The most recent update occurred October 4th 2022 and 30 people are required between 1 site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC).
Tim Greten, M.D. 2022. "Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04566133.
~1 spots leftby Apr 2025
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