← Back to Search

Protein Inhibitor

Trametinib for Solid Tumors

Phase 1 & 2
Waitlist Available
Led By Ryan B Corcoran
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
Able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 7, 8, 21, and 22 (or days 7, 8, 14, and 15) of cycle 1, and day 1 of cycles 2, 4, 8, and 12
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of two drugs, trametinib and navitoclax, for treating patients with advanced or metastatic solid tumors. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and navitoclax may stop the growth of cancer cells by blocking proteins needed for cancer cell survival.

Who is the study for?
Adults with advanced or metastatic solid tumors that have a specific mutation (KRAS or NRAS) and have failed previous chemotherapy can join this trial. They must be able to take oral medication, not have significant heart disease, bleeding disorders, brain metastases, certain viral infections, or recent major surgery.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Trametinib and Navitoclax. It aims to find the best dose and see how well they work together in stopping tumor growth by blocking enzymes and proteins cancer cells need to survive.See study design
What are the potential side effects?
Possible side effects include diarrhea, rash, fatigue, liver enzyme changes leading to potential liver damage; risk of bleeding; heart problems; eye issues like blurred vision; high blood pressure; and skin problems such as acneiform dermatitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take pills and don't have major stomach or bowel issues affecting drug absorption.
Select...
I am 18 years old or older.
Select...
My cancer is confirmed to have specific KRAS or NRAS mutations and cannot be surgically removed.
Select...
I have a tumor that can be measured with imaging tests.
Select...
I've had chemotherapy before and my cancer either got worse or I couldn't tolerate the treatment.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My heart's pumping ability is within the normal range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 7, 8, 21, and 22 (or days 7, 8, 14, and 15) of cycle 1, and day 1 of cycles 2, 4, 8, and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 7, 8, 21, and 22 (or days 7, 8, 14, and 15) of cycle 1, and day 1 of cycles 2, 4, 8, and 12 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 adverse events (Phase Ib and II)
Progression-free survival (Phase II)
Response rate (partial response [PR] + complete response [CR]) (Phase II)
Secondary outcome measures
Percent change in levels of apoptosis markers (cleaved caspase-3) (Phase Ib and II)
Percent change in levels of proliferation markers (Ki67) (Phase Ib and II)
Percent change in levels of proteins/messenger ribonucleic acid (mRNA)s implicated in MAPK or B-cell lymphoma 2 family signaling (Phase Ib and II)
+4 more

Side effects data

From 2021 Phase 2 trial • 206 Patients • NCT02034110
47%
Pyrexia
36%
Fatigue
33%
Anaemia
33%
Nausea
33%
Decreased appetite
28%
Rash
22%
Headache
22%
Constipation
22%
Pneumonia
22%
Chills
22%
Dyspnoea
19%
Dizziness
19%
Hypoalbuminaemia
19%
Vomiting
19%
Diarrhoea
19%
Hyponatraemia
17%
Dysphagia
17%
Blood alkaline phosphatase increased
17%
Back pain
14%
Aspartate aminotransferase increased
14%
Hypocalcaemia
14%
Dry mouth
14%
Hyperglycaemia
14%
Arthralgia
14%
Oedema peripheral
14%
White blood cell count decreased
14%
Insomnia
14%
Hypotension
11%
Haemoptysis
11%
Hypokalaemia
11%
Dry skin
11%
Hypothyroidism
11%
Pruritus
11%
Visual impairment
11%
Alanine aminotransferase increased
11%
Weight decreased
11%
Cough
8%
Upper respiratory tract infection
8%
Rash maculo-papular
8%
Productive cough
8%
Mucosal inflammation
8%
Hypercalcaemia
8%
Gastrooesophageal reflux disease
8%
Pleural effusion
8%
Night sweats
8%
Asthenia
8%
Ejection fraction decreased
8%
Electrocardiogram QT prolonged
8%
Gamma-glutamyltransferase increased
8%
Neutrophil count decreased
8%
Neck pain
6%
Acute kidney injury
6%
Rhinorrhoea
6%
Skin lesion
6%
Seborrhoeic keratosis
6%
Haematochezia
6%
Thrombocytopenia
6%
Atrial fibrillation
6%
Stomatitis
6%
Rhinitis allergic
6%
Tachycardia
6%
Abdominal pain upper
6%
Hyperuricaemia
6%
Leukopenia
6%
Sinusitis
6%
Urinary tract infection
6%
Polyneuropathy
6%
Haematuria
6%
Neutropenia
6%
Ear pain
6%
Abdominal pain
6%
Feeling cold
6%
Non-cardiac chest pain
6%
Pain
6%
Fungal infection
6%
Nasopharyngitis
6%
Blood creatinine increased
6%
Blood urea increased
6%
Neutrophil count increased
6%
Hypomagnesaemia
6%
Myalgia
6%
Neuropathy peripheral
6%
Proteinuria
6%
Nasal congestion
6%
Pneumonitis
6%
Pulmonary embolism
6%
Palmar-plantar erythrodysaesthesia syndrome
3%
Dermatitis acneiform
3%
Femoral neck fracture
3%
Cataract
3%
Pelvic infection
3%
Sepsis
3%
Rhabdomyolysis
3%
Hyperglycaemic hyperosmolar nonketotic syndrome
3%
Erythema nodosum
3%
Malaise
3%
Flushing
3%
Oesophageal stenosis
3%
Atrioventricular block first degree
3%
Photophobia
3%
Dehydration
3%
Toothache
3%
Oral candidiasis
3%
Urinary retention
3%
Alopecia
3%
Skin mass
3%
Aspiration
3%
Aortic thrombosis
3%
Vision blurred
3%
Oedema
3%
Depression
3%
Folliculitis
3%
Staphylococcal infection
3%
Clavicle fracture
3%
Aphasia
3%
Cardiac ventricular thrombosis
3%
Stress cardiomyopathy
3%
Oral pain
3%
Clostridium difficile infection
3%
Diverticulitis
3%
Pneumonia aspiration
3%
Pneumonia necrotising
3%
Wound infection
3%
Hyperkalaemia
3%
Rib fracture
3%
Bladder transitional cell carcinoma
3%
Facial nerve disorder
3%
Hypertension
3%
Paralysis recurrent laryngeal nerve
3%
Syncope
3%
Hallucination
3%
Pulmonary haematoma
3%
Sinus bradycardia
3%
Tinnitus
3%
Dry eye
3%
Abdominal distension
3%
Dyspepsia
3%
Gait disturbance
3%
Nodule
3%
Xerosis
3%
Conjunctivitis
3%
Tooth infection
3%
Procedural pain
3%
Blood creatine phosphokinase increased
3%
Platelet count decreased
3%
Weight increased
3%
Hypophosphataemia
3%
Flank pain
3%
Muscular weakness
3%
Musculoskeletal chest pain
3%
Pain in extremity
3%
Hypoaesthesia
3%
Paraesthesia
3%
Anxiety
3%
Sleep disorder
3%
Pollakiuria
3%
Dysphonia
3%
Epistaxis
3%
Upper-airway cough syndrome
3%
Wheezing
3%
Erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anaplastic Thyroid Cancer (ATC) (On-Treatment)
Biliary Tract Cancer (BTC) (Post-treatment Survival Follow-up)
Gastrointestinal Stromal Tumor (GIST) (Post-treatment Survival Follow-up)
Biliary Tract Cancer (BTC) (On-Treatment)
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
Gastrointestinal Stromal Tumor (GIST) (On-Treatment)
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
Adenocarcinoma of the Small Intestine (ASI) (On-Treatment)
Hairy Cell Leukemia (HCL) (On-Treatment)
Multiple Myeloma (MM) (On-Treatment)
Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)
Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)
Multiple Myeloma (MM) (Post-treatment Survival Follow-up)
High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)
Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)
Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (trametinib, navitoclax)Experimental Treatment7 Interventions
Patients receive trametinib PO QD and navitoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. If unacceptable toxicity is observed, patients may receive trametinib PO QD on days 1-14.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1920
Computed Tomography
2017
Completed Phase 2
~2790
Magnetic Resonance Imaging
2017
Completed Phase 3
~1310
Positron Emission Tomography
2008
Completed Phase 2
~2260
Trametinib
2014
Completed Phase 2
~1600
Navitoclax
2012
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,549 Total Patients Enrolled
Ryan B CorcoranPrincipal InvestigatorDana-Farber Cancer Institute

Frequently Asked Questions

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

Are we able to sign up for the trial at this time?

"This study is not seeking patients at the moment. According to the latest update on 11/8/2022, this trial was initially posted on 3/7/2014. If you're interested in other studies, there are 2467 trials for malignant neoplasms and 107 Trametinib studies that are still enrolling patients."

Answered by AI

What other research exists in this area?

"Trametinib has been researched since 2009. The very first study was conducted in 2009 and was sponsored by AbbVie (prior sponsor, Abbott). Following the first trial in 2009, which involved 29 patients, Trametinib received its Phase 1 drug approval. Today there are 107 live studied for Trametinib across 1298 cities and 45 countries."

Answered by AI

What are the main goals that researchers hope to achieve with this trial?

"The goal of this study is to assess progression-free survival over a period of up to 30 days. Secondary outcomes include response rate (partial response + complete response) and pharmacokinetic parameters for trametinib and navitoclax when administered in combination. Results will be reported as a percent (%) increase or decrease in level of a given marker after treatment initiation (post treatment biopsy) relative to before treatment (pre-treatment biopsy)."

Answered by AI

Are there other instances where Trametinib has been used in research?

"Out of the 107 ongoing Trametinib studies, 8 have reached Phase 3. The high number of trials for this treatment is due in part to the popularity of the medication. Duarte, California serves as the headquarters for many of these clinical trials; however, there are 6580 total locations running Trametinib trials."

Answered by AI

How many test subjects are needed for this research?

"This research is not currently looking for new participants. The earliest posting was on March 7th, 2014 with the most recent update being November 8th, 2029. There are 2467 other studies actively recruiting patients for malignant neoplasms and 107 clinical trials involving Trametinib that are still enrolling individuals."

Answered by AI
~9 spots leftby Mar 2025