Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Anti-Infective Agents

Dermatologic Agents

All Drugs and Chemicals

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

Antineoplastic Agents

Amino Acids

Salicylic Acid

Aspirin

Ponatinib

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

Patients will be treated with ponatinib 15 mg/day plus 100 mg/day ASA for 104 weeks. After that, ponatinib and ASA will be stopped.

Patients will receive ponatinib 15 mg/day for 104 weeks orally. Ponatinib will be self-administered by the patient on a daily schedule.

Acetyl salicylic acid (ASA) (100 mg) will be used such auxiliary medicinal product in order to prevent vascular occlusive events related with ponatinib.

Ponatinib 15 MG

Patients will receive acetylsalicylic acid 100 mg/day for 104 weeks orally.

Acetylsalicylic acid 100 MG

Joaquín Martínez López, MD

Valentín García Gutierrez, MD

Juan Carlos Hernández Boluda, MD

The purpose of the present study is to determine the rate of successful treatment-free remission (TFR) within the first 52 weeks following cessation of ponatinib treatment in patients who achieved MR4. Eligible patients had been previously treated with TKI and when patients achieved an optimal molecular response, TKI treatment was discontinued. After loss of response, patients were treated again with a TKI treatment and have documented MR4 for one year at the time of switch to ponatinib to study entry. MR4 is defined as BCR-ABL transcript level ≤ 0.01% IS or undetectable BCR-ABL levels with sample sensitivity of at least 4 log.

Study to Evaluate the Reinduction and Second Stop of TKI With Ponatinib in CML in Molecular Response (ResToP)

Multicenter, Open-Label, Single Arm, Phase II Exploratory Study to Evaluate the Reinduction and Second Stop of TKI With Ponatinib in CML in Molecular Response (ResToP)

The number of patients who achieve a MR 5 at ponatinib therapy cessation divided by the number of patients who entered ponatinib TFR phase.

This variable is defined as the number of patients who have a maintained MMR and have not restarted TKI therapy in the first 52 weeks after starting ponatinib TFR phase divided by the number of patients who entered ponatinib TFR phase.

The number and percentage of patients with treatment-emergent adverse events (new or worsening from baseline) will be summarized by system organ class (SOC) and/or preferred term (PT), severity (based on CTCAE grades), type of adverse event and relation to study treatment.

The number and percentage of patients with thromboembolic events will be summarized by preferred term, severity (based on CTCAE grades), type of adverse event, relation to study treatment by the phases or subsets previously described.

The number and percentage of patients with hemorrhagic events will be summarized by preferred term, severity (based on CTCAE grades), type of adverse event, relation to study treatment by the phases or subsets previously described.

The number and percentage of patients with hemolytic events will be summarized by preferred term, severity (based on CTCAE grades), type of adverse event, relation to study treatment by the phases or subsets previously described.

The number and percentage of patients with gastrointestinal events will be summarized by preferred term, severity (based on CTCAE grades), type of adverse event, relation to study treatment by the phases or subsets previously described.

Number of patients still in MR4 and have not restarted TKI therapy in the first 52 weeks after starting ponatinib TFR phase divided by the number of patients who entered ponatinib TFR phase.

The number of patients who still have a MMR and have not restarted TKI therapy in the first 24 weeks after starting ponatinib TFR phase divided by the number of patients who entered ponatinib TFR phase.

Time from start ponatinib treatment to the occurrence of progression to AP/BC, loss of MMR or death from any cause, the earliest of these events.

time from ponatinib cessation to the occurrence of loss of MMR, restart of TKI treatment, progression of AP/BC, or death from any cause, the earliest of these events.

Incyte Biosciences UK

Apices Soluciones S.L.

Fundacion CRIS de Investigación para Vencer el Cáncer

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

Trametinib

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

Trametinib 2 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
Study to Evaluate the Reinduction and Second Stop of TKI With Ponatinib in CML in Molecular Response (ResToP)	NCT04160546	Chronic Myeloid...	Ponatinib 15 MG Acetylsalicylic...	18 Years -	Fundacion CRIS de Investigación para Vencer el Cáncer
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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