Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trametinib

Protein Kinase Inhibitors

Enzyme Inhibitors

The dosage of trametinib for oral administration is 2mg once daily.

Trametinib 2 mg

Matthew Rettig, M.D.

The dosage of trametinib for oral administration is 2mg once daily. The patient is instructed to take the trametinib oncedaily dose at approximately the same time each day, by mouth with approximately 200 mL (almost 1 cup) of water on an empty stomach, either 1 hour before or 2 hours after a meal.

The dosage of trametinib for oral administration is 2mg once daily. The patient is instructed to take the trametinib once daily dose at approximately the same time each day, by mouth with approximately 200 mL (almost 1 cup) of water on an empty stomach, either 1 hour before or 2 hours after a meal.

The patient will be provided with complete dosing instructions from his treating physician. If the subject is instructed that if he vomits after taking either of the medications provided under this program, he should not retake the dose. The patient should take the next dose as originally scheduled. If a dose is missed, the patient should not double the next regularly scheduled dose. However, the patient can take the missed dose immediately if the next scheduled dose is at least 12 hours later. If the next scheduled dose is due in less than 12 hours, the patient is instructed to skip the dose and resume dosing the next day at the regular time. Then to take the next dose at the usual time the subject is scheduled to take it. It is not known for how long the subject will remain in the program because each patient may respond differently to the treatment. The length of time the patient will take trametinib therapy will depend on his cancer status and how well he tolerates the drugs. If he experiences severe side effects, he is instructed to call his treating physician immediately. The treating physician may advise him stop compassionate used of trametinib or may advise him to lower the dose. Trametinib may also be stopped completely at his Treating Physician's discretion. The treating physician will use his/her clinical expertise considering the intensity of the adverse effect and/or the results of your laboratory tests to make his/her decision. The Treating Physician may consult with the Novartis Country Pharma Organization Medical Advisor/Director about dose interruptions or modifications.

Compassionate Use: Progressive Metastatic Castrate Resistant Prostate Cancer; Monotherapy Treatment With Trametinib

Individual Patient Program for Patient With Progressive Metastatic Castrate Resistant Prostate Cancer; Monotherapy Treatment With Trametinib

Novartis

Jonsson Comprehensive Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Amino Acids

Ponatinib

Tyrosine Kinase Inhibitors

Tyrosine

Trametinib 0.5mg PO q daily Ponatinib 15mg PO q daily

Trametinib 1.0 mg PO q daily Ponatinib 15mg PO q daily

Trametinib 1.5 mg PO q daily 15mg PO q daily

Trametinib 2 mg PO q daily Ponatinib 15mg PO q daily

Trametinib 2 mg PO q daily Ponatinib 30mg PO q daily

Maximum tolerated dose as established in Phase I portion

Trametinib 0.5 mg

Trametinib 1 MG

Trametinib 1.5 MG

Ponatinib 15 MG

Ponatinib 30 MG

Kathryn Arbour, MD

The purpose of this study is to evaluate the safety of the combination of ponatinib and trametinib as well as the most appropriate dosages of the combination.

Trial of Trametinib and Ponatinib in Patients With KRAS Mutant Advanced Non-Small Cell Lung Cancer

A Phase 1 Trial of Trametinib and Ponatinib in Patients With KRAS Mutant Advanced Non-Small Cell Lung Cancer

In the Phase I portion of the study, a standard 3+3 design will be used to find the maximum tolerated dose.

In the Phase II portion of the study, RECIST criteria 1.1 will evaluate the overall response rate. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Memorial Sloan Kettering Cancer Center

No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms

Trametinib 0.5mg PO q daily Ponatinib 15mg PO q daily

Trametinib 0.5 mg: 0.5mg PO q daily

Ponatinib 15 MG: 15mg PO q daily

Phase I: Dose Level -3

Trametinib 1.0 mg PO q daily Ponatinib 15mg PO q daily

Trametinib 1 MG: 1.0 mg PO q daily

Ponatinib 15 MG: 15mg PO q daily

Phase I: Dose Level -2

Trametinib 1.5 mg PO q daily 15mg PO q daily

Trametinib 1.5 MG: 1.5mg PO q daily

Ponatinib 15 MG: 15mg PO q daily

Phase I: Dose Level -1

Trametinib 2 mg PO q daily Ponatinib 15mg PO q daily

Trametinib 2 mg: 2 mg PO q daily

Ponatinib 15 MG: 15mg PO q daily

Phase I: Dose Level 1

Trametinib 2 mg PO q daily Ponatinib 30mg PO q daily

Trametinib 2 mg: 2 mg PO q daily

Ponatinib 30 MG: 30mg PO q daily

Phase I: Dose Level 2

Maximum tolerated dose as established in Phase I portion

Trametinib 2 mg: 2 mg PO q daily

Ponatinib 15 MG: 15mg PO q daily

Phase II

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

No participants were enrolled in "Phase I: Dose Level -3", "Phase I: Dose Level -2", "Phase I: Dose Level -1" and "Phase II" arms due to cardiovascular events observed at Dose Level 2

Dr. Kathryn Arbour

Dose Level 1: Trametinib 2 mg PO q daily Ponatinib 15mg PO q daily Dose Level 2: Trametinib 2mg, Ponatinib 30mg

Phase I: Dose Level 1 and Dose Level 2

Maximum Tolerated Dose of Ponatinib, Phase I

Cardiovascular events were observed at Dose Level 2 and continued exploration of other dose levels did not proceed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Compassionate Use: Progressive Metastatic Castrate Resistant Prostate Cancer; Monotherapy Treatment With Trametinib	NCT03386071	Progressive Met...	Trametinib 2 mg	18 Years -	Jonsson Comprehensive Cancer Center
Trial of Trametinib and Ponatinib in Patients With KRAS Mutant Advanced Non-Small Cell Lung Cancer	NCT03704688	Non Small Cell ... KRAS Gene Mutat...	Trametinib 0.5 ... Trametinib 1 MG Trametinib 1.5 ... Trametinib 2 mg Ponatinib 15 MG Ponatinib 30 MG	19 Years -	Memorial Sloan Kettering Cancer Center

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