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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

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I can take pills and don't have major stomach or bowel issues affecting drug absorption.

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I am 18 years old or older.

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My cancer is confirmed to have specific KRAS or NRAS mutations and cannot be surgically removed.

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I have a tumor that can be measured with imaging tests.

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I've had chemotherapy before and my cancer either got worse or I couldn't tolerate the treatment.

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I am fully active and can carry on all pre-disease activities without restriction.

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My heart's pumping ability is within the normal range.

Timeline

Screening ~ 3 weeks3 visits

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

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

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

Rash maculo-papular

Oedema peripheral

Hypokalaemia

Dermatitis acneiform

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)

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)

Multiple Myeloma (MM) (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: 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

~1700

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Positron Emission Tomography

2008

Completed Phase 2

~2240

Trametinib

2014

Completed Phase 2

~1550

Navitoclax

2012

Completed Phase 2

~90

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,930,274 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

Recent research and studies

clinicaltrials.govStudy

Trametinib and Navitoclax in Treating Patients With Advanced or Metastatic Solid Tumors

2014. "Trametinib and Navitoclax in Treating Patients With Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02079740.

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