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| Name | Class |
|---|---|
| Array BioPharma | INDUSTRY |
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The main purpose of this study is to find out if the drugs MEK162 and erlotinib (Tarceva) given in combination are safe and have beneficial effects in patients who have NSCLC.
The U.S. Food and Drug Administration (FDA) has not approved MEK162 for use to treat NSCLC. Erlotinib is an FDA approved drug for the treatment of Non-Small Cell Lung Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I - Dose Escalation | Experimental | For the Phase I portion, patients will start MEK162 by mouth (p.o.) on cycle 1, day 1 and erlotinib on cycle 1, day 2. The MEK162 will be dosed once daily (QD) or twice (b.i.d.), and erlotinib will be dosed daily (QD) on a 28-day cycle. Phase I will be followed by an expansion Phase Ib. |
|
| Arm A: Dose Expansion | Experimental | Phase Ib Arm A: EGFR Mutant Tumor Status. In the phase IB expansion cohort study there are 2 arms based on the presence of the EGFR (Arm A) or KRAS (Arm B) mutation. The treatments for each arm are the same: MEK162 (2 time a day) and erlotinib (once) daily on 28 day cycles. |
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| Arm B: Dose Expansion | Experimental | Phase Ib Arm B: KRAS Mutant Tumor Status. In the phase IB expansion cohort study there are 2 arms based on the presence of the EGFR (Arm A) or KRAS (Arm B) mutation. The treatments for each arm are the same: MEK162 (2 time a day) and erlotinib (once) daily on 28 day cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEK162 | Drug | Treatment as outlined in study arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Maximum Tolerated Dose (MTD) | To evaluate the safety of MEK162 plus erlotinib in patients with advanced NSCLC by evaluating toxicities of therapy and establish a recommended phase IB dosing of MEK162 and erlotinib. Safety population: consists of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Progression Free Survival (PFS) | PFS is defined as the duration of time from the time of randomization to time of disease progression or death, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jhanelle Gray, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37499521 | Derived | Saltos AN, Creelan BC, Tanvetyanon T, Chiappori AA, Antonia SJ, Shafique MR, Ugrenovic-Petrovic M, Sansil S, Neuger A, Ozakinci H, Boyle TA, Kim J, Haura EB, Gray JE. A phase I/IB trial of binimetinib in combination with erlotinib in NSCLC harboring activating KRAS or EGFR mutations. Lung Cancer. 2023 Sep;183:107313. doi: 10.1016/j.lungcan.2023.107313. Epub 2023 Jul 22. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C581313 | binimetinib |
| D020929 | Mitogen-Activated Protein Kinase Kinases |
| D000069347 | Erlotinib Hydrochloride |
| D066246 | ErbB Receptors |
| D000092004 | Tyrosine Kinase Inhibitors |
| ID | Term |
|---|---|
| D017346 | Protein Serine-Threonine Kinases |
| D011494 | Protein Kinases |
| D017853 | Phosphotransferases (Alcohol Group Acceptor) |
| D010770 | Phosphotransferases |
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| Erlotinib | Drug | Treatment as outlined in study arms. |
|
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| 6 months |
| Number of Participants with Overall Survival (OS) | OS, defined as the time from study enrollment to death from any cause during the study duration. | 3 years |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D011505 | Protein-Tyrosine Kinases |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D020794 | Receptor Protein-Tyrosine Kinases |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D017978 | Receptors, Growth Factor |
| D018000 | Receptors, Peptide |
| D047428 | Protein Kinase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |