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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients greater than or equal to 18 years of age.
Performance status (ECOG) 0-1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 42 months
Awards & highlights
Study Summary
This trial is testing a new drug called GNS561 in combination with trametinib for people with advanced KRAS mutated cholangiocarcinoma. The trial will look at the safety,
Who is the study for?
This trial is for adults over 18 with advanced bile duct cancer (cholangiocarcinoma) that has a KRAS mutation and has worsened despite chemotherapy. Participants must have at least one measurable disease, be in good physical condition (ECOG 0-1), and have normal organ function. Women of childbearing age must test negative for pregnancy and use birth control; men must agree to contraception methods.Check my eligibility
What is being tested?
The study tests the combination of two drugs, GNS561 and Trametinib, on patients with cholangiocarcinoma who've had no success with first-line therapy. It's an early-phase trial assessing safety, how the body processes the drugs, their effects on the body, and their effectiveness against this type of cancer.See study design
What are the potential side effects?
Potential side effects may include issues related to liver function due to GNS561's targeting mechanism as well as skin rash or heart problems from Trametinib since it affects cell growth pathways.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am fully active or can carry out light work.
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My bile duct cancer has a KRAS mutation.
Select...
My condition cannot be cured with current treatments.
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My blood counts and organ functions are within normal ranges.
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I have undergone at least one chemotherapy treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 42 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 42 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose limiting toxicity (DLT) of GNS561 with trametinib (Phase 1b)
Objective response rate (ORR) of the combination of GNS561 with trametinib (Phase 2a)
Secondary outcome measures
Disease Control Rate (DCR)
Drug concentration in plasma for GNS561 and trametinib
Duration of response (DoR)
+6 moreSide effects data
From 2021 Phase 2 trial • 206 Patients • NCT0203411050%
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%
Microcytic anaemia
10%
Confusional state
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)
Biliary Tract Cancer (BTC) (On-Treatment)
Anaplastic Thyroid Cancer (ATC) (On-Treatment)
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)
Hairy Cell Leukemia (HCL) (On-Treatment)
High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)
Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)
Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)
Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
Gastrointestinal Stromal Tumor (GIST) (On-Treatment)
Gastrointestinal Stromal Tumor (GIST) (Post-treatment Survival Follow-up)
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: GNS561+TrametinibExperimental Treatment1 Intervention
Phase 1b Dose Finding Patients will receive GNS561 (50mg QD; 100mg QD; 150mg; 200mg QD) and trametinib (2mg QD; 1.5mg QD; 1mg QD) in a dose escalation/de-escalation design to determine the maximum tolerated dose (MTD) of the combination.
Experimental:
Phase 2a Patients will receive GNS561 and trametinib at the recommended dose of the combination determined during Phase 1b
Find a Location
Who is running the clinical trial?
GenfitLead Sponsor
19 Previous Clinical Trials
3,431 Total Patients Enrolled
Carol ADDY, M.D.Study DirectorGenfit
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for patients to participate in this trial?
"Indeed, the details provided on clinicaltrials.gov indicate that this ongoing trial is actively seeking eligible participants. The initial posting of the trial took place on August 21, 2023, and it was most recently updated on January 8, 2024. A total of three locations are involved in recruiting a cohort of 74 patients for this study."
Answered by AI
What is the upper limit for the number of participants enrolling in this medical study?
"Indeed, the details available on clinicaltrials.gov indicate that this particular clinical trial is actively seeking eligible participants. The study was initially posted on August 21st, 2023 and underwent its most recent update on January 8th, 2024. Recruitment aims to enroll a total of 74 individuals distributed across three distinct locations."
Answered by AI
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