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GNS561+Trametinib for Bile Duct Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Genfit

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 below

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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.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 42 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

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 more

Side effects data

From 2021 Phase 2 trial • 206 Patients • NCT02034110

58%

Pyrexia

42%

Nausea

35%

Vomiting

33%

Diarrhoea

33%

Fatigue

28%

Gamma-glutamyltransferase increased

28%

Chills

28%

Rash

26%

Aspartate aminotransferase increased

23%

White blood cell count decreased

23%

Cough

23%

Anaemia

23%

Decreased appetite

23%

Headache

21%

Constipation

21%

Blood alkaline phosphatase increased

19%

Dry mouth

19%

Hyperglycaemia

19%

Myalgia

16%

Alanine aminotransferase increased

16%

Asthenia

16%

Abdominal pain upper

16%

Thrombocytopenia

16%

Dyspnoea

14%

Hypertension

14%

Arthralgia

14%

Insomnia

12%

Platelet count decreased

12%

Eczema

12%

Blood creatinine increased

12%

Pruritus

12%

Abdominal pain

12%

Hypomagnesaemia

12%

Hyponatraemia

12%

Erythema

Oedema peripheral

Hypokalaemia

Dermatitis acneiform

Rash maculo-papular

Neutrophil count decreased

Weight increased

Back pain

Dry skin

Blood bilirubin increased

Sepsis

Neutropenia

Mucosal inflammation

Oedema

Cholangitis

Hypoalbuminaemia

Stomatitis

Dyspepsia

Influenza like illness

Herpes zoster

Glycosylated haemoglobin increased

Weight decreased

Musculoskeletal pain

Pain in extremity

Anxiety

Acute kidney injury

Night sweats

Hypophosphataemia

Skin lesion

Erythema nodosum

Dry eye

Toothache

Muscle spasms

Blood creatine phosphokinase increased

Hyperuricaemia

Gastrooesophageal reflux disease

Leukopenia

Folliculitis

Urinary tract infection

Fall

Lymphocyte count decreased

Hypoglycaemia

Joint swelling

Neuropathy peripheral

Epistaxis

Oropharyngeal pain

Acne

Hyperkeratosis

Femoral neck fracture

Productive cough

Hot flush

Hypersensitivity

Upper respiratory tract infection

Pain in jaw

Epilepsy

Peripheral sensory neuropathy

Depression

Hypercalcaemia

Dizziness

Skin mass

Pneumonia

Thrombophlebitis

Tachycardia

Musculoskeletal chest pain

Dysgeusia

Sciatica

Gastroenteritis

Febrile neutropenia

Atrial fibrillation

Oral pain

Rectal haemorrhage

Paronychia

Device related infection

Rhinitis

Sinusitis

Respiratory tract infection

Hyperkalaemia

Transaminases increased

Dehydration

Spinal pain

Haemorrhoids

Cataract

Eye pain

Vision blurred

Visual impairment

Abdominal discomfort

Abdominal distension

Gait disturbance

Non-cardiac chest pain

Xerosis

Conjunctivitis

Nasopharyngitis

Rash pustular

Tooth abscess

Tooth infection

Procedural pain

Blood lactate dehydrogenase increased

Blood uric acid increased

C-reactive protein increased

Muscular weakness

Neck pain

Basal cell carcinoma

Seborrhoeic keratosis

Paraesthesia

Proteinuria

Renal failure

Nasal congestion

Pleural effusion

Nail discolouration

Palmar-plantar erythrodysaesthesia syndrome

Photosensitivity reaction

100%

80%

60%

40%

20%

Study treatment Arm

Biliary Tract Cancer (BTC) (On-Treatment)

Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)

Multiple Myeloma (MM) (On-Treatment)

Anaplastic Thyroid Cancer (ATC) (On-Treatment)

Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)

Hairy Cell Leukemia (HCL) (On-Treatment)

Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)

Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)

High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)

High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)

Gastrointestinal Stromal Tumor (GIST) (On-Treatment)

Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)

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

0 / 6Eligibility criteria met

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

Recent research and studies

clinicaltrials.govStudy

Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutation Cholangiocarcinoma

2023. "Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutation Cholangiocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05874414.

All > Intrahepatic Cholangiocarcinoma > Bile Duct Cancer